A Psychotherapy Development Study for a New Addictive Disorder
Phase: NA
Conditions: Internet Gaming Disorder
Sponsor: UConn Health

 
 
A Psychotherapy Development Study for Internet Gaming 
NCT03220581 
Protocol & Statistical Analysis Plan 
 
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Protocol: A psychotherapy development study for internet gaming
Principle Investigator: Kristyn Zajac, Ph.D.
Abstract
The fifth edition of the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) introduces 
Internet gaming disorder (IGD) as a Substance-Related and Addictive Disorder in Section 3, Conditions for 
Further Study. Although research is in the nascent stages, existing studies demonstrate that IGD is associated 
with psychosocial distress including suicidality, and adverse vocational and educational outcomes in youth.  
Internet gaming disorder also shares substantial overlap with substance use, and it primarily affects 
adolescents, who rarely seek treatment on their own. Parents more often express concerns about their child’s 
game playing behaviors, and data suggest that parents can have strong influences on it. This psychotherapy 
development study will evaluate feasibility, acceptability, and effect sizes of a behavioral intervention designed 
to help parents reduce gaming problems in their children. Sixty concerned parents and their children will 
complete parental and self-report inventories and structured diagnostic interviews regarding the child’s gaming 
behaviors, substance use and psychosocial functioning. Participants will be randomized to either a control 
condition consisting of referral for mental health issues and family support services or to the same plus a 6-
week family-based behavioral intervention designed to assist with better monitoring and regulating the child’s 
game playing behaviors and encouraging and rewarding alternatives to game playing. Gaming and other 
problems will be assessed pre-treatment, mid-treatment, at the end of treatment, and at a 4-month follow-up. 
This study is unique in evaluating initial psychometric properties of a parental version of a measure that uses 
the DSM-5 criteria for IGD in a clinical sample, and it will also assess associations of IGD with substance use, 
psychological symptoms, and family functioning over time. Most importantly, this study will be the first 
randomized trial of an intervention designed to reduce gaming problems, and results are likely to guide future 
research and treatment efforts related to this condition.
Specific aims  
Internet gaming disorder (IGD) affects about 1%-2% of the population, and primarily adolescent males. 
This grant application represents the first randomized study of treatments for IGD. 
There are four important and timely reasons why a study of interventions for youth with gaming 
problems is necessary. First, this condition is gaining international attention with its recent inclusion in the 
DSM-5. Second, IGD shares extensive overlap with substance use disorders with respect to comorbidity, risk 
factors and presenting features. Third, IGD is associated with adverse consequences that parallel many of 
those related to substance use disorders, such as poor school performance and serious physical and mental 
health outcomes including suicidality. Finally, efficacious treatments for this condition may reverse or minimize 
its adverse effects, and youth who are still living with their families can benefit from parental support in 
reducing gaming problems. Although clinicians are already treating this condition primarily in specialized 
residential programs, there are no systematic evaluations of interventions designed to reduce gaming 
problems and no empirically based guidelines for clinicians treating this condition on an outpatient basis. 
 We adapted principles and theories of behavioral and family-based interventions for substance use 
disorders for IGD. In this pilot study, 60 parents and their children with IGD will be randomly assigned to one of 
two conditions: referral to services for related conditions, or the same plus a 6-week behavioral family 
intervention in which parents and children will meet weekly with a therapist to learn to monitor game playing, 
restructure the environment to be less conducive toward playing, set realistic goals related to frequency of 
game playing, and encourage and reward behaviors incompatible with game playing. Sessions will also focus 
on improving parent-child communication. Parents and children will complete evaluations assessing gaming, 
substance use, attention problems, and psychosocial functioning pre-, mid-, and post-treatment and 4 months 
later. 
Specific aims are:
1.
To evaluate the feasibility and acceptability of this intervention. The proportion of participants who 
complete 6 sessions will be determined, along with parent and child satisfaction ratings of the treatment. 
We will consider the treatment feasible and acceptable if we are able to recruit the full sample and 70% or 
more of the families complete treatment and express moderate to high levels of satisfaction overall and 
with the majority of the session topics. 
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2.
To examine the effect size of the intervention in reducing gaming. Parent and child reports of 
frequencies and durations of game playing will be compared over time between conditions to derive effect 
size estimates. We hypothesize that the behavioral family intervention will reduce the frequency and 
duration of game playing episodes relative to the control condition. We also expect that a lower proportion 
of youth in the intervention condition will meet current DSM-5 criteria for IGD following treatment.
 
Exploratory aims are to examine putative mechanisms of change including structural changes in the 
home environment, frequencies of monitoring gaming, participation in alternate activities, and family 
communication and functioning. If we can identify potential mechanisms of change for gaming behavior, we 
can focus subsequent psychotherapy development efforts on addressing those processes more directly. 
We will also assess the effect size of the intervention on secondary outcomes including indices of 
substance use, attention problems, depression, sleep, psychosocial functioning and quality of life. We expect 
that the intervention will result in improvements along some or most of these domains if it yields benefits in 
reducing gaming. 
In addition, we will evaluate concordance between parent and child reports on measures of gaming and 
gaming problems. These data will help inform development of diagnostic and assessment tools for IGD.  
If the intervention is feasible and acceptable and medium or larger effect sizes are noted for decreasing 
gaming, we will propose a larger scale, longer-term study after modifying the intervention based on 
experiences with this pilot study. Even in the absence of treatment-specific effects, these results will provide 
valuable information about how gaming and psychosocial functioning change over time and about the 
relationship between gaming and other addictive behaviors (i.e., substance abuse) in a clinical population. 
Further, the study has the potential to shed light on important mechanisms of change for youth behaviors in the 
context of a family-based addiction treatment, an area understudied in substance abuse treatment as well. 
Given increasing scientific interest in IGD, this novel study is timely and critical for addressing concerns related 
to this emerging public health issue.
Background and significance
          The vast majority of children play video or electronic games. A nationally representative study of US 
youth ages 8-18 years found that 88% played games electronically, 68% played at least weekly, and 23% daily 
(Gentile, 2009). On the 2013 Youth Risk Behavior Surveillance System, 41% reported using computers for 
non-school work and gaming an average of >3 hours per day (Kann et al., 2014). Although most video game 
playing is harmless, excessive play can lead to psychosocial and even medical problems such as game-
induced seizures and deaths (BBC, 2005; Chuang, 2006; Reuters, 2007). Although very few cases rise to 
these extremes, governments of some Asian countries have declared problem game playing to reach epidemic 
proportions. Providers have established specialized treatment clinics around the world, including in the US.  
            The American Medical Association (2007) called for consideration of a condition related to excessive 
gaming as a mental disorder, and the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders 
(DSM-5; APA, 2013) includes Internet gaming disorder (IGD) as a Substance-Related and Addictive Disorder 
in Section 3, “Conditions for Further Study.” This designation recognizes the personal and public health 
significance of the condition, and it encourages further research of its diagnosis, comorbidities, and biological 
underpinnings, as well as its natural progression and treatment.  This study will address many of these issues. 
Diagnosis. The DSM-5 lists 9 criteria for IGD, and an international group (Petry et al., 2014) suggests their 
operationalization. Ko et al. (2014) administered clinical interviews based on the DSM-5 criteria to young adults 
in Taiwan: those with current gaming problems; those with past problems; and those who never had problems. 
Meeting >5 criteria best distinguished those with “normal” levels of play from those with problems, and the 
specific criteria had adequate to good diagnostic accuracy, providing support for the DSM-5 classification 
system. We (Rehbein et al., 2015) developed a screening instrument, Video Game Dependency Scale 
(VGDS), based on DSM-5 criteria and administered it to 11,003 students; it had excellent reliability and 
discriminant validity. This study will be the first to evaluate the psychometrics of a parental version of the 
VGDS, and it will assess concordance between parent and child reports of symptoms and diagnosis. 
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Risk factors. Although an understanding of IGD is in early stages, male gender is clearly a risk factor. 
Regardless of how gaming problems are classified, studies ubiquitously find higher rates of game playing and 
problems in males than females (Choo et al., 2010; Desai et al., 2010; Mentzoni et al., 2011). In our DSM-5 
evaluation of IGD (Rehbein et al., 2015), 2.0% of males had IGD versus 0.3% of females. Younger age is 
consistently associated with gaming as well. Using less stringent classification systems than the DSM-5, Festl 
et al. (2013) found a 7.6% prevalence rate of gaming problems for youth under 19 years and a 3.7% rate for 
those 20 and older. Mentzoni et al. (2011) noted that 15.4% of males aged 16-21 years, and 9.7% of males 
aged 22-27, had gaming problems; rates in other age groups, and for females of all ages, were under 3%. 
Gaming problems are also linked to drug use, and particularly illicit drug use. In a study of over 4500 
students, boys who used marijuana, nicotine, and alcohol were substantially more likely to report problems with 
gaming than non-users (Van Rooij et al., 2014). In a survey of nearly 2000 video game players, Porter et al. 
(2010) found no differences between those with and without gaming problems in terms of alcohol use, but 
those with gaming problems were more likely to use illicit drugs. Walther et al. (2012) evaluated over 2500 
students and found no association between alcohol and nicotine use and gaming but a positive relationship 
with marijuana use. In CT, where the proposed study will be conducted, Desai et al. (2010) surveyed over 
4000 high school students, and 4.7% of the video game players reported problems with their playing; although 
drinking did not differ based on gaming problems, problem gamers more often used nicotine and illicit drugs. 
Substance use and gaming may also share a neurobiological basis, with fMRI studies finding some similar 
deficits in pre-frontal cortex functioning (e.g., Chen et al. 2014; Han et al. 2010; Kim et al. 2015; Ko et al. 2013, 
2105).  
Attention deficit hyperactivity disorder (ADHD), social anxiety, depression and suicidality are related to 
IGD as well. In cross sectional studies, persons with gaming problems have greater ADHD symptoms (Choo et 
al., 2010; Gentile, 2009; Rehbein et al., 2010) and depression (Desai et al., 2010; Mentzoni et al., 2011; van 
Rooij et al., 2010) and lower sociability and social competence than those without (Festl et al., 2013; Lemmens 
et al., 2009; Lo et al., 2005; Rehbein et al., 2010). In a prospective study of over 1,300 youth, Swing et al. 
(2010) found game playing correlated with more attention problems initially, and this relationship persisted 
throughout a 13-month period. Among over 700 youth, heavy game playing was associated with an increase in 
depression over the one-year study period, and greater depression predicted more game playing as well as 
withdrawal from sports and other activities (Romer et al., 2013). Gentile et al. (2011) followed over 3000 
students for 2 years and found that as gaming became more pronounced, depression, anxiety, and social 
phobia symptoms increased while school performance suffered. Excessive gaming is also related to suicidality 
(e.g., Messias et al., 2011; Rehbein et al., 2010), further underscoring its public health significance. 
Thus, drug use and psychological symptoms are correlated with and likely involved in the development 
of IGD and/or arise from it. However, the few available longitudinal studies reported upon natural changes over 
time. They did not address how treatment impacts changes in gaming and related problems. 
Treatments. Reviews of treatment for IGD (King et al., 2011; Petry et al., 2015; Winkler et al., 2013) find few 
randomized trials exist. Most interventions involve intensive multi-modal therapy provided in residential care 
(Cash et al., 2012; Koo et al., 2011; Rumpf et al., 2014; Shek et al., 2009). Few patients, and typically the most 
severe, seek residential care. This level of care is also expensive, and it is likely more cost-effective to provide 
effective outpatient services to individuals before problems become severe enough to warrant residential care. 
Young (2007) describes cognitive-behavioral therapy (CBT) to treat outpatients with Internet problems 
more generally, i.e., not limited to gaming. In a non-randomized evaluation, most of 114 adults who received 
this treatment reduced symptoms by the 8th session, and improvements were maintained through a 6-month 
follow-up. In one of the only randomized trials, Du et al. (2010) assigned 56 youth in Shanghai to 8 sessions of 
CBT or a no treatment control. Internet use decreased similarly in both groups, but those assigned to CBT had 
improvements in time management skills and reductions in psychological symptoms relative to controls. Jager 
et al. (2012) describe an ongoing study in Germany comparing CBT to a wait-list control. That study will be the 
first large scale randomized study of treatment for “Internet addiction,” but it is not limited to persons with 
gaming problems, who differ substantially from those with general “Internet addiction” in terms of 
demographics, comorbidities, severity and course (Kiraly et al., 2014; Ko et al., 2007; Li et al., 2014; van Rooij 
et al., 2010).  
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This study focuses on developing an intervention specifically for gaming, the Internet-based activity 
most likely to lead to clinically significant problems (Kiraly et al., 2014; Ko et al., 2007; Li et al., 2014; van Rooij 
et al., 2010).  IGD is conceptualized similarly to other common problems in adolescence, including substance 
use disorders, and these disorders are strongly influenced by family systems and respond well to approaches 
that target family interactions and improve both monitoring and contingencies around the problem behaviors 
(Hogue & Little, 2009; NIDA, 2014). Further, few youth or young adults seek mental health treatment generally 
or addictions treatment specifically (Alegria et al., 2011; SAMHSHA 2009ab). More often, parents express 
concerns, and decades of research on adolescent substance abuse treatment demonstrate the strongest 
evidence base for family-based interventions (Tanner-Smith et al., 2013; Waldron & Turner, 2008). Therefore, 
this study will focus on treating parents along with their children. 
Similar to the substance abuse field, parental involvement, particularly monitoring and supervision, can 
have strong influences on children’s game playing (e.g., Lin et al., 2009; Young, 2009). Allowing video game 
systems in a child’s bedroom relates to more frequent playing (Roberts & Foehr, 2008) and greater use of 
violent and mature-rated games (Olson et al., 2007). Parental guidelines related to playing time are inversely 
associated with excessive playing as well. Carlson et al. (2010) surveyed 7,415 youth and found those who 
reported their parents had well-defined rules regarding playing were less likely to play excessively than those 
whose parents did not. In addition, frequent monitoring of behaviors is associated with improved outcomes 
along many dimensions (e.g., Michie et al., 2012; Steinberg et al., 2013). In a longitudinal study of parental 
monitoring of children’s media usage including game playing, greater monitoring had benefits on academic 
performance, social functioning and sleep (Gentile et al., 2014). The intervention we developed teaches 
parents, as well as children, to monitor game playing and to establish and maintain clear expectations. It 
provides communication skills training and also assists parents in restructuring home environments to be less 
conducive toward game playing and to encourage other recreational activities. Borrowing from effective 
behavioral family interventions for substance use disorders (Meyers et al., 1998; Miller et al., 1999; Stanger et 
al., 2009; Waldron et al., 2007), the treatment also encourages use of positive contingencies for non-game 
playing behaviors. In an uncontrolled study of brief family therapy for IGD, Han et al. (2012) found 
improvements in family cohesion were related to decreases in gaming along with increases in caudate nucleus 
activity in response to affection stimuli, suggesting a role for family therapy and a possible biological 
mechanism underlying response to it.
This stage 1 pilot study is designed to assess feasibility, acceptability and effect sizes of a family based 
behavioral intervention for reducing gaming in youth. Consistent with guidelines for psychotherapy 
development (Carroll & Onken, 2005; Onken et al., 2014; Rounsaville et al., 2000), it incorporates all 
components of Stage 1 research such as identifying a target population and outcomes, outlining therapeutic 
procedures based on theoretical models, and specifying and measuring potential change mechanisms. As 
such, this study will provide a strong foundation for informing future research and clinical treatment with this 
population. 
This study is innovative on several levels: 1) it is the first randomized trial of an intervention specifically 
directed toward IGD; 2) it examines potential mechanisms of change, including environmental changes 
(removal or relocation of devices in the home) and monitoring gaming, participation in alternate activities, and 
family functioning and communication; 3) it assesses comorbidities of gaming, substance use, and related 
conditions and evaluates changes in these symptoms over time; and 4) it is the first to evaluate psychometric 
properties of a parental assessment tool based on the DSM-5 IGD criteria, a critical aspect for diagnoses of 
youth. Results will provide valuable information on the nature, course, and treatment of this new “addictive 
disorder.” 
Preliminary studies. This team has extensive experience in areas of direct relevance to this proposal. First, 
Dr. Petry has received nearly 20 years of continuous NIDA funding to develop and evaluate behavioral 
therapies for drug use disorders. She was also awarded the first NIH grant for treatment of another non-
substance addictive disorder-- gambling disorder. Her work on gambling is internationally renowned (see 
biosketch). 
Second, Dr. Petry has adapted behavioral therapies for use with adolescents and youth (e.g., DP3-
DK097705; Godley et al., 2014; Petry et al., 2009,2015bc) and is joined by adolescent clinical psychologists: 
Drs. Zajac and Chang. Dr. Chang has 15 years’ experience treating adolescents in family therapy, and Dr. 
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Zajac has a NIDA-funded K23 to evaluate behavioral therapy for transition age youth with drug use disorders. 
She also served as the director of an adolescent substance abuse clinic at the Medical University of SC. 
Dr. Cash and Ms. Rae are leading authorities on treating IGD. They founded the first residential 
program dedicated to treating this condition and recognize the need for earlier, family-based interventions. As 
consultants, they will provide invaluable input to the therapy manual and advice on clinical issues. 
Finally, Dr. Petry was at the forefront of efforts for including IGD in the DSM-5. As the primary 
representative to the APA Substance-Related Disorders Workgroup with expertise in behavioral addictions, 
she led the subcommittee on non-substance addictions and wrote the text for this condition that the Board of 
Directors approved and included in the DSM-5 (APA, 2013; Petry & O’Brien, 2013). Dr. Petry also collaborates 
internationally with experts in IGD (Petry et al., 2014, 2015a; Rumpf et al., 2015) and has edited a book (Petry, 
2015). 
Approach
Subjects will be recruited by ads directed at parents, e.g., “Has your child developed problems from playing 
video games too much?” Staff will inform callers that the study involves both parent and child participation. 
Inclusion criteria are: (1) parent/guardian of a 10-19 year old residing in the same household >8 months/year; 
and (2) child meets DSM-5 IGD criteria by self-report or by parent report (see below and Human Subjects). 
Exclusion criteria are parent or child has a significant other mental health condition that may impact response 
to treatment (active suicidality, psychosis), and parent or child is unable to attend 6 sessions over 8 weeks. 
Child age range spans early to late adolescence, and residential criteria ensure the child lives primarily 
with the target parent (allowing for visitation of divorced parents, but not boarding students). The child must 
meet DSM-5 IGD criteria via the self-reported or parent-reported VGDS or semi-structured interview. The self-
report version of the VGDS has established psychometric properties (Rehbein et al., 2015) and we have found 
evidence of validity of the parent-version of the VGDS in our current pilot study, as evidence by concordance 
between the parent VGDS and a clinical interview administered by doctoral level clinicians.  
Informed consent. Persons who call and appear eligible will be invited to an in-person assessment, at which 
we will obtain written informed consent from parents and children aged 18 years; those <18 will provide assent. 
Assessments. Staff will administer instruments with established psychometric properties (when available) to 
assess study entry criteria, hypothesized mechanisms of action, and outcomes. Most measures will be 
collected at baseline (BL), week 4, post-treatment, and a week 24 follow-up. There are some exceptions. The 
demographic interview will be administered at BL only. The AUDIT, DUDIT, BRIEF, BIS-11 (parent and child 
versions), SRS, and the DERS will be administered at BL and post-treatment only. The SCID, TLFB, and the 
T-ASI will be administered at BL, post-treatment, and week 24 only. Abbreviated versions of some measures 
will be administered at the follow-ups. Some variability in the scheduling of the follow-ups will be allowed to 
account for variability between families in how quickly they complete the 6 sessions of therapy.  
Both parents may participate and will complete the parental assessments (est. 2 hours), and both 
(when available) can participate in the therapy, consistent with how family therapy is typically provided. Both 
parents and children will complete a therapy satisfaction form post treatment. Children and parents will receive 
$30 in gift cards for completing the baseline assessment and the 4 week follow-up and $50 in gift cards for the 
post-treatment and 24 week follow-up interviews (up to $160/family member).
Family members may complete their follow-up measures through the survey function of REDCap in 
advance of their in-person meetings. When the research assistant calls to schedule the follow-ups, participants 
will be given the option of receiving the survey link through e-mail, receiving a paper copy of the assessments 
by mail, or completing the measures when they arrive for their in-person meeting. The week 4 assessment can 
be completed in its entirety by the participant at home through REDCap or the mail, unless the participant 
prefers an in-person meeting. Study visits may be completed over the phone if needed. 
Parents will provide: 

basic demographics, including age, SES, gender, and education of parents and child, and indices of the 
child’s school functioning: grades, tardiness, absences and disciplinary issues
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
modified Treatment Service Review (TSR; McLellan et al., 1992) questionnaires about histories and 
current treatments received (of the child). Additional questions specific to treatment for video game 
addiction treatment will be administered at all time points. 

Parents will provide data about their own psychological symptoms (Brief Symptom Inventory [BSI]; 
Derogatis, 1992) 

emotional regulation (Difficulties in Emotion Regulation Scale [DERS]; Gratz & Roemer, 2004). 

Parents’ perceptions of their child’s gaming will be evaluated by a revised VGDS (Rehbein et al., 2015), 
which includes items about types and locations of all gaming devices in the home and frequencies with 
which they monitor their child’s gaming behaviors.

a semi-structured clinical interview using DSM-5 criteria (SCID; Petry et al., 2014), assessed over past 
year and past 2 months at BL and past 2 months at other time points. 

Parents will complete a TimeLine Follow-Back (TLFB; Sobell & Sobell, 1990) of the child’s gaming, time 
spent watching others play online (e.g., YouTube, Twitch), and sleep

Child’s participation in extracurricular activities will be assessed via a checklist from the Michigan Study 
of Adolescent Life Transitions study (MSALT; Eccles & Barber, 1999)

A modified version of the Parenting Style Index (Steinberg, Lamborn, Dornbusch, & Darling, 1992), 
which includes a checklist of types and frequencies with which they use tangible rewards (money, 
goods) and verbally praise their child 

the Brief Family Assessment Measure (BFAM; Skinner et al., 1995, 2000) 

Perceived Social Support Scale (PSSS; Procidano & Heller, 1983). 

Child Behavior Checklist (CBCL; Achenbach, 2001), an index of child competencies and internalizing 
and externalizing symptoms

Conners’ Parent Rating Scale—Revised (CPRS-R; Conners, 2008), a measure of emotional and 
behavioral problems, including ADHD. 

Parents will assess their own quality of life via the Quality of Life Inventory (QoL: Frisch et al., 1992) 

quality of life of their child using the caregiver version of the Questionnaire for Measuring Health-related 
Quality of Life in Adolescents (KINDL-R; Ravens-Sieberer, 2000). 

AUDIT (Saunders et al., 1993) a brief questionnaire about their own alcohol use  

DUDIT (Hildebrant, 2105) a brief questionnaire about their own substance use 

parent version of the Behavior Rating Inventory of Executive Functioning (BRIEF; Guy et al., 2004) will 
evaluate executive function of their child

the Social Responsiveness Scale, a brief autism spectrum screen (Constantino et al., 2003) 

the Barrett Impulsiveness Scale (BIS-11), a measure of their own impulsivity (Patton, Stanford, & 
Barratt, 1995)
Children will complete parallel instruments: 

VGDS (Rehbein et al., 2015), including items about types and locations of gaming devices in the home,

DSM-5 based clinical interview for IGD (SCID; Petry et al., 2014); 

TLFB of days and durations of play, time spent watching others play online (e.g., YouTube, Twitch), 
and sleep

participation in extracurricular activities via the MSALT assessment (Eccles & Barber, 1999) and school 
functioning. 

A modified version of the Parenting Style Index (Steinberg, Lamborn, Dornbusch, & Darling, 1992), 
which includes a checklist of types and frequencies of tangible rewards (money, goods) and verbal 
praise provided by parents will be administered

indices of social support and family communication including the PSSS

BFAM

Teen Addiction Severity Index (Kaminer et al., 1999); 

Social Phobia and Anxiety Inventory for Children (Beidel et al., 1995); 

Center for Epidemiological Studies-Depressed Mood scale (Radloff, 1977); 

Pittsburgh Sleep Quality Index (Buysse et al., 1989). 

the Youth Self-Report (Achenbach, 1991) of emotional and behavioral problems, 
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
DERS (Gratz & Roemer, 2004), 

quality of life KINDL-adolescent version (Ravens-Sieberer, 2000)

the adolescent version of the Barrett Impulsiveness Scale (BIS-11), a measure of their own impulsivity 
(Patton, Stanford, & Barratt, 1995)
Randomization. After baseline, families will be randomized via a computerized algorithm (Stout et al., 1994) to 
groups below. Groups will be stratified by child age (<15 or over), sex, and parents participating (one vs. both). 
A. Referral for care. Therapists will explain that gaming problems often co-occur with other mental health 
problems, and effective treatment for the latter may reduce gaming as well. Therapists will refer parents to 
local support groups such as Department of Mental Health and Addiction Services and National Association for 
Mental Illness support groups. Adolescents will be referred for appropriate services as well, e.g., depression, 
social anxiety, ADHD, or substance use depending on co-occurring problems. 
B. Referral plus Behavioral therapy will consist of referral for other services plus 6 family sessions (adapted 
from Petry, unpublished; Appendix). In Session 1, therapists will review baseline information, refer for other 
services, and orient participants to treatment. They will remind parents that although they cannot prevent 
playing entirely, they can better understand why and when their child is playing and alter their reactions toward 
it, which may decrease the extent of play and problems. Therapists will describe methods to re-arrange the 
home to better monitor and be less conducive toward playing; this may include altering locations of or 
removing some (or all) gaming devices from the home. Therapists will review a tracking form and instruct 
parents how to and benefits of closely monitoring their child’s playing. Children will be asked to keep their own 
log as well.
Session 2 will focus on goal setting for gaming, ranging from 0 to <12 hrs/week (Council on 
Communications and Media, 2013). It will begin with a review of past weeks’ logs. Therapists will troubleshoot 
difficulties with monitoring and concordance of child and parent logs. They will review patterns of play to 
identify high-risk times and days, and circumstances that may have impacted playing. Therapists will outline 
norms related to game playing and media use in general to guide selection and maintenance of reasonable 
goals. 
In session 3, therapists will review logs and how actual gaming aligned or not with goals. Therapists will 
also introduce the concept of replacing high-risk game playing times with alternate activities. The parent, and 
child, will review a list of recreational activities the child does or may enjoy. At least 2-3 activities will be 
identified to occur at high risk gaming times in the upcoming week. Over the next week, participants will 
continue recording gaming and times in which parents encouraged alternate activities and the child’s 
responses. 
Session 4 will review goals in light of increasing alternate activities, and therapists will introduce the 
concept of rewarding non-game playing behaviors this session. They will outline possible rewards, and parents 
will develop a concrete plan to reward their child for not playing during high-risk times in the next week. 
Session 5 will continue discussions of rewards for non-gaming playing behaviors. Therapists will review 
rewards provided and encourage continued rewarding of non-game playing and other positive behaviors in the 
future. The session will focus on communication styles, and the parent and child will role play assertive 
communication skills, especially as they relate to game playing. 
Session 6 will review progress and discuss long-term goals. Therapists will remind parents to continue 
to monitor play, offer alternatives to play, and reward non-gaming behaviors to prevent relapse. The therapist 
will help parents to problem solve any barriers to successful implementation of the behavior plan.
        
Six sessions will be scheduled about once per week over 8 weeks, allowing for missed or re-scheduled 
sessions. The goal will be to complete 6 sessions over 8 weeks; no reschedules will occur after week 12. 
Sessions may be completed over the phone if needed. 
Study visits and follow-up assessments will be scheduled as described above and we have many 
procedures in place to schedule and complete visits as planned (e.g., collection of contact information, 
reminder calls and cards, etc.). However, some flexibility is required to protect participants from unnecessarily 
limiting study procedures to a specific calendar day. If a participant misses an appointment, research staff will 
attempt to contact and reschedule, but we anticipate late and missed appointments.  
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Training and therapists: Treatment will be conducted by Drs. Zajac, Chang, and a post-doctoral fellow. 
Training and supervision will consist of didactics, role plays and review of audiofiles of role-plays and actual 
sessions. Tapes will be rated for general skills and intended content by a modified Yale Adherence 
Competence Scale (YACS; Carroll et al., 2000). Therapists will begin treating patients once they score good or 
better on YACS items on role plays. Once recruitment begins, we will ask participants to consent for 
audiotaping, although they may participate in the study without taping (see Human subjects). If YACS item 
ratings on tapes fall below a mean of “good,” additional training and supervision will occur.  Drs. Chang and 
Zajac have already met these adherence levels as part of a previous study using the same intervention. Any 
additional therapists will be trained and supervised by either Dr. Zajac or Chang. 
Design considerations:
Why this control condition? We considered other control conditions but elected this one because it allows for 
evaluation of follow-up effects (unlike waitlist conditions), controls for some expectancy effects (unlike no 
treatment controls), and increases ability to ascertain benefits of the behavioral family therapy if they exist. A 
therapist attention control condition is premature in Stage 1 research (Rounsaville et al., 2000), but represents 
an important next step if we note benefits in this pilot trial. 
Why not focus on abstinence? Abstinence from gaming will be encouraged for youth who are willing to 
consider a short- or long-term (or indefinite) goal of no game playing. Although we expect that many parents 
will desire that their child refrain entirely from playing, most children probably will not share this goal. To avoid 
alienating youth in these situations, therapists will review “normal” play (Gentile, 2009) and negotiate 
reasonable limits between parents and youth using recommended guidelines (Council on Communication 
Media, 2013), which may include an initial period of no gaming. Therapists will also encourage parents and 
youth to re-arrange the home environment to be less conducive toward gaming (e.g., removing gaming 
equipment from bedrooms) and to better identify and monitor play (e.g., by setting timers or parental controls) 
especially for devices that can be used for purposes beyond gaming (i.e., computers, smartphones). 
Why this duration? A 6-week intervention allows for coverage of topics thought important for altering gaming 
behavior (Council on Communication Media, 2013). It is long enough to demonstrate change if it is efficacious 
and but not so long that topics will become redundant. It is also within the range of other brief family-based 
therapies (e.g., Coatsworth et al., 2001), and an even shorter 3-week (5 session) family intervention has shown 
promise in decreasing gaming (Han et al., 2012). Given the treatment’s emphasis on developing parenting 
skills, the 6-week protocol allows time between sessions for parents to practice new skills at home and 
problem solve barriers to implementation. If this IGD treatment is efficacious in reducing gaming problems, it is 
likely that best practices will be to integrate it alongside other evidence-based treatments to address co-
occurring substance use and mental health disorders. However, the purpose of the current study is to evaluate 
the feasibility, acceptability, and preliminary effect size for this IGD approach. If parents or children recommend 
more or fewer sessions in the therapy satisfaction questionnaire, subsequent studies can alter the duration.
Data analysis
Enhancing reproducibility. Instruments chosen are reliable and valid, although some gaming specific 
instruments are new, and this study will assess their psychometric properties (see below). Careful training of 
evaluators will precede study initiation, and assessment interviews will be audiotaped and rated for reliability 
when participants agree to taping (see Human Subjects; >90% of participants agree to taping in our trials). 
Evaluators blind to treatment conditions will conduct assessments, and obtaining information from multiple 
sources (parent and child) will allow for assessment of concordance between reports (see below).
Primary aims. We will examine baseline (BL) indices and other services received during treatment using the 
Treatment Service Review, and any differences between groups that relate to outcome can be used as 
covariates in subsequent analyses. Analysis will be conducted on an intent-to-treat basis, using all randomly 
assigned subjects. We will evaluate during treatment (BL to post-treatment) and longer-term (follow-up) effects.
Aim 1: To evaluate the feasibility and acceptability of this intervention, the proportion assigned to the 
intervention who complete all 6 sessions will be examined, as will parent and child ratings of satisfaction. 
Aim 2: To examine the effect size of the intervention on reducing game playing days and durations of 
play, we will analyze TLFB data collected at each assessment period, with the greater report of parent or child 
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used for each day. Hierarchial linear models (HLM; Gibbons et al., 1993; Raudenbush & Byrk, 2002) will 
compare differences between groups over time. HLM is specifically designed for repeated measures designs 
with missing data, allowing for intra-subject serial correlation and unequal variance and covariance structures 
over time by incorporating available trend data for each individual with information on the group from which the 
subject is drawn. Maximum likelihood estimation enables analyses to be performed for the full trial without 
having to drop subjects with incomplete data, and both continuous and dichotomous variables can be 
analyzed. The model will include factors representing group, time, and their interaction, along with any 
important covariates.    
We will also compare proportions of subjects by group who are no longer gaming problematically, i.e., child 
reports no current DSM-5 IGD criteria and/or <5 criteria, and parent confirms no more problems for the most 
conservative approach. Logistic regressions will include important demographics and baseline indices of 
distress and severity of problems in Step 1. Step 2 will add treatment to determine if it adds unique variance in 
predicting outcomes after controlling for baseline indices. 
Power analyses. This pilot is designed to assess feasibility, acceptability, and effect sizes. Thirty subjects per 
group are sufficient to address the former, to estimate effect sizes, and to detect moderately large differences 
of Cohen’s (1988) d = 0.65 with Type I error rate =.05, Type II error rate =.20, and power [1-] = .80. If 
medium or larger effect sizes are noted, a larger randomized trial will be proposed to assess long-term 
efficacy. 
Exploratory aims are to evaluate potential mechanisms of actions of the intervention including: changes in 
number and location of gaming devices in the home, frequency of monitoring child’s game playing (via self 
reports in both groups, and confirmed by completed logs in Group B), child’s participation in alternate activities 
(ACC), and parental rewarding of child behaviors and family communications (PSSS, BFAM scores). Following 
recommendations of Morgenstern and Longabaugh (2000) for assessing mediation, Model 1 examines 
whether the treatments engender differential outcomes on gaming indices (i.e., Aim 2 above). Model 2 will test 
if potential mediators change differentially over time by condition. For these analyses, a composite indicator for 
each construct will be utilized (e.g., summary scores of number/location of gaming devices, monitoring 
frequencies, ACC, PSS and BFAM scores). Model 3 will examine partial correlations between post-treatment 
scores on these indices and gaming outcomes, after controlling for baseline scores. If these three models 
show significant effects, the final model will assess associations between these variables and gaming 
outcomes. Step 1 of this model will include baseline scores of the potential mediator(s). In step 2, treatment 
group will be entered, and in step 3, post-treatment scores of the mediator(s) will be included, and resulting 
predictive power of treatment condition examined. If treatment is no longer significant and the post-treatment 
mediation term is significant, criteria for full mediation are met. Although we do not expect to find full mediation 
with this sample size, potential mediators with medium or higher effect sizes in Models 2-3 will be considered 
for future evaluation and inclusion in this intervention, if main effects of treatment are noted (Aim 2). 
We will also assess effect sizes on secondary outcomes, e.g., substance use, psychosocial functioning 
and symptoms, sleep, and quality of life. HLM, outlined above, will compare groups over time on these indices. 
Finally, we will evaluate the psychometric properties of a semi-structured diagnostic interview based on 
the DSM-5 IGD criteria as well as the parent version of the VGDS. Briefly, internal reliabilities of symptoms and 
diagnostic criteria will be calculated using Cronbach’s alpha. Parent and child reports on self-report and 
interviews will be compared using Shrout and Fleiss intraclass correlations for continuous variables and 
Kappa's for diagnostic assessments, with respect to endorsement of specific criteria and diagnosis. For both 
parent and child versions, we will also examine correlations with TLFB gaming behavior and other indices as 
we did previously (Rehbein et al., 2015) to determine convergent validity. Thus, this project allows for initial 
psychometric evaluation of a parent report measure and a structured clinical interview for IGD in youth. 
Future directions. This study will inform future research and treatment for IGD. In terms of assessment and 
diagnosis, psychometrically robust assessment tools are critically needed for research in epidemiological and 
clinical samples, and this study is a step toward developing and validating such tools. 
In terms of treatment, if the intervention is feasible and acceptable and leads to changes in gaming 
beyond that of the control condition, we will propose a larger scale, longer-term study. We can modify the 
intervention based on experiences by removing unhelpful sessions, and adding to those that appear to lead to 
clinically important changes and that show promise for mediating changes in gaming. Even in the absence of 
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treatment-specific effects, these results will provide valuable information about how gaming and psychosocial 
functioning change over time. Given increasing scientific, clinical, and public interest in this condition, this study 
is timely and critical for addressing diagnostic and clinical concerns related to this new “addictive disorder.”
Human Subjects
1.
RISKS TO THE SUBJECTS
a.
Human Subjects Involvement and Characteristics.
i.Inclusion Criteria.
Subjects will be 60 parents/guardians and their children. The inclusion criteria for the families 
are: the parent is the legal guardian of a 10-19 year old residing in the same household >8 
months/year with the child, and the child meets DSM-5 IGD (APA, 2013) criteria by parent or child 
report. 
This age range for children spans early to late adolescence. Although we considered including 
younger or older children, interventions may differ substantially for children at more extreme ends of 
the age spectrum. In particular, younger children may benefit more from complete removal of gaming 
devices as they may not need them for school work assignments, and older children will be less likely 
to be living with parents and thereby may not benefit from an intervention aimed at both parents and 
children. The proposed age range spans that which will be most likely to benefit from a family 
intervention. 
The residential criterion ensures that the child lives primarily with the participating parent so that 
changes in the parent’s behaviors are more likely to impact the child’s gaming behaviors. This 
criterion allows for regular and frequent visitation of children to homes of divorced parents. However, 
if custody is equally split between parents and only one participates in the intervention, then changes 
in one parent’s behaviors are going to be less likely to impact changes in gaming behaviors than if the 
child resides the majority of the time with the participating parent. This living requirement also 
ensures that the child resides with the parent most of the year, because children boarding away at 
schools, for example, will be less likely to benefit from this intervention than those who reside 
primarily with their participating parent(s). When two parents/guardians are available, both will be 
encouraged to participate in the treatment, but to enhance generalization of the interventions we felt it 
impractical to mandate participation of both parents/guardians.
Gaming will be defined by playing video games on any electronic device including computers, 
smartphones, televisions, tablets, and gaming consoles or handheld devices (Xbox, Nintendo, Wii, 
etc). Consistent with the DSM-5 description of IGD (APA, 2103), the gaming need not be over the 
Internet, but the vast majority of individuals with IGD play primarily Internet-based games (e.g., 
Rehbein et al., 2010). Responses from the child or parent that indicate the child meets DSM-5 criteria 
for IGD via the VGDS or semi-structured interview of DSM-5 criteria will qualify the family for study 
participation because best methods for diagnosis are not yet well established. The DSM-5 criteria 
(APA, 2103; Ko et al., 2014; Petry et al., 2014) and the VGDS (Rehbein et al., 2015) have some 
established psychometric properties. These criteria allow for a broad range of participation and mirror 
issues present when families present for treatment, while still ensuring sufficient homogeneity in the 
sample that clinically significant harms have arisen from gaming. 
   ii. Exclusion Criteria. 
Participants will be excluded if parent or child has a significant major other mental health 
condition that may impact response to treatment (including but not limited to active suicidality, 
psychosis, bipolar disorder), or parent or child is unable to attend 6 weekly sessions over 8 weeks.
Individuals with major acute psychiatric illnesses that may impact ability to participate in the 
study may not participate. Anyone with active suicidal intentions, psychosis, or bipolar symptoms, for 
example, will be referred for appropriate psychiatric care. If symptoms subside and patients are 
receiving appropriate psychiatric care, they may be reconsidered for participation in this study when 
stable. Parents or children with other mental disorders (substance use disorders, depression, anxiety, 
attention deficit hyperactivity disorder) may participate, as these other conditions are common among 
those with IGD. Participants will be referred for treatment of these conditions as indicated. Receipt of 
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other mental health treatment before and during the study period will be documented in the Treatment 
Services Review, and any differences in mental health services that occur between groups and relate 
to outcomes can be controlled in analyses. 
If either parent or child is unable to attend sessions regularly over the next two months, they 
cannot participate, or will be reassessed for eligibility after returning from extended vacations or while 
away. 
   
iii. Ineligible Patients.
Some patients will choose not to enroll or will not qualify for this study. They will be referred to
other facilities (e.g., other substance abuse treatment clinics or detoxification services, mental health
treatment facilities) as appropriate.
iv. Treatment Clinics, Services, and Patient Population.
Patients will be recruited primarily from advertisements and word of mouth referrals directed at 
parents in the greater Hartford, CT, area, e.g., ““Worried about how much your child plays video 
games?” We have successfully recruited hundreds of persons with gambling disorder, a disorder with 
a lower base rate than IGD, into clinical trials using similar techniques (e.g., Petry et al., 2006). The 
study team will ensure that the opportunity to participate in this project is made maximally available to 
populations at-risk for Internet gaming disorder. To do this, we will systematically distribute flyers and 
place ads widely to ensure that we are not over-sampling from a single population. For example, we 
will share our flyers with school counselors in both affluent and disadvantaged areas and run ads in 
local papers and on radio stations that have wide distribution areas. Past research indicates that 
males will likely be overrepresented in our sample, and less is known about the prevalence of IGD in 
different racial/ethnic and socioeconomic groups. However, we will regularly (i.e., after every 10 
participants recruited) evaluate the distribution of gender, race/ethnicity, and socioeconomic status of 
our sample and make adjustments to our recruitment efforts based on these results. 
We will also advertise the study at health fairs and at local programs that provide adolescent 
substance abuse prevention and intervention and at schools. 
Treatment will be provided at the University of Connecticut School of Medicine, located just 
outside of Hartford, CT, with easy access by highway and bus lines to local communities. Given the 
lack of any specific treatment for IGD in this densely populated region, we anticipate no difficulties 
recruiting 60 families into this study. 
b. Sources of Materials.  Research material includes parent and child self reports from interviews, 
questionnaires, and observation of patients by study staff.  None of these materials will be available to 
legal, educational, or employer representatives. Data obtained for research purposes will be at no cost 
to patients. 
c. Potential Risks.  Risks associated with participation in this research study include:
i.
Disappointment if not assigned to one’s preferred treatment group;
ii.
Discomfort from being asked questions about gaming, alcohol and drug use, and psychosocial 
problems;
iii.
For those assigned to the brief family behavioral intervention, standard discomforts associated 
with participating in family therapy, including disagreement or discord. 
iv.
Potential breach of confidentiality.
v.
For those assigned to the brief family behavioral intervention, potential discovery of illegal 
behaviors on the part of the youth due to increased parental monitoring of Internet activity.
2.
ADEQUACY OF PROTECTION AGAINST RISKS
a.
Recruitment and Informed Consent.
Informed Consent: A trained research staff member (Bachelors level or above), under supervision of the PI, 
will obtain informed consent. All potential subjects will receive an explanation of this study protocol, its 
potential risks and benefits, and alternative treatment available.  Following resolution of any questions, 
parents/guardians and adult children (i.e., age 18) who agree to participate will be asked to sign the study 
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consent form and HIPAA document.  A signed copy of the consent and HIPAA forms will be given to each 
participant.  Assent will be obtained from children under the age of 18, and both child and parent must 
agree to participate prior to collection of study data or randomization to a condition. As noted above, 
individuals who choose not to participate or who are deemed ineligible will be referred for other services as 
indicated. 
An audiotaping section within the consent form will be utilized for recording of interactions between 
research staff and study patients, including baseline and follow-up interviews and therapy sessions. These 
audiofiles are utilized only for quality control procedures, to rate staff according to set standards in 
interview and treatment administration. Patients may participate in the study even if they do not choose to 
allow audiotaping (in our prior and ongoing studies, less than 5% of patients refuse audiotaping, and in this 
case both child and parent must agree or taping will not occur). The audiotaping consent section will 
explain that the purpose is to rate the staff member’s interviewing and treatment administration skills.
b. Protection Against Risks.  The following will protect against potential risks:
i.
Random group assignment is used, and about half of families will be assigned to the referral alone 
condition and half to the referral plus brief family behavioral therapy condition. These proportions will be 
outlined in the informed consent form, and patients will be made aware that they have about a 50% 
chance of being assigned to the family behavioral therapy condition. Patients may voluntarily end study 
participation if they are dissatisfied with their assignment.
ii.
The interviews and sample collections are brief, patients may skip questions or take a break if 
uncomfortable, and the particular instruments chosen are intended to minimize discomfort.
iii.
A trained and supervised doctoral level therapist will deliver the intervention. Discord or disagreements 
between children and parents will be addressed in therapy, and one full session of the treatment is 
devoted toward improving communication skills. 
iv.
All data will be coded by number, not name, and a "key" form will be kept in a separate locked file 
cabinet.  No information will be provided about the patients enrolled in this study to anyone outside of 
the clinical and research teams, except in emergency situations (e.g., patient deemed a threat to 
him/herself or others) or as required by law (e.g., child abuse/neglect). The study therapists are all 
doctoral level with substantial experience handling crises. If a therapist learns of potential 
abuse/neglect, they will notify the Connecticut Department of Children and Families (DCF) as required 
by law. If a therapist has concerns about potential suicidal or homicidal ideation, the therapist will 
conduct a comprehensive risk assessment and, if deemed necessary, the participant will be transported 
immediately to the emergency room for acute evaluation and treatment. Within the research context, 
research assistants may also hear indications of risk of harm to self or others or abuse/neglect. RAs will 
be well-trained on how to handle these situations. Specifically, the RA will immediately contact the PI, 
study coordinator, or study therapist who will assess safety and manage the crisis directly or instruct 
the RA on how to address risk, including (if necessary) arranging for transportation to an emergency 
room or reporting concerns about abuse or neglect to DCF. 
Audio data will be collected digitally, will be stored on a password protected secure server, and 
destroyed at the end of the study; only research personnel will review the audio files for training, 
supervision, and adherence monitoring purposes. As noted earlier, an audiotaping section within the 
consent form will be used in the study, and patients may participate in the study without allowing 
audiotaping. All audio files will be labeled by number, not name, and the “key” form will be kept 
separate in a locked file cabinet.
v.
It is possible that the increased monitoring of Internet activity that is part of the behavioral treatment 
may lead to uncovering illegal Internet activity on the part of the youth. During the informed consent 
procedure, youth and parents will be informed of this risk. It will also be made clear to the parents and 
youth that any information disclosed to the research team that indicates that the patient is a threat to 
him/herself or others will be reported as required by law to the Connecticut Department of Children and 
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Families (DCF). See 2biv above for details. It is possible that other behaviors (e.g., buying/selling 
drugs, gambling) that are illegal but do not require mandated reporting may be uncovered by increased 
parental monitoring. Although these situations do not represent a threat to confidentiality, they may lead 
to loss of the patient’s privacy and could cause increased conflict in the parent-child relationship. This 
risk is similar to that in adolescent substance abuse treatment, when parents are encouraged to 
increase monitoring through random urine drug screens and room searches. This risk will be mitigated 
by 1) as noted above, informing both parent and youth about this potential risk as part of the informed 
consent procedure; 2) closely following mandated reporting laws in handling this information; 3) 
teaching skills in treatment (e.g., communication) that can help parents and youth negotiate conflict 
situations; and 4) provision of individualized referrals to help address any conflict or symptoms that 
persist. Of note, these risks are similar to those that would occur in outpatient family-based treatment in 
the community, which commonly focuses on increased parental monitoring and supervision of 
children’s behaviors.
c.
Potential Benefits of the Proposed Research to the Subjects and Others.  
The anticipated benefits to participants in the study include careful evaluation of the child’s game 
playing, substance use and psychosocial and family functioning, and a potential for reducing their game 
playing. Parents and children will each receive $30 in gift cards for the intake and 4 week follow-up and 
$50 for the post-treatment and 4-month follow-ups. Total compensation is up to $160 per family member. 
Benefits to society include a potential improvement in the effectiveness of treatment for Internet gaming 
disorder.
d.
Importance of the Knowledge to be Gained. The potential risks of these treatments are minor compared to 
the risk incurred by Internet gaming disorder. The risk/benefit ratio appears favorable.
Detailed Data and Safety Monitoring Plan
1. Brief description of the protocol: This study will be one of the first clinical trials examining the efficacy of a 
brief family-based intervention for Internet gaming disorder (IGD), which has been introduced as a Substance-
Related and Addictive Disorder in Section 3, Conditions for Further Study, in the fifth edition of the Diagnostic 
and Statistical Manual for Mental Disorders (DSM-5). This psychotherapy development study will evaluate 
feasibility, acceptability, and effect sizes of a behavioral intervention designed to help parents reduce gaming 
problems in their children. Sixty concerned parents and their children will complete parental and self-report 
inventories and structured diagnostic interviews regarding the child’s gaming behaviors, substance use and 
psychosocial functioning. Participants will be randomized to either a control condition consisting of referral for 
mental health issues and family support services or to the same plus a 6-week family-based behavioral 
intervention designed to assist with better monitoring and regulating the child’s game playing behaviors and 
encouraging and rewarding alternatives to game playing. Gaming and other problems will be assessed pre-
treatment, mid-treatment, at the end of treatment, and at a 4-month follow-up. This study is unique in 
evaluating initial psychometric properties of a parental version of a measure that uses the DSM-5 criteria for 
IGD in a clinical sample, and it will also assess associations of IGD with substance use, psychological 
symptoms, and family functioning over time. Most importantly, this study will be the first randomized trial of an 
intervention designed to reduce gaming problems, and results are likely to guide future research and treatment 
efforts related to this condition.
2. Primary and secondary outcome measures: Primary dependent variables are: a) feasibility of the 
intervention as evidenced by the proportion of patients assigned to the intervention who complete all 6 
sessions as well as parent and child ratings of satisfaction and b) number of game playing days and durations 
of play. Secondary analyses will examine proportions of subjects by group who no longer meet diagnostic 
criteria for IGD, substance use, psychosocial functioning and symptoms, sleep, and quality of life.
3. Inclusion/exclusion criteria. Study inclusion criteria are: (1) parent/guardian of a 10-19 year old residing in 
the same household >8 months/year; and (2) child meets DSM-5 IGD criteria by self-report or parent report.
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Exclusion criteria are: (1) parent or child has a significant other mental health condition that may impact 
response to treatment (active suicidality, psychosis), and (2) parent or child is unable to attend 6 sessions over 
8 weeks. Only minimal exclusion criteria will be used to ensure that the sample is as representative of 
adolescents with IGD as possible. Because autism spectrum disorders, attention deficit/hyperactivity disorder, 
and other learning or developmental disorder conditions are common among adolescents with IGD, individuals 
with these conditions will 
not be excluded unless their disorder is so severe that it is likely to impact their ability to participate in the 
treatment. 
4.  Sample size. Participants will be sixty parents and their children. This pilot is designed to assess feasibility, 
acceptability, and effect sizes. Thirty subjects per group are sufficient to address the former, to estimate effect 
sizes, and to detect moderately large differences of Cohen’s (1988) d = 0.65 with Type I error rate α =.05, Type 
II error rate β =.20, and power [1- ß] = .80. If medium or larger effect sizes are noted, a larger randomized trial 
will be proposed to assess long-term efficacy.
5. List of participating enrolling clinics. Patients will be recruited from the greater Hartford, CT area. 
Treatment will be provided at the University of Connecticut School of Medicine and other community sites if 
transportation becomes a barrier.
6. Projected timetable. Project start-up, including programming the interviews in the REDCap system and 
training of a research assistant and study therapists, will occur during the first month following receipt of the 
award. In addition, initial review of the therapy manual by the consultants will occur during month 1. 
Recruitment efforts will begin in month 2 and continue through month 18 of the award. The final participants 
will be recruited in month 18 to allow for the 4 month follow-up and for data analysis and manuscript 
preparation. 
7. Target population distribution (e.g., women, minorities, etc). IGD primarily affects 
adolescent males. Thus, we expect that males will be overrepresented among the children participating in the 
study. We expect to recruit both mothers and fathers, but we expect that mothers will participate in the study 
more often than fathers will. Less is known about the prevalence of IGD in different racial/ethnic and 
socioeconomic groups. The study team will ensure that the opportunity to participate in this project is made 
maximally available to populations at-risk for IGD. To do this, we will systematically distribute flyers and place 
ads widely to ensure that we are not over-sampling from a single population. For example, we will share our 
flyers with school counselors in both affluent and disadvantaged areas and run ads on the Internet, in local 
papers and on radio stations that have wide distribution areas. 
8. Data acquisition and transmission. Instruments chosen are reliable and valid, although some gaming 
specific instruments are new, and this study will assess their psychometric properties. Careful training of 
evaluators will precede study initiation, and assessment interviews will be audiotaped and rated for reliability 
when participants agree to taping (see Human Subjects; >90% of participants agree to taping in our trials). 
Evaluators blind to treatment conditions will conduct assessments, and obtaining information from multiple 
sources (parent and child) will allow for assessment of concordance between reports (see below).
9. Data entry methods. Procedures for data processing, management, and analysis are developed and 
refined. Interviews will be administered by a trained research assistant, who will enter data via a laptop 
computer using REDCap, a secure online data entry platform. The interview is programmed to check data at 
the time of entry to ensure that entered values are within the specified range and that items are not 
inappropriately skipped. 
10. Data analysis plan. We will examine baseline (BL) indices and other services received during treatment 
using the Treatment Service Review, and any differences between groups that relate to outcome can be used 
as covariates in subsequent analyses. Analysis will be conducted on an intent-to-treat basis, using all randomly 
assigned subjects. We will evaluate during treatment (BL to post-treatment) and longer-term (follow-up) effects.
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Aim 1: To evaluate the feasibility and acceptability of this intervention, the proportion assigned to the 
intervention who complete all 6 sessions will be examined, as will parent and child ratings of satisfaction. 
Aim 2: To examine the effect size of the intervention on reducing game playing days and durations of 
play, we will analyze TLFB data collected at each assessment period, with the greater report of parent or child 
used for each day. Hierarchial linear models (HLM; Gibbons et al., 1993; Raudenbush & Byrk, 2002) will 
compare differences between groups over time. HLM is specifically designed for repeated measures designs 
with missing data, allowing for intra-subject serial correlation and unequal variance and covariance structures 
over time by incorporating available trend data for each individual with information on the group from which the 
subject is drawn. Maximum likelihood estimation enables analyses to be performed for the full trial without 
having to drop subjects with incomplete data, and both continuous and dichotomous variables can be 
analyzed. The model will include factors representing group, time, and their interaction, along with any 
important covariates.    
We will also compare proportions of subjects by group who are no longer gaming problematically, i.e., 
child reports no current DSM-5 IGD criteria and/or <5 criteria, and parent confirms no more problems for the 
most conservative approach. Logistic regressions will include important demographics and baseline indices of 
distress and severity of problems in Step 1. Step 2 will add treatment to determine if it adds unique variance in 
predicting outcomes after controlling for baseline indices. See section 4 above for power analysis.
Exploratory aims are to evaluate potential mechanisms of actions of the intervention including: changes 
in number and location of gaming devices in the home, frequency of monitoring child’s game playing (via self 
reports in both groups, and confirmed by completed logs in Group B), child’s participation in alternate activities 
(ACC), and parental rewarding of child behaviors and family communications (PSSS, BFAM scores). Following 
recommendations of Morgenstern and Longabaugh (2000) for assessing mediation, Model 1 examines 
whether the treatments engender differential outcomes on gaming indices (i.e., Aim 2 above). Model 2 will test 
if potential mediators change differentially over time by condition. For these analyses, a composite indicator for 
each construct will be utilized (e.g., summary scores of number/location of gaming devices, monitoring 
frequencies, ACC, PSS and BFAM scores). Model 3 will examine partial correlations between post-treatment 
scores on these indices and gaming outcomes, after controlling for baseline scores. If these three models 
show significant effects, the final model will assess associations between these variables and gaming 
outcomes. Step 1 of this model will include baseline scores of the potential mediator(s). In step 2, treatment 
group will be entered, and in step 3, post-treatment scores of the mediator(s) will be included, and resulting 
predictive power of treatment condition examined. If treatment is no longer significant and the post-treatment 
mediation term is significant, criteria for full mediation are met. Although we do not expect to find full mediation 
with this sample size, potential mediators with medium or higher effect sizes in Models 2-3 will be considered 
for future evaluation and inclusion in this intervention, if main effects of treatment are noted (Aim 2). 
We will also assess effect sizes on secondary outcomes, e.g., substance use, psychosocial functioning 
and symptoms, sleep, and quality of life. HLM, outlined above, will compare groups over time on these indices. 
Finally, we will evaluate the psychometric properties of a semi-structured diagnostic interview based on 
the DSM-5 IGD criteria as well as the parent version of the VGDS. Briefly, internal reliabilities of symptoms and 
diagnostic criteria will be calculated using Cronbach’s alpha. Parent and child reports on self-report and 
interviews will be compared using Shrout and Fleiss intraclass correlations for continuous variables and 
Kappa's for diagnostic assessments, with respect to endorsement of specific criteria and diagnosis. For both 
parent and child versions, we will also examine correlations with TLFB gaming behavior and other indices as 
we did previously (Rehbein et al., 2015) to determine convergent validity. Thus, this project allows for initial 
psychometric evaluation of a parent report measure and a structured clinical interview for IGD in youth.
11. Quality assurance plan: All research staff will be thoroughly trained and supervised regarding 
administration of interviews and completion of all necessary forms. Some measures will be entered directly into 
REDcap, an online data entry system that allows for direct input of data. REDCap allows for restriction of 
response values to insure that responses entered are valid and fall within the specified range. REDCap also 
prompts interviewers if responses are missing, thus greatly improving the accuracy of data collection. Finally, 
REDCap allows for direct download of complete data into a variety of software programs, including Excel and 
SPSS.
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In addition, the project coordinator reviews at least 5% of the entered data for accuracy. Research 
assistants regularly audio-record their research interviews, and the project coordinator or other study staff 
listens to these recordings to insure accuracy of administration of interviews and recording of data in REDcap. 
If any specific variables are found to be consistently problematic, the project manager and research assistant 
will implement a specific training action plan to resolve the problem. The project manager is responsible for 
study documentation, including data correction and electronic data files. Prior to the conduct of the final 
analyses, the raw data will undergo extensive examination by the PI or project coordinator. 
12. Reporting mechanisms of AEs/SAEs to the IRB, FDA, and NIDA. Types of SAEs in this population are 
as follows: (a) onset of clinically significant suicidal ideation, intent or action; (b) onset of clinically significant 
homicidal ideation, intent or action; (c) deterioration of mental status to an extent that requires inpatient 
hospitalization or overnight stay at an acute treatment facility. All SAEs will result in the completion of an SAE 
Form within 48 hours to the Project Coordinator. Deaths and possibly study related SAEs will be reported 
immediately to the PI and within 72 business hours to the NIH project officer. We will follow our IRB’s standard 
policy on reporting of SAEs, which is to report all serious, unexpected related to possibly related AEs to the 
IRB within 5 working days.
An Adverse Events Monitoring Form will be adapted from one being used in our ongoing trials. This form 
collects detailed information about all adverse events, how they were handled, and their potential relationship 
to study participation. The procedures for SAE reporting also include written documentation using the clinical 
notes related to the adverse event and specific forms detailing the event with a sign-off by appropriate 
supervisory personnel.
Other adverse events, such as suicidal ideation that does not require hospitalization, will also be recorded 
on an Adverse Events Monitoring Form. Clinically significant increases in gaming or other problems detected at 
follow-ups will result in referrals for further treatment. 
An ongoing database of adverse events will be maintained by the study coordinator. About once per 
month, in research team meetings, all events that occurred in the previous month will be reviewed. In addition 
and according to university policy, the local IRB maintains records of adverse events, and records are sent to 
NIH per policy. Aggregate data on reports of adverse events are reviewed on at least an annual basis by the 
IRB for study continuation according to their established policies. Any temporary or permanent suspension of 
patient accrual will also be reported to NIH. We anticipate that unexpected and possibly study-related SAE’s 
will be rare, because patients will be receiving a psychosocial intervention.
13. Reporting mechanism of IRB actions to NIDA. The PI will be responsible for informing NIDA of any 
actions taken by the Institutional Review Board as a result of its regular or special reviews of the project. 
14. Report of changes or amendments to the protocol. The PI will receive approval from the NIDA project 
officer prior to making any major changes to the study protocol (unless there is an immediate safety concern) 
and also provide timely reporting to the NIDA Project Officer of any changes in the IRB approval status, and 
other major problems or issues that could have a significant impact on participants. 
15. Trial stopping rules. A decision to discontinue the study will be based primarily on serious 
adverse events (SAEs). The study will be stopped if unexpected and possibly study-related SAEs occur in 15% 
or more of the study sample or the trial appears futile to continue (e.g., unacceptably high rates of study refusal 
or withdrawals).
16. Conflict of interest. The PI and the research team do not have any conflicts of interest to report. 
17. Potential risks and benefits for participants. The risks associated with participation in this research 
study are minimal but include: (1) disappointment if not assigned to one’s preferred treatment group; (2) 
discomfort from being asked questions about gaming, alcohol and drug use, and psychosocial problems; (3) 
for those assigned to the brief family behavioral intervention, standard discomforts associated with participating 
in family therapy, including disagreement or discord. (4) potential breach of confidentiality; and (5) for those 
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assigned to the brief family behavioral intervention, potential discovery of illegal behaviors on the part of the 
youth due to increased parental monitoring of Internet activity.
The following will protect against potential risks:
(A) Random group assignment is used, and about half of families will be assigned to the referral alone 
condition and half to the referral plus brief family behavioral therapy condition. These proportions will be 
outlined in the informed consent form, and patients will be made aware that they have about a 50% chance of 
being assigned to the family behavioral therapy condition. Patients may voluntarily end study participation if 
they are dissatisfied with their assignment.
(B) The interviews and sample collections are brief, patients may skip questions or take a break if 
uncomfortable, and the particular instruments chosen are intended to minimize discomfort.
(C) A trained and supervised doctoral level therapist will deliver the intervention. Discord or disagreements 
between children and parents will be addressed in therapy, and one full session of the treatment is devoted to 
improving communication skills. 
(D) All data will be coded by number, not name, and a "key" form will be kept in a separate locked file cabinet.  
No information will be provided about the patients enrolled in this study to anyone outside of the clinical and 
research teams, except in emergency situations (e.g., patient deemed a threat to him/herself or others) or as 
required by law (e.g., child abuse/neglect). The study therapists are all doctoral level with substantial 
experience handling crises. If a therapist learns of potential abuse/neglect, they will notify the Connecticut 
Department of Children and Families (DCF) as required by law. If a therapist has concerns about potential 
suicidal or homicidal ideation, the therapist will conduct a comprehensive risk assessment and, if deemed 
necessary, the participant will be transported immediately to the emergency room for acute evaluation and 
treatment. Within the research context, research assistants may also hear indications of risk of harm to self or 
others or abuse/neglect. RAs will be well-trained on how to handle these situations. Specifically, the RA will 
immediately contact the PI, study coordinator, or study therapist who will assess safety and manage the crisis 
directly or instruct the RA on how to address risk, including (if necessary) arranging for transportation to an 
emergency room or reporting concerns about abuse or neglect to DCF. 
All audiorecordings will be stored digitally on a password protected secure server and destroyed at the 
end of the study; only research personnel will review the recordings for training, supervision, and adherence 
monitoring purposes. An audiorecording section within the consent form will be used in the study, and patients 
may participate in the study without allowing audiorecording. All audio files will be labeled by number, not 
name, and the “key” form will be kept separate in a locked file cabinet.
(E) It is possible that the increased monitoring of Internet activity that is part of the behavioral treatment may 
lead to uncovering illegal Internet activity on the part of the youth. During the informed consent procedure, 
youth and parents will be informed of this risk. It will also be made clear to the parents and youth that any 
information disclosed to the research team that indicates that the patient is a threat to him/herself or others will 
be reported as required by law to the Connecticut Department of Children and Families (DCF). See 17D above 
for details. It is possible that other behaviors (e.g., buying/selling drugs, gambling) that are illegal but do not 
require mandated reporting may be uncovered by increased parental monitoring. Although these situations do 
not represent a threat to confidentiality, they may lead to loss of the patient’s privacy and could cause 
increased conflict in the parent-child relationship. This risk is similar to that in adolescent substance abuse 
treatment, when parents are encouraged to increase monitoring through random urine drug screens and room 
searches. This risk will be mitigated by 1) as noted above, informing both parent and youth about this potential 
risk as part of the informed consent procedure; 2) closely following mandated reporting laws in handling this 
information; 3) teaching skills in treatment (e.g., communication) that can help parents and youth negotiate 
conflict situations; and 4) provision of individualized referrals to help address any conflict or symptoms that 
persist. Of note, these risks are similar to those that would occur in outpatient family-based treatment in the 
community, which commonly focuses on increased parental monitoring and supervision of children’s 
behaviors.
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18. Collection and reporting of SAEs.  See Section 12.  
19. Management of SAEs or other study risks. As noted above, SAEs will be documented and reported on a 
regular basis to the project director, the PI, the IRB, and NIDA as indicated. Discussions of SAEs will occur 
during monthly meetings between the study staff and the PI will be available to have more frequent meetings 
about SAE reporting as needed. During the monthly meetings, the PI and research staff will examine and 
discuss any SAEs and AEs over the past month as well as patterns of AEs and SAEs that have occurred over 
the course of the study. Other information related to study risks, including retention data and any participant 
complaints, will also be reviewed and discussed during these meetings. This information will guide decision 
making about whether recruitment should continue unchanged, whether a protocol amendment is needed to 
mitigate risks, or whether recruitment needs to be stopped pending further investigation. If the study needs to 
be stopped due to safety concerns, the IRB and NIDA will be promptly informed within 72 hours.  
20. Plans for interim analysis of efficacy data. Because sample size is relatively modest (i.e., effect sizes 
are unlikely to be large enough to detect differences during interim analyses) and safety risk is quite low, we 
are not planning to conduct a preliminary analysis of accumulating efficacy and safety data by treatment 
assignment.
21. Responsibility for data and safety monitoring. The Principal Investigator, Co-Investigators, other study 
personnel, and the Institutional Review Board (IRB) will provide safety oversight for the project. The PI, Co-Is, 
and study personnel will review safety data about monthly and make any decisions about modifications or 
stoppage of the trial as noted in section 19. The PI will also be responsible for conducting a literature search on 
treatments for IGD annually to identify any findings that might influence study procedures or conduct. The PI 
will report any information related to unanticipated risks or new information that might change the risk-benefit 
ratio to the IRB and NIDA Project Officer. This information may come from the current study or new findings 
from other studies. Any changes in the protocol or consent as a result of this information will be promptly 
reported to the NIDA Project Officer. 
22. Frequency of DSM reviews: The PI meets about monthly will research staff to monitor study progress. 
The informed consent process, fidelity to inclusion and exclusion criteria, and the integrity of the overall data 
and safety monitoring plan are also reviewed in these meetings. Problems identified during monitoring will lead 
to an immediate corrective plan and possible reporting to the IRB and NIDA Project Officer, depending on the 
problem. 
23. Content of DSM Report. Reports will include data that inform progress of the study, including baseline 
demographics, adverse events data, and accrual status. In addition, a database of AEs and SAEs will be 
maintained by the study coordinator. About once per month, in the research team meetings, all adverse events 
will be reviewed that occurred over the prior month, as well as over the course of the trial. In addition, the local 
IRB maintains records of AEs and SAEs. All SAEs are reviewed and records sent to NIDA and the IRB per 
their standard policies. 
A DSM report will be sent to NIDA on an annual basis, at the same time as the Annual Non-Competing 
renewal. The categories include: 1) description of any non-administrative changes in the study protocol; 2) 
baseline sociodemographic characteristics of new enrollees; 3) any new quality assurance problems or 
changes; 4) any new regulatory issues; 5) summary of all AEs/SAEs and any related changes to the consent 
form or study protocol; 6) any significant protocol violations and deviations, and any corrective actions 
undertaken to eliminate future occurrences; and 7) summary of the literature review conducted in the prior year 
to assess for any newly reported risks associated with IGD interventions. 
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