Adolescents With Substance Use Disorders Transitioning From Residential Treatment to the Community: Improving Outcomes Via a Computer Assisted Parenting Program
Phase: NA
Conditions: Substance Use, Adolescent Behavior
Sponsor: Brown University

 
 
 
PROJECT TITLE: 
Adolescents with Substance Use Disorders Transitioning from 
Residential Treatment to the Community: Improving 
Outcomes via a Computer Assisted Parenting Program 
 
PRINCIPAL INVESTIGATOR: 
 
Sara Becker, Ph.D. 
 
 
CLINICALTRIALS.GOV IDENTIFIER:  
NCT03592186 
 
DOCUMENT DATE:  
Created for Brown University IRB October 4, 2018 
 
 
Uploaded to ClinicalTrials.Gov July 2, 2020  
 
 
 
 

 
 
PROJECT TITLE: 
Adolescents with Substance Use Disorders Transitioning from 
Residential Treatment to the Community: Improving Outcomes via 
a Computer Assisted Parenting Program 
 
PRINCIPAL INVESTIGATOR: 
Sara Becker, Ph.D. 
 
 
A. SUMMARY OF PROPOSED PROJECT 
 
Adolescents with substance use disorders (ASUD) in residential treatment have the 
most serious substance use disorders and the highest rates of psychological, motivational, 
behavioral, legal, environmental, and vocational problems. ASUD in residential treatment are 
also at extremely high risk of relapse, with follow-up studies suggesting that 60% of ASUD will 
relapse within the first 90 days of discharge. Parenting practices have been established as a 
key influence on adolescents’ initiation and maintenance of substance use, as well as their 
substance use outcomes and likelihood of relapse. However, therapists who treat ASUD have 
reported a myriad of systemic barriers to engaging parents in treatment. Findings such as these 
deem ASUD in residential treatment a high priority population and argue for the value of easily 
accessible parenting interventions during this critical time. 
 
The proposed study will evaluate one potential low cost, low intensity model for 
delivering parenting skills to parents preparing for their adolescent’s discharge from residential 
substance use treatment. Specifically, this project will adapt the delivery of a computerized 
parenting intervention (Parenting Wisely; PW) that has preliminary evidence of efficacy in 
improving parenting skills and reducing youth behavior problems. PW delivery will be adapted 
for a new population (parents of ASUD preparing for discharge) and new setting (residential 
treatment), and preliminary data will be obtained on its feasibility, acceptability, and 
effectiveness. The open trial has been completed and consisted of recruitment, intervention, 
and assessment procedures with 10 parents to adapt the delivery of PW to include moderate 
engagement strategies relevant to this population. Initial engagement strategies have been 
developed based on focus groups and interviews with 13 parents, 11 ASUD, and three staff 
members and include up to four sessions of individualized coaching that begin prior to 
discharge (incorporated into standing family appointment times) and the use of technology (e.g., 
text messaging and an online parent message board) to maintain contact between staff and 
parents post-discharge.  
 
Use of a low-cost, low-intensity intervention paired with moderate engagement strategies 
represents a marked change from traditional office-based treatment delivery methods. The 
approach has the potential to advance public health by: addressing a high-needs population; 
targeting parenting practices (putative mediators of change) that have been shown to influence 
ASUD outcomes; working with parents during a critical treatment juncture; improving parental 
engagement and access to care, and increasing ease of dissemination and implementation. 

 
 
 
B. APPLICATION/PROPOSAL FOR FUNDING/SUPPORT 
 
The initial grant awarded by the National Institutes on Drug Abuse proposed two phases – an 
open trial and a randomized controlled trial. This protocol pertains only to the randomized 
control trial portion of the study procedures proposed in the funding application at a new site. 
 
Please note the primary difference between the current proposal and the original application. In 
the original application, the target site was Gateway Residential Services (GRS). By the end of 
the study, the facility changed its name to the Caritas ARTS Program. In addition, we added a 
second site after consultation with the Project Officer, both to ensure we met the pre-specified 
recruitment target and to enable us to inform the design of a fully powered trial. The two 
programs are:  
 
Caritas ARTS Program – short term residential facility with 16 beds, average length of stay 6-
10 days  
Rosecrance Health Network – long term residential facility with 80 beds, average length of stay 
30-45 days  
 
C. SPECIFIC AIMS AND DETAILED STUDY METHODOLOGY 
 
1. Specific Aims 
The goal of this pilot study is to adapt the delivery of PW for a new population (parents of ASUD 
preparing for discharge) and new setting (residential treatment), and to obtain initial data on its 
feasibility, acceptability, and effectiveness. The study began with an open trial of 10 parents to 
demonstrate feasibility, acceptability, and preliminary evidence of effectiveness over time. 
Specific research aims of the protocol are: 
 
Aim 1: To examine the feasibility and acceptability of an adapted PW intervention that 
includes moderate engagement strategies for parents of ASUD preparing for 
discharge from residential. 
Hypothesis 1a: Adapted PW will be both feasible and acceptable to parents. Feasibility will be 
indicated by enrollment rates (> 80%) and indicators of parent engagement: attendance 
of > 2 coaching sessions for > 75% of parents, and online usage patterns of 2+ PW 
logins, viewing of video vignettes embed in text messages, 1+ parent board posts. 
Criteria for acceptability will be withdrawal rates (< 20%), > 80% of ratings on a 
consumer satisfaction scale in the highest two categories, and positive feedback from 
exit interviews with parents. 
 
Secondary Aims 2-4: To examine the preliminary effectiveness of the experimental 
intervention on: substance use outcomes, related high-risk behaviors, and 
parenting skills (the putative mediators of change). 
Hypotheses: At baseline, 6-week follow up, 12-week follow up, and 24-week follow-up, the 
experimental intervention will demonstrate superior outcomes, relative to treatment as 
usual on:  
2a: indicators of substance use: substance use frequency, severity of substance use 
symptoms, rates of relapse, and biological markers (i.e., urine drug screens). 
3a: high-risk behaviors commonly related to substance use: externalizing behavior, sexual 
risk behavior, school truancy, and criminal behavior. 
4a: parenting behaviors: parental monitoring and communication, as demonstrated by both 
parent and adolescent report and observed during an in vivo task. 
 

 
 
2. Detailed Study Methodology 
STUDY PURPOSE. We are seeking approval to conduct a randomized control trial of 60 
parents whose adolescents are preparing for discharge from residential substance use 
treatment at a new remote site. The goals of this project are to: (1) examine if the adapted 
intervention and the study assessment procedures are feasible and acceptable to study 
participants; (2) evaluate the preliminary effectiveness of the adapted intervention.  
 
STUDY POPULATION. We are currently seeking approval to enroll 60 parent-adolescent dyads 
(i.e., a total of 12- participants) for a randomized trial. 
 
Inclusion / Exclusion Criteria. Parents must meet the following inclusion criteria: (1) be the 
parent or legal guardian of an adolescent aged 12 years -17 years inclusive, at the start of the 
project; (2) had adolescent admitted to residential treatment facility due to concerns about 
frequency and/or severity of substance use; (3) will be the primary guardian living with the 
adolescent after the adolescent’s discharge from treatment; (4) access to internet and a phone 
that can receive text messages; (5) fluent in English or Spanish; and (6) willing to provide 
written consent and teen willing to provide written assent. Adolescents automatically qualify for 
the study if their parents meet the aforementioned criteria. There are no exclusion criteria for 
participation in this study beyond failure to meet the inclusion criteria. If during the consent or 
assent process, the teen exhibits any conditions or behaviors that would preclude participation 
in the baseline assessment (e.g., mania, psychosis), then the interview will be paused and the 
research staff member conducting the consent / assent process will immediately notify the 
Medical or Clinical Director (Dr. Selby Conrad at Caritas, Dr. Thomas Wright at Rosecrance) at 
the residential facility to ensure adequate clinical assessment of the adolescent. The interview 
will be rescheduled for a time when residential staff has determined that the adolescent can 
participate in an interview. Behaviors that would cause a delay in the interview are expected to 
occur with extreme rarity, as there is no access to substances within the residential center and 
adolescents with acute conditions such as mania and psychosis are typically not admitted to 
the residential center. 
 
Recruitment and Enrollment Procedures. Parents of adolescents receiving residential 
substance use treatment will be referred from the residential center. Parents will be told that a 
research project is currently taking place at the residential facility to test a technology-assisted 
parenting skills intervention and that they can choose to complete a Consent to Contact Form if 
they would like research staff to contact them with additional information. Dr. Becker, a licensed 
clinical psychologist and recipient of the grant award, and/or a hired study Research Assistant, 
Study Assessor/ Postdoctoral Fellow or project staff, will contact parents that complete Consent 
to Contact Forms to provide a brief overview of the study and see if parents would like to 
schedule an informed consent meeting (with sufficient time allocated for the baseline 
assessment if parents decide to participate). One of the aforementioned research team 
members will conduct the informed consent process either in person or via Zoom, using an 
instance specifically recommended by Brown CIS. Parents will provide electronic consent and 
adolescents will provide electronic assent prior to being enrolled in the study. Whenever 
possible, we opt to use electronic assent and consent to reduce risk to adolescents and their 
parents associated with having written consent forms stored at an offsite facility. Once informed 
consent is obtained, an intake assessment will be scheduled at a time that is convenient for the 
family, which could include a time immediately before or during the next family session. 

 
 
Racial/ethnic and gender considerations. Consistent with the primary parent participating in 
treatment in previous research, we expect at least 75% of the parents to be mothers. Prior 
residential treatment research, have demonstrated prevalence rates of approximately 30% girls 
and 70% boys, so we expect a comparable split between boys and girls. Data from the facilities 
has also showed ethnic/racial distribution of approximately 62% White/European American 
families and 38% racial/ethnic minority families, most of whom identified as Hispanic/Latino 
(18%), African-American (7%), or 2+ races (5%). 
 
Retention procedures. At baseline, multiple sources of contact information will be recorded for 
parents and ASUD to prevent attrition. A demographic form will be administered aloud by a 
research staff member at Brown via Zoom and information will be obtained and stored in hard 
copy form in locked filing cabinets in the PI’s office at Brown University. Contact information will 
be updated by periodic phone calls and during assessments. Reminders will be made via phone 
and mail. The PI will hold weekly case review meetings to review no-shows and outreach 
attempts, and discuss plans to complete contact with missing participants. Compensation for 
completion of questionnaires and interviews/discussions escalates slightly from $40 at baseline, 
6 and 12 weeks to $60 at 24 week followThis compensation schedules recognizes the 
increased effort associated with scheduling a follow-up and providing a urine screen after the 
teen has been discharged. We have used these retention procedures (e.g., reminder calls, 
periodic update calls, escalating compensation) with success in current and prior projects. 
 
Randomization. In the randomized pilot trial, parent-adolescent dyads will be randomized to 
the adapted PW condition or to residential treatment as usual using urn randomization balanced 
by biological sex (male vs female), race/ethnicity (White, Non- Hispanic vs Non-White, 
Hispanic), and days of substance use (1-45 vs 45+). Randomization will be done by the 
research staff using a randomization spreadsheet immediately at the end of the baseline 
assessment; condition assignments will then be immediately told to the family. Those assigned 
to the adapted PW condition will be scheduled for their first remote coaching session 
approximately 4 weeks prior to discharge (described below). 
 
Protecting confidentiality. Steps taken to protect the confidentiality of participants are detailed 
in Section D, “Possible Risks and Anticipated Benefits” in the paragraphs focused on 
minimizing risk of loss of confidentiality. 
 
INTERVENTION. Parents and adolescents will begin to receive the PW intervention 
shortly after intake. The residential treatment team works with each adolescent’s family, 
insurance provider, and any auxiliary decision makers (e.g., Child and Protective Services, 
Youth Probation Officers) to devise a preliminary treatment plan and tentative discharge date. 
All adolescents and parents will receive the standard treatment offered by the residential 
facility. In addition, they will receive the additional treatment elements below. 
 
Parenting Wisely (PW). PW is a self-administered, interactive, multimedia online program. PW 
is available in both English and Spanish (Ser Padres Con Sabiduría). In PW, parents view video 
vignettes of ten common family 

 
 
problems (e.g., adolescent substance abuse, curfews, household chores, monitoring of friends, 
sibling conflict, improving in school, getting up on time, sharing technology, etc.). After selecting 
a problem, parents view a video clip depicting a family struggling with that problem. Parents are 
given three possible solutions to the problem to select from, and then receive feedback 
according to the solution they selected. The feedback is presented in a video enactment of their 
selected solution and in an explanation of the pros and cons to each choice. This feedback is a 
critical part of the program, for it points out any errors parents made, explains why ineffective 
solutions lead to problems, and discusses why effective parenting solutions prevent and solve 
common family problems. The main parenting behaviors emphasized by each vignette include: 
1) problem solving; 2) limit setting; 3) praising; 4) effective communication through I-messages 
and active listening; 5) supervision and monitoring, and 6) clear communication of teen’s 
behavioral expectations. The program comes with a parent workbook that outlines all of the 
vignettes included in the program, along with the potential problems and solutions. The 
workbook also contains a glossary of terms, sample behavior charts, and practice exercises, so 
that parents can gain additional practice with the skills. The complete PW program takes from 3 
to 5 hours to complete depending on the users speed and depth of use. Parents will be asked to 
create an unidentifiable login and password at enrollment so that they have the option to 
practice sessions or view any additional sessions at home; parents will then be prompted to 
generate their own password after the first time they login to the system if they would like. As 
discussed in the analysis section, we will use these unique logins to monitor parent participants’ 
usage of PW for analyzing parental engagement. The parent coach will encourage parents to 
complete any sessions at home that they view as relevant to their parenting concerns. Based on 
parent-adolescent discussion task feedback, we recommend 3-4 PW modules to each family. 
We encourage parents to tailor the program to their own needs by watching the sessions that 
apply to them with staff feedback around which sessions may highlight the skills parents are 
seeking to practice. After discharge, parents will be encouraged via text messages and the 
online message board to complete additional sessions. 
 
Individual Coaching Sessions. Individual coaching sessions are designed to individually tailor 
the PW skills to each parent’s presenting concerns. Parents may receive up to 4 sessions by 
the first follow-up assessment (scheduled 6 weeks post discharge). Based on PI Becker’s 
consultation with PW developer Consultant Gordon, we have selected 4 core parenting skills to 
emphasize in the sessions: I-statements, Contracting, Active Listening, Reframing. The initial 
session will be 60-75 minutes and will consist of several sections: 1) Rationale for parenting 
skills, 2) Review of feedback from the baseline in vivo parent-adolescent interaction task in 
order to cater the computerized parenting program to the families’ specific needs 3) Overview of 
four core parenting skills; 4) Review of PW substance use module, and 5) practice applying the 
skill to a current problem. Subsequent sessions will be 45-60 minutes and will follow the same 
basic outline, while introducing the remaining core skills. When parents have questions or 
introduce problems/complaints about their teen, the coach will first provide validation and then 
discuss how the parents’ problems can be addressed using a skill. Parents will be offered 
sessions remotely via phone or video-conference technology.  
 
Text-based messaging. Immediately upon enrollment in the PW condition, parents will receive 
daily text messages for 6 months to reinforce skills from PW, to motivate continued participation 
in PW, and to encourage participation in the online parent message board (described below). 
Parents will be able to choose if they want to receive the text messages in English or Spanish. 
Approximately half of the texts reinforce material taught in PW, along with a link to a video clip 
enacting a core PW skill. For example, a message might contain a simple reminder statement 
about a parenting strategy such as limit- setting, monitoring, and communication with a link to a 
video clip demonstrating this strategy. The second half of all text messages either offer an 
encouragement for the parent to complete more PW sections or an encouragement to 

 
 
participate in the web- and smartphone-based parent message board. These messages will 
contain links to the appropriate website. We intentionally do not propose interactive texting 
because we will direct parents to ask questions via the parent board, which we believe will be 
ultimately more transportable. Nonetheless, this limited application of texting is a potential 
important ingredient to extending parents’ engagement in the parenting skills intervention, 
similar to the use of texting to increase uptake of flu vaccinations and outpatient clinic 
attendance. These text messages will be automated and delivered by an external vendor called 
Silent Disclosure. 
 
Online parent board. Silent Disclosure created a secure project website with two interactive 
message boards for adolescent parenting related questions. The two message boards include: 
1) “Ask an Expert”, in which parents could post a question to a licensed clinical psychologist 
with expertise in adolescent substance use and mental health problems and have their question 
answered within 24-48 hours, and 2) “Connect with Parents”, in which parents can seek social 
support from other parents of adolescents in residential treatment by either posing questions or 
answering questions posed by other parents. This interactive message board can be accessed 
both as a website on a computer or as a phone-based application (similar to the way that other 
popular websites for email, airlines, or networking sites can be viewed in easier to read app 
form). This website was based on http://www.men2menri.org/get-health-facts/ask-r-is-doctor- 
phil-chan/, a model developed by a colleague at Brown University and collaborator of Co-Is 
Spirito and Hernandez. Based on parent feedback in our pilot data, the website includes basic 
substance use and parenting skills information, links to sections of PW, as well as an interactive 
message board. Consistent with our colleague’s approach, all questions submitted will be 
reviewed by the project team to determine suitability for the board and responded to within 24- 
48 hours. Questions posted in English will be answered by PI Becker, while questions posted in 
Spanish will be translated by the bilingual Research Assistant, answered by PI Becker, then 
posted in Spanish by the bilingual Research Assistant. To ensure that all participants can 
contribute and read all of the messages, the website uses Google translate to offer parents the 
opportunity to view content in English or Spanish. A Spanish-speaking bilingual RA reviews the 
translations generated by Google Translate and makes edits to ensure accurate conceptual 
translations prior to approving the messages to the site. At the start of the program, parents will 
be informed that the online message boards are a place to ask parenting related questions and 
not a place to request crisis support. Answers to questions will direct parents to a specific PW 
module(s) most relevant to their parenting question. Parents’ comments will be anonymous and 
will not be visible to others until approved for posting by the team. Participation will be 
encouraged until the final study assessment (24 weeks post-discharge). Each parent selects a 
unique non-identifiable username. Use of a unique login will allow research staff to measure, at 
the individual participant level, the number of logins to access the site, the number of page 
views of others participants’ questions and responses, and frequency of message postings. 
 
THERAPIST TRAINING / SUPERVISION.  
Treatment will be delivered by Bachelor's or Master's-level parent coaches from the Brown 
University research team, one of whom is bilingual in English and Spanish.. All therapists will 
be trained to demonstrate sufficient adherence and competence by PI Becker. As a first 
training step, therapists will be required to review the manual, PW workbook, and modules of 
the PW computerized intervention. The PI and two therapists will then role-play and videotape 
the 4 core sessions. PI Becker will view these role plays, complete measures of therapist 
adherence and competence, and provide brief written summaries. Competency will be rated 
with 6 items that comprise the “General Therapeutic Skills” section of the Cognitive Therapy 
Rating Scale (CTRS), which is routinely used to assess therapist competence in Co-I Spirito’s 
protocols. The CTRS is well suited to assess the in-person coaching sessions, since these 
sessions use a structured, skills- based, and collaborative approach. A score > 24 is the 

 
 
criterion to indicate competence on the 6 item version. PI Becker will calculate a consensus 
CTRS score and provide a synthesis of written feedback to each therapist. Adherence 
measures will be developed in collaboration with Consultant Gordon based on the in-person 
manual. Therapists will be required to earn a satisfactory consensus CTRS score of > 24 on 3 
of 4 role plays and satisfactory adherence ratings to be assigned a participant. 
 
Once the Brown therapists are assigned participants, sessions will be audio recorded and rated 
for competence and adherence. PI Becker will review and rate the first two tapes for adherence 
and competence. If ratings are satisfactory, PI Becker and the post-doctoral fellow will 
collectively review 25% of tapes (i.e., 1 of the 4 remote sessions per client) moving forward. PI 
Becker will meet weekly with therapists for supervision focused on adherence to the protocol, 
therapist skill in protocol delivery, and how to tailor the PW protocol to each parent’s unique 
presenting concerns. 
 
MEASURES. Parents and teens will complete a baseline assessment either immediately after 
providing informed consent / assent or shortly thereafter via phone or video conference by 
Brown University staff. Follow-up measures will also be conducted by phone or video 
conference by Brown University staff at 6, 12, and 24 weeks following the teen’s discharge. The 
baseline assessment will be about 1.5 hours for the adolescent and 1 hour for the parent and 
the follow-up assessments will be about 1.5 hours for both the adolescent and parent. Parents 
and adolescents have been able to complete assessments of this length or longer in our team’s 
prior and current studies. 
 
The measures used in this study are outlined below. Based on our team’s experience working 
with 100s of families on clinical research projects in Rhode Island, we have decided to translate 
all of the parent measures into Spanish. We retain all of the adolescent measures in English. It 
is well established that adolescents tend to acculturate to the U.S. culture more quickly than 
their parents, and we have found that adolescents in our studies from Spanish-speaking families 
are typically comfortable speaking and completely measures in English or Spanish, while 
parents tend to prefer to speak in Spanish. If adolescents prefer to speak in Spanish, we will 
use a translator to administer all of the adolescent measures aloud. 
 
Rationale for Measures: Aim 1. To address Aim 1, we will assess feasibility and acceptability. 
Feasibility. PW feasibility will be assessed based upon the percent of parents willing to 
participate as well as indicators of parental engagement, including: number of  coaching 
sessions attended before teen’s discharge, number of coaching sessions attended after 
discharge, number of PW logins, number of PW online sessions completed, amount of time 
spent logged into PW program, number of logins to the parent message board, number of 
questions posted to the message board, and amount of time spent logged into the board. 
Acceptability. Acceptability will be assessed at two time points: 1) after the 4 remote 
coaching sessions  and 2) at 6, 12, and 24 week follow-up, using exit interviews and the 
Consumer Satisfaction Questionnaire (CSQ). Parent exit interviews contain questions about 
each aspect of the intervention, including the coaching sessions (e.g., number, content, 
format), text messages (e.g., content, frequency, format), and online message board (e.g., 
ease of access, content, format). Parents will also complete the 16-item CSQ, which rates 
their satisfaction with treatment delivery, their teen’s treatment progress, and their ability to 
manage their teen’s problems. Parents rate 11 items along a 7-point scale and answer 5 open-
ended questions about their experience in treatment. 
 
Rationale for Measures: Aims 2-4. Residential staff typically conduct a comprehensive 
interview with the adolescent to assess substance use, school/vocational functioning, family 
functioning, environmental risk, and other high risk behaviors. We therefore use the quick 

 
 
version of the Global Appraisal of Individual Needs (GAIN-Q3), a well-validated, 
comprehensive, structured interview with the teen to assess substance use (Aim 2) and other 
risk behaviors (Aim 3), rather than a battery of measures. The quick version of the GAIN has 
both an intake (GAIN-Q3-MI) and follow-up module (GAIN-Q3- Standard), which assess 
adolescent’s problems across several domains including: substance use, school, mental 
health, physical health, risk behaviors, work, and sources of stress. The GAIN was specifically 
developed for use with adolescents age 11 and older, and has extensive normative data with 
over 30,000 adolescents across the continuum of substance use care. The GAIN is one of the 
most widely used assessments for adolescent substance users in research and clinical 
practice. As of 2008, the GAIN had been used in over 60 adolescent research grants through 
SAMHSA’s Center for Substance Abuse Treatment (CSAT). A major advantage of using the 
GAIN is that the extensive normative data will enable us to compare the adolescents in this 
study’s sample to other adolescents in residential treatment. 
 
By using the GAIN at follow-ups, we will capture continuous data on the teen’s use and high-risk 
behaviors following discharge. We will also include measures of parental communication and 
monitoring (Aim 4), as these outcomes are not included in the GAIN and parenting practices are 
a key factor associated with ASUD. PI Becker is a certified GAIN trainer and has experience 
analyzing GAIN data. Specific scales that we will analyze to address Aims 2 and 3 are 
described below. 
Demographics. The GAIN Background section collects routine socio-demographic variables 
including age, sex, ethnicity, race, and grade in school. Items in other GAIN sections indicate 
the teen’s history of substance use or mental health treatment utilization, data that will be used 
to control for additional treatment received. 
Substance Use. The following GAIN items/scales and biological markers will address Aim 2 
(substance outcomes). 
Days of Use (Past 90 Days). A series of GAIN items evaluate days of substance use over 
the past 90 days. These items have shown excellent comparability to the well-validated Timeline 
Follow-Back Interview (TLFB). Like the TLFB, the GAIN assesses days of alcohol and drug use 
using a calendar with temporal cues (e.g., holidays, special events) to facilitate recall. We will 
analyze three variables, separately for alcohol, marijuana, and other drugs: total number of use 
days, total days abstinent, and latency to first use. 
Substance Frequency Scale (SFS). The SFS scale averages the percent of days in the past 
90 during which there was use of alcohol, marijuana, or heavy drugs; use to intoxication; and 
failure to perform activities due to use. This scale has good reliability (alpha = .85) and predicts 
substance-related problems as well or better than biometric (e.g., urine) markers of use. 
Biological markers. Biological markers will only be used at the follow-up assessments (6, 
12, and 24 weeks), since adolescents are not expected to have access to substances at the 
time of the baseline assessment (likely to be at least 1-2 days after admission). 8-panel urine 
screens that detect the presence of marijuana, cocaine, amphetamines, methamphetamines, 
MDMA, opiates, oxycodone, and benzodiazepines mailed to each family and administered to 
the teens by the parents will be used to provide a biological indicator of abstinence. Teens who 
present as acutely intoxicated based on researcher observations, parent-report, or adolescent-
report will be rescheduled. 
High-Risk Behaviors Related to Substance Use. The following GAIN items/scales will 
address Aim 3. These specific scales have been selected based on the well-documented 
association between adolescent substance use and externalizing behavior, school truancy, 
high-risk sexual behavior, and criminal behavior. 
Risky Sexual Behavior. The GAIN contains a series of items that assess sexual behavior 
over the past 90 days. Specific data obtained includes: number of partners (male and female), 
number of sexual contacts, number of times had unprotected sex, and recency of last sex. 
Days of School Attendance. Using a 90-day recall, the GAIN assesses number of days the 

 
 
teen: attended school, was absent from school due to illness, and intentionally skipped school. 
The method is comparable to that used in the Days of Use substance use items. 
Days of Legal Involvement. Using a 90-day recall, the GAIN assesses number of days the 
teen: did something, other than drug use, that would have gotten them into trouble with the 
police and number of days the teen was on probation, on parole, in juvenile detention, or in jail. 
Parenting. We use the measures below to address Aim 4, which tests the effects of PW on 
parental monitoring and communication. We use self-report measures with strong psychometric 
properties, as well as in-vivo assessment to increase the comprehensiveness of our 
assessment. If a parent loses custody after the teen’s discharge, we will not administer the 
parenting measures at the subsequent follow-up (treating parent data as missing). Based on 
prior protocols, we expect parent data loss of less than 5% with this approach. 
Parent Monitoring Questionnaire (PMQ). The PMQ is a 24 item youth and parent report 
measure designed to assess parental monitoring and sources of parental knowledge. The 
monitoring subscale has demonstrated good reliability (alpha = .82 parents, .85 youth) and 
correlates with adolescent internalizing and externalizing maladjustment, deviant peer 
relationships, and family discord. 
Parent-Adolescent Communication Scale (PACS). The PACS is a youth and parent report 
measure that assesses positive and negative aspects of general parent-teen communication 
and the content and process of parent-teen interactions. The two subscales have good reliability 
(alpha = .77 - .88) and have been shown to correlate with teen engagement in risk behavior. 
FAsTask Video Code. The FAsTask is an interactive family problem solving task that will be 
used to provide an in-vivo assessment of parenting behaviors. We have limited the assessment 
to three tasks that align with our primary aims: 1) Limit Setting (parent leads a 5 min discussion 
about a time they had to set a limit); 2) Substance Use Norms (parent leads a 5 min discussion 
on family views about substance use); and 3) Monitoring and Listening (teen leads a 5 min 
discussion on their peers and parent listens and reacts). Co-I Spirito has created a structured 
clinical codebook that defines each item to be coded and gives specific examples of high and 
low-scoring observations. Interactions will be observed during each phone or video conference 
assessment and will be audio recorded. Tapes will be coded by raters blind to condition:20% of 
tapes will be double coded.  
 
Data Analysis Plan. 
 
All 60 parents will be included in statistical analyses consistent with an intent-to-treat (ITT) 
model. Prior to the main analyses, we will run descriptive statistics on key variables to examine 
distributional properties, identify outliers, and transform variables as needed. The two treatment 
conditions will be compared on all baseline demographic and clinical variables. Pre-existing 
differences on any variables and any additional treatment received will be controlled in 
subsequent analyses.  
 
Missing data. GAIN data is entered into the GAIN’s proprietary software, which offers instant 
error checks and validation reports to prevent missing data. Other forms will be entered directly 
into study laptops using REDCap (Research Electronic Data Capture), a secure web-based 
application, to reduce missing data and entry errors. Attrition analyses will compare follow-up 
completers and non-completers on baseline clinical and demographic variables to determine if 
they differ systematically. If necessary, we will use standard methods of multiple imputation 
[123] for variables where unplanned missingness is an issue. For each follow-up time point, we 
will conduct analyses to identify systematic biases that may have arisen due to non-random 
dropout.  
 
Aim 1. In the RCT, feasibility will be examined via enrollment rates (> 80%) and indicators of 
engagement, with these preliminary targets: attendance of > 3 of 4 coaching sessions pre-

 
 
discharge and > 1 of 2 sessions post-discharge for > 75% of parents, and online usage 
patterns of 3+ PW logins, 2+ parent board logins, and 2+ hours logged in for > 75% of parents. 
Criteria for acceptability include withdrawal rates (< 20%), satisfaction ratings (> 80% of CSQ 
items rated “agree” or “strongly agree”) and positive feedback from the exit interviews with 
parents and therapists. Criteria will be finalized based on parent and staff feedback in Phase 1. 
 
Aims 2 - 4. The dependent variables (DVs) include substance use (Aim 2), related high-risk 
behaviors (Aim 3), and parental monitoring and communication (Aim 4, putative mediators). By 
nature of residential treatment, we expect teens’ level of substance use and risk behavior to 
start high at intake, drop off for the duration (~ 3.5 months) of treatment and then increase over 
the follow-up period. Trajectories that begin at baseline would be misleading, since all teens will 
have a sustained period of abstinence (with minimal variance). We therefore compare 
trajectories of use over the follow-up period, while controlling for baseline status as covariates.  
 
We will begin by comparing the DV scores (means of continuous DVs and percentages of 
categorical DVs) at each assessment. We will conduct separate mixed models predicting each 
DV by condition, controlling for the following covariates: baseline status on the DV, baseline 
differences between groups, and any mental health or substance use treatment received over 
the follow-up period. We will analyze the effect of PW dosage on each DV and calculate partial 
eta squared (η2) to estimate the proportion of variance caused by PW. We are underpowered to 
test mediation, but will examine the effects of PW on our putative mediators (Aim 4), and 
correlations between change in the mediators and change in the primary outcomes (Aims 2-3), 
with the goal of finding promising trends to pursue in a larger trial. We will cautiously attempt 
more sophisticated analyses using hierarchical modeling, a flexible approach to analyzing 
change that has been frequently used by the PI [37, 90, 91]. Mixed models are ideally suited to 
address Aims 2-4, by enabling us to compare the conditions at each time point while 
accounting for the correlation of observations over time. Although convergence is challenged in 
a small sample, it is feasible. Our primary goal will be to provide measures of association and 
95% confidence intervals to reveal the ES of PW on each DV.  
 
Sample Size, Power, and R01. We chose to recruit 60 subjects for the RCT conservatively 
estimating that 15-20% may be lost to follow-up, leaving 50 subjects with complete parent-teen 
data. This number will allow us to make judgments regarding feasibility and acceptability. As 
noted in Preliminary Studies, ES estimates in prior PW studies have ranged from small to very 
large; the only ASUD study found small to medium ES, but unlike this application, that study did 
not offer in-person support or an online parent board. We therefore may find ES in the medium 
range. Despite issues with ES stability in small samples [124], a small to medium ES paired 
with high levels of feasibility and acceptability would be an indication that the adapted PW 
intervention should be tested in a larger trial. Based on the detected ES, post-hoc power 
analyses will be conducted to determine the number of parents required for a fully powered 
RCT. For instance, for power of .8, a small ES (d = .3) would require a sample of 175 per 
group, while a medium ES (d = .5) would require a much smaller sample of 64 per group. If our 
results are promising, we will develop a fully powered R01 application in Months 31-36 (see 
Table 2) to evaluate the adapted PW under ecologically valid conditions. To speed the 
translation of research findings to practice, our R01 will use a hybrid effectiveness-
implementation design to simultaneously test the effectiveness of the intervention and inform 
the ideal implementation strategy [125].