Modification and Evaluation of the DECIDE Intervention to Improve Parent-provider Interactions in Low-income Parents of Adolescents With Disruptive Impulse Control, and Conduct Disorder
Phase: NA
Conditions: Modified DECIDE Intervention, Treatment as Usual Care Group
Sponsor: Indiana University

DECIDE Parent-Provider Interaction 
IRB Protocol 
 
 
 
Modification and evaluation of the DECIDE intervention to improve 
parent-provider interactions in low-income parents of adolescents with 
Disruptive Impulse Control, and Conduct Disorders 
 
NCT number: NCT04445155 
 
Date: 12/06/2022 

DECIDE Parent-Provider Interaction 
IRB Protocol 
 
 
 
 
 
 
 
 
 
 
Modification and evaluation of the DECIDE intervention to improve parent-provider 
interactions in low-income parents of adolescents with Disruptive Impulse Control, and 
Conduct Disorders (DECIDE) 
IRB #1911897011 
 
 
Susan Perkins, PhD 
Indiana University School of Medicine and 
Richard M. Fairbanks School of Public Health 
410 West 10th Street, Suite 3000 
Indianapolis, IN 46202 
(317) 274-2626 

DECIDE Parent-Provider Interaction 
IRB Protocol 
 
 
 
 
 
 
 
 
Table of Contents: 
1.0 
Rationale 
2.0 
Background 
3.0 
Specific Aims 
4.0 
Inclusion/Exclusion Criteria 
5.0 
Enrollment/Randomization 
6.0 
Study Procedures 
7.0 
Reporting of Adverse Events 
8.0 
Study Withdrawal/Discontinuation 
9.0 
Statistical Considerations 
10.0 
Privacy/Confidentiality 
11.0 
Record Retention 

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1.0 
Rationale 
 
Interventions to optimize parent-provider interactions are urgently needed to ensure adolescents with 
Disruptive, Impulse-Control, and Conduct disorders (DIC) receive the behavioral health care they need. DIC affect 5 
million (1 in 5) American adolescents aged 12 to 17 years.1 DIC are characterized by emotional and behavioral 
dysregulation manifested by behaviors that are aggressive, infringe on the rights of others, violate social norms, 
and result in conflicts with authority figures.2 For these adolescents, behavioral health care is complex, long-term, 
and requires parental participation.3-5 Research by our team and others showed parents of these adolescents 
report that providers do not listen to them or involve them in their adolescents’ care.6-8 Research shows providers 
have biases and limited skills and confidence to communicate with these parents to encourage them to voice their 
concerns and care preferences.9-12 Low income and/or minority parents are at greatest risk for not being involved 
in their adolescents’ behavioral health care, having poor interactions with providers, being more likely to perceive 
poor quality of their adolescents’ behavioral health care, and having low treatment engagement.13-18 If 
unaddressed, poor parent-provider interactions interfere with adolescents’ retention in behavioral health care.19,20 
No evidence-based interventions have targeted both parents and providers to optimize their interactions and 
improve behavioral health care for adolescents with DIC.3,21 
To address these problems, we propose modifying the evidence-based DECIDE intervention to target low 
income and/or minority parents and providers of adolescents with DIC. DECIDE stands for Decide the problem; 
Explore the questions; Closed or open-ended questions; Identify the who, why, or how of the problem; Direct 
questions to your health care professional; Enjoy a shared solution. DECIDE was developed for ethnically/racially 
diverse adult patients with serious mental illness,22 and the latest evidence-based iterations include intervention 
components targeted to and shown to increase patient activation, provider communication, and patient-provider 
interactions.22 DECIDE has two primary components: 1) three patient training sessions designed to help patients 
effectively ask questions and participate in decisions about care: and 2) a 12-hour workshop and up to 4 individual 
coaching sessions for providers to improve perspective-taking, reduce attributional errors, and increase receptivity 
to patient participation. DECIDE has improved patient activation,23,24 self-management,23 perceived quality of 
care,23and collaborative treatment decision making.22 
2.0 
Background 
 
Adolescents with disruptive, impulse-control, and conduct disorders (DIC), especially those in low 
income and/or minority families, present some of the nation’s most pressing behavioral health care challenges. 
Five million (1 in 5) adolescents 12-17 years of age are diagnosed with a DIC that includes the following DSM-5 
diagnoses: (a) Oppositional Defiant Disorder, (b) Conduct Disorder, (c) Intermittent Explosive Disorder, (d) 
Pyromania, (e) Kleptomania, (f) Other Specified DIC Disorder, and (g) Unspecified DIC.1,2,26 DIC are characterized by 
emotional and behavioral dysregulation manifested in externalizing behaviors that are aggressive, infringe on the 
rights of others, violate social norms, and result in conflicts with authority figures.2 Annual medical costs average 
$14,000 per child with Conduct Disorder compared to < $2300 per child without a mental disorder.27 Annual direct 
medical costs range from $17 to 56 billion for those with DIC.27-29 Parents incur financial costs associated with 
interruptions in employment due to caregiving responsibilities, increased healthcare needs for their own stress- 
related illnesses, and their child’s treatment.30-33 Approximately 57% of children with mental health disorders, 
including DIC, come from households living at or below the federal poverty level,34 and low income and/or 
minority parents are particularly vulnerable to the negative effects of caregiving for adolescents with these 

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disorders.18,35-37 Problems associated with DIC are exacerbated during adolescence due to rapid developmental 
changes and increased substance abuse and criminal activities.38 
The effective treatment of adolescents with DIC depends on their parents’ active engagement with 
behavioral health care providers.39,40 In addition to managing their adolescents’ problem behaviors and their own 
distress over such behaviors,31,32,36,41,42 parents of adolescents with DIC must attend frequent and often urgent 
meetings with providers.6,7,43-45 Active parent involvement with the mental health system is required due to the 
complex treatment regimens needed by adolescents with these disorders and the high-risk nature of their 
behaviors.32,44,46-48 Parents report that encounters with providers are often time-consuming, stressful, stigmatizing, 
exhausting, and unhelpful.7,30 Negative interactions with providers contribute to parent disengagement from their 
adolescents’ care and resistance to following provider recommendations, both of which lead to poor adolescent 
outcomes.49,50 
 
Low income and/or minority parents of adolescents with DIC are at high risk for aversive interactions 
with providers due to socioeconomic disadvantages.32,51,52 Research has shown that effective communication 
skills deployed by consumers in healthcare encounters, such as asking informed questions and clearly articulating 
opinions and needs, are associated with greater satisfaction with care and better health outcomes.53-57 However, 
low income and/or minority persons often have less opportunity to acquire these skills due to low educational 
attainment, poor health literacy, disadvantaged social position, and limited resources.47,58-60 Negative interactions 
are fostered by providers who perceive low income and/or minority health consumers to be uninvolved, 
uniformed, and unable to make complex health care decisions,8,19,47,61,62 and lack of training about how to motivate 
low income and/or minority persons to voice treatment concerns and preferences. 18,59,60,63-65 
Scientific Premise: To address the above issues, research suggests appropriate target variables for 
parents and providers are parent activation, provider communication, and parent-provider interactions. 
Activation is a person’s acquisition of knowledge, skills, and beliefs that facilitate active participation in health 
care.66,67 High activation in adult patients with chronic illness,68-77 such as diabetes,78 HIV/AIDS,79 hypertension;80 
and serious mental illness81-85 such as schizophrenia57 is associated with better health status and adherence to 
healthy behaviors.57,67 Consumers who are well informed about health conditions and who are confident in their 
abilities to navigate the healthcare system and manage their care have better health outcomes.47,57,86 In addition, 
improving provider communication increases satisfaction, adherence, and health outcomes in pediatric and adult 
populations with physical and mental health concerns.86,87 Multiple factors contribute to the quality of patient- 
provider interaction including provider communication and institutional practices.37,47,86,88,89 Effective provider 
communication is characterized by attentive, facilitative, and collaborative behaviors.22,86 
 
Benefits of parent interventions will not be fully realized without collaborative parent-provider 
interactions.90 Several parent support and skills training interventions have been shown to improve: 1) parent 
knowledge and management of their children and adolescents’ behavior problems;91-98 2) parent mental health 
and stress levels;93,94,99 and 3) parent self-efficacy in accessing and navigating adolescents’ mental health 
services.100,101 Moreover, activation interventions in adult behavioral health have demonstrated that patient 
activation in the absence of provider support can lead to harmful effects, including further exacerbation of tension 
in patient- provider relationships or diminished patient use of services particularly in low income and/or minority 
patients.23 Patients’ perception or belief that the provider is supportive (receptive) of the former’s efforts to be 
actively involved in treatment may act as a mediator of intervention effects.22,23 Alegria and colleagues suggested 
that patients’ beliefs that providers will support their activation efforts may significantly contribute to benefits of 
patient-provider interactions, patient perception of management of care, perceived quality of care, and 
engagement and retention in care.23 
Our proposed focus on both parents and providers is innovative in this field. In DIC and other mental 
health disorders, there are several support programs or interventions targeting parents. However, there are no 
(zero) interventions targeting providers, and no interventions targeting both parents and providers. This was 
confirmed in a PubMed search of all existing English-language literature using terms “parent, mental health, 
activation or empowerment, and intervention”. 

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Our target variables are innovative in this field. Improving parent activation improves interactions with 
providers 17,21,102 yet only two studies to date have tested parent activation interventions in adolescent behavioral 
health care.102,103 These two studies102,103 showed positive effects on parent activation and perceived efficacy to 
work with mental health providers.104 However, neither study intervened with providers. Similarly, improving 
provider communication increases satisfaction, adherence, and health outcomes,86,87 Yet there are no such existing 
interventions for parents of children with DIC. This was confirmed in a PubMed search of all existing English- 
language literature using terms “parent - provider communication, mental health, and intervention. Provider 
communication interventions have been developed to improve encounters between healthcare providers and 
adult patients with physical health concerns,58,105,106 and parents of children in pediatric primary care.51,54,107,108 
However, evidence-based parent-provider communication interventions for parents of children with mental health 
disorders, including DIC, have not been developed. Thus, this is the first intervention to improve interactions 
between parents and providers of adolescents with DIC. 
 
Our inclusion of low income and/or minority parents addresses an understudied population. The 
existing parent activation intervention studies focused on military families102,109 or Latino parents.104 The military 
sample was majority white (73%) and middle income. Our study will include a more racial/ethnic diverse sample. 
 
3.0 
Specific Aims 
 
The purposes of this two-phase study are to modify and test the DECIDE intervention (referred to as 
DECIDE from now on) for parents and providers of adolescents with DIC. In phase I, our team in Indianapolis, IN 
(Drs. Oruche, Draucker, Perkins, parent and provider advisory boards) will work with two consultants to modify 
DECIDE. Dr. Nakash will help modify the DECIDE provider components to be relevant for DIC. Dr. Chacko will help 
modify DECIDE from patient to parent focused. In phase II, we will test modified DECIDE against usual care in 
parents and providers of adolescents with DIC using a two-group, pilot, randomized, controlled design. During 
phase II, Dr. Oruche became a Co-Investigator at the University of South Florida in Tampa, FL. Dr. Chacko (New 
York, NY) has clinical expertise in improving activation among parents of adolescents with DIC. Dr. Nakash 
(Northampton, MA) led the design and implementation of DECIDE components targeted to providers25 Dr. Chacko 
will help modify DECIDE from patient to parent focused. Our setting is a large, safety net health system in the 
Indianapolis metropolitan area servicing primarily low income and/or minority persons. 
Specific aims are to: 
 
Phase I, Aim 1. Modify DECIDE for low income and/or minority parents and providers of adolescents with DIC. 
 
Phase II, Aim 2. Evaluate the feasibility and acceptability of modified DECIDE. 
 
Phase II, Aim 3. Estimate preliminary effects of modified DECIDE to improve parent, provider, and adolescent 
outcomes. We hypothesize that compared to usual care: 
 
Hypothesis 3.1. Modified DECIDE parents will show greater improvements in: 1) activation; 2) parent- 
provider interactions; 3) perceived management of adolescents’ behavioral health care, 4) perceived 
quality of adolescents’ behavioral health care, and 5) engagement in adolescents’ behavioral health care. 
Hypothesis 3.2. Modified DECIDE providers will show greater improvements in: 1) communication skills 
and 2) parent-provider interactions. 
Hypothesis 3.3. Adolescents of modified DECIDE parents and providers will show higher rates of retention 
in behavioral health care. 
 
If study findings are positive, we will be poised to test the modified DECIDE in a fully-powered R01 level 
randomized, controlled, multi-site clinical trial. If study findings are negative, we will have process and outcome 
information needed to further refine DECIDE or pursue different interventions. Either way, this line of research has 
potential to optimize parent-provider interactions and ultimately, ensure adolescents with DIC receive the 
behavioral health care they need. 

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4.0 
Inclusion/Exclusion Criteria 
Inclusion Criteria: 
Inclusion Criteria for providers and interns: Providers will be regular paid staff members who are: 
(1) Associate’s or bachelor’s or PhD prepared providers who work with parents OR 
 
(2) Masters-prepared clinical social workers or mental health counselors and 
(3) Provide behavioral health services to adolescents and their parents. OR 
(4) Doctoral level interns (e.g. in psychology) and 
(5) Provide behavioral health services to adolescents and their parents OR 
(6) Providers who are bachelor’s prepared interns must: 
(1) be currently working with a center or private practice to complete requirements for their Master's 
degree and 
(2) be providing behavioral health services to adolescents and their parents. 
 
Inclusion Criteria for Guardians: Guardians will have a child or adolescent with DIC receiving services from a 
participating mental health provider. Parents/guardians meeting all the following criteria are eligible: 
(a) are aged 21 or older 
(b) speak English 
(c) are the guardian (biological parent, adoptive parent, step parent, foster parent, or legal guardian) of the child or 
adolescent or a parent surrogate serving in a primary caregiver role (referred to as “parents”; if foster parent or 
legal guardian, ). 
(d) must have a child or adolescent aged 3 to 17 years with a diagnosis of Disruptive Impulse Control and Conduct 
Disorder (DIC) by a mental health professional. (This includes children with behavior problems, such as 
Oppositional Defiant disorder, Conduct disorders, or Intermittent Explosive disorders). 
(e) Attends regular appointments with a provider 
(f) Foster parents will be included if they have a child with DIC now or in the past, and regardless of whether that 
child is receiving services from a participating mental health provider or not. 
 
Exclusion Criteria for parents: 
- 
Show significant cognitive impairment or acute emotional distress on screening 
- 
Have an incarcerated adolescent 
No providers or parents will be excluded on basis of race/ethnicity, gender, or sexual orientation. 
 
5.0 
Enrollment/Randomization 
Screening 
Providers currently employed at Sandra Eskenazi Mental Health Hospital, Bowen Center, Centerstone, and 
other applicable mental health centers or private practice will be approached for inclusion on the study. Providers 
with at least one patient who is aged between 6-17 and diagnosed with DIC disorders will be screened for 
enrollment. 
 
Informed Consent 
 
A study investigator or research assistant will obtain informed consent from the provider either via a 
HIPPA compliant teleconferencing platform (ie Zoom Health) or via telephone contact. Parents who become 

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enrolled will be approached via telephone contact. Informed consent for parents will be obtained virtually via a 
HIPPA compliant teleconferencing platform (i.e., Zoom Health) or telephone contact. 
Randomization 
 
All participants will be assigned to the intervention arm and there will be no randomization. Instead, the 
intervention results will be compared to historical data. 
 
Study Duration/Timeline 
 
The study will consist of the provider completing baseline measures and then complete a 4.5 hours (max) 
workshop through Canvas Learning System, completed over the course of 2-3 weeks. After the provider completes 
the workshop, he/she will be contacted by study staff to complete the post-intervention measures (T2) and 
conduct a recorded qualitative interview. The parents will complete baseline (T1) study measures before meeting 
with the parent trainer. Then all will participate in up to three, hour-long sessions training sessions with a parent 
trainer. In total, participation in the study will last between 6-8 weeks. 
 
6.0 
Study Procedures 
 
1. Theoretical Framework. DECIDE is grounded in mental health disparities frameworks113, 24 and social 
cognitive principles.114 The parent component is designed to increase parent activation, to help effectively ask 
questions and participate in decisions about care.23,112 66,111 The provider component is designed to teach provider 
communication skills in listening, eliciting the patient’s agenda, encouraging question, and providing management 
education. 
2. Preliminary Studies. Drs. Oruche, Draucker, Perkins, and Chacko collaborated on the preliminary 
studies below. For this application, we added Dr. Nakash (Consultant) who is a nationally recognized researcher 
and clinician with expertise in racial/ethnic disparities related to provider level factors. Our preliminary work is 
below. 
 
Preliminary study 1. Through this qualitative descriptive study (internal funding), Drs. Oruche and 
Draucker identified the most salient needs and challenges of parents of adolescents with DIC. Results indicated 
that parents’ interactions with providers were often aversive, stressful, and nonproductive; suggesting need for an 
intervention.7,115 
 
Preliminary study 2. Similar to the proposed study, we used a 2-phase study to develop and preliminarily 
test an intervention called FAME (Family Management Efficacy) for parents of adolescents with DIC. With funding 
(KL2TR001106, UL1TR001108), Oruche, Draucker, Chacko and a parent and provider advisory board, developed 
and tested this 6-week parent group-based, in-person intervention among low income African American parents of 
adolescents with DIC aimed at enhancing parent activation and improving interactions with behavioral health care 
providers.116 The setting was the same as for the proposed study. FAME was acceptable but not feasible, and did 
not show preliminary efficacy on key outcomes because it did not have a provider component. Facilitators noted 
some parents struggled to develop effective communication skills (e.g., asking questions of providers, sharing ideas 
about the adolescents’ treatments). The team gained valuable experience in intervention delivery to parents of 
adolescents with DIC and confirmed the importance of simultaneously targeting providers. These lessons inform 
modification of the evidence-based DECIDE intervention in this proposed study.117 
Preliminary work for this application. Drs. Oruche, Draucker, and Perkins collaborated with Drs. Nakash 
(40 hours past 3 months) and Chacko (10 hours past 3 months), on the following components of this application: 
identification of target variables for the modified DECIDE, creation of the study conceptual model, selection of 
study measures, and overall study design. 
 
3. Methods 

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DECIDE Intervention. The evidence-based DECIDE intervention was developed for low income and/or 
minority adults with serious mental illness and their providers.22 DECIDE has both patient and provider 
components. DECIDE has improved patient activation,23,24 patient self-management,23 perceived quality of 
care,23and improved collaborative treatment decision making.22 Because DECIDE was designed for individuals who 
work with adult patients, we will adapt it for parents and providers of adolescents with DIC. For example, case 
examples need to be relevant to the clinical work with this population and accommodate individual or family 
therapy; we will also shorten the provider training – to increase feasibility of implementation and acceptability to 
participants. This fits with Stage 1A and 1B of the ORBIT model.118 
 
The modified DECIDE will have parent and provider components. 
The parent component is designed to teach parents how to effectively ask questions and participate in 
decisions about their adolescents’ behavioral health care. It will include up to three 60 minutes sessions (the third 
session is optional). Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical 
interactions and encourage participation and decision making in care. Session 2 (Self-efficacy and Consolidation) 
encourages parents to ask questions about their adolescents’ behavioral health and health care and treatment 
options . Session 3Optional Booster), which can discuss any previous topics the parent would like the trainer to 
review and can also include more practicing of asking questions). 
The provider component is designed to improve provider communication in three key areas: 1) 
perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative 
parent behaviors to character traits instead of considering the situational factors; and 3) receptivity to parent 
participation and collaboration. We will shorten the provider training to increase feasibility of implementation and 
acceptability to participants. The training will included one 4.5-hour (rather than 12-hour) group workshop. 
 
 
 
Intervention Delivery. In addition to standard care, all participants will receive the modified DECIDE. 
Parents receiving intervention will receive up to three 60-minute sessions over the course of three weeks. The 
sessions will focus on increasing the parent’s involvement in decision-making, increasing their understanding of 
the decision-making process, and training the parents to ask questions concerning their adolescent’s care. These 
training sessions will be delivered by trained study staff virtually via HIPPA compliant video teleconferencing 
platform (ie Zoom Health) or via Telephone as approved by IRB. 
Phase I, Aim 1 
Recruitment of Parent Advisory Board. We will form a 5-member parent advisory board to guide 
modification of DECIDE. Inclusion Criteria. Parents of adolescents with DIC, who are receiving services at Midtown 
Child and Adolescent Program. We will invite parents sequentially in the clinic as well as parents from our previous 
study advisory board and who participated in preliminary study 2 that agreed to be contacted for future studies. 
Recruitment of Provider Advisory Board. We will form a 5-member provider advisory board to guide 
modification of DECIDE. Inclusion Criteria. Midtown Child and Adolescent Program staffs who do not meet the 
inclusion criteria in phase II (i.e. manager and clinical coordinators or supervisors). We will invite two other direct 
care providers who work in the healthcare system but not at recruitment site. No parent or provider will be 
excluded on basis of race/ethnicity, gender, or sexual orientation. 
 
DECIDE Modification. Dr. Oruche has met both Dr. Nakash and Midtown Chief Executive Officer, Program 
manager and clinical coordinators to discuss potential modifications to the provider intervention to increase 
acceptability and feasibility. We will invite their continued participation during phase I. The research team and 
provider advisory board will meet monthly for ~ 3 months to modify the intervention. At the initial meeting, the PI 
will share DECIDE and discuss what components need to be modified. The research team will prepare the modified 

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intervention materials and present modifications to the provider advisory group for iterative feedback. The same 
process will be followed to modify the parent component of the DECIDE intervention. Together, research team and 
the parents’ advisory group will meet twice during the first 4-months of study period. We will (a) share the parent 
component of the DECIDE intervention, (b) discuss what components need to be modified, (c) have the team do 
the modifications; and (d) present them back to the parent advisory group for iterative feedback. 
 
Phase II, Aims 2 and 3. 
 
Design. A pilot trial to assess feasibility and estimate outcomes in intervention vs. an historical control. 
 
Setting. Similar to preliminary studies, we will conduct this trial at Sandra Eskenazi Mental Health Hospital 
in Indianapolis, IN, Bowen Center in Indianapolis, IN, Centerstone centers in Indiana, Florida and Tennessee, other 
applicable mental health centers and private practice in the US. Midtown is the largest publicly funded mental 
health center in Indiana and serves primarily low income and/or minority population (see Facilities and Resources). 
Child and Adolescent Program employs 22 masters-prepared mental health providers. Oruche also has clinical 
privileges at Midtown to facilitate recruitment (see support letter). Midtown has named treatment engagement as 
a top strategic priority. 
Sample. First, we will recruit 16 providers and then work with them to invite parents (or parent 
surrogates) of adolescents aged 6 to 17 years who have been diagnosed with a DIC disorder. Ideally, we will enroll 
80 parents (5 parents per enrolled provider). 
 
Sample size justification. Because this is a feasibility pilot study, statistical models will be fit to estimate 
effect sizes for use in a future randomized trial. Any inferential testing is considered exploratory though effect sizes 
of ≥0.65 could be detected with 80% power in the models described below assuming pre/post exposure 
correlation of 0.5, intraclass correlation of 5%, and two-tailed test (α=0.05). We will follow the recommendation of 
Hertzog119 that a minimum of 30 participants per group are needed for pilot studies to examine group 
comparisons.119 To account for potential 20% dropout, we will recruit 40 parents to the intervention group with 1- 
5 parents per provider) for up to a total of 80 parents. Provider sample size is based on availability. 
 
Procedures. Enrollment, consent, and baseline data collection. Providers. PI will attend provider team 
meeting at Midtown to introduce the study, answer questions, and invite them to participate. Trained research 
assistants (RA) will obtain verbal informed consent from interested providers. Parents. To screen parents, we will 
enlist the help of providers and administrative assistants at the clinic, who have access to providers’ caseloads, 
schedules, and adolescent patient demographics. To coordinate recruitment, we will ask the administrative 
assistants to select adolescents between 6 to 17 years who are diagnosed with DIC. PI and RAs will work determine 
provider schedules or enrolled parents’ next visit. Parent eligibility and consent to participate will be determined 
by calling parents via telephone or a HIPPA compliant teleconferencing platform (ie Zoom Health). If RA does not 
make contact with parent, RA will send study flyer and recruitment letter co-signed by PI and Child and Adolescent 
Program Manager. RA will make follow-up contact within 7 days after the sending the study materials.. If parent 
express interest in participation, the RA will determine eligibility. Next, RA will obtain verbal consent from 
interested parents.. Following enrollment, RA will collect baseline data from all providers and parents.. Training for 
providers will occur as soon after baseline measures are collected. 
 
Revised Study Schema: 
Figure 2: Study Schema 
Providers 
Recruitment 
Screening 
Consent 
Baseline 
Modified DECIDE intervention 
[workshop (1 @ 4.5 hrs)] 
Time 2 
DECIDE Oral Interview (all 
providers) 

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Parents 
Recruitment 
Screening 
Consent 
Baseline 
Modified DECIDE sessions 
2 @ 1 hr/week, with an 
optional 
3rd booster session offered @ 
1 hr/week 
Time 2 
DECIDE Oral Interview (subset of 
parents) 
Green: Quantitative measures and oral interviews 
All participants will receive the DECIDE intervention. Results will be compared to historical control. 
Training for parents will be delivered remotely using telephone and/or Zoom Health for parents with video 
capability. The parents will be sent a Zoom Health invitation which include a toll free number they can call. This 
allows research staff to record sessions for fidelity checks. 
 
 
Data collection. A trained study staff will collect baseline data (T1) before the provider takes the DECIDE 
Training and will schedule a follow-up assessment 1- 4 weeks post intervention training (T2). Providers will be 
instructed to think specifically about the most recent therapy session that he/she had with a parent of a child 
diagnosed with DIC in order to keep the parent provider interaction fresh in the provider’s mind when completing 
the measures. Study staff will follow these same guidelines for scheduling the T2 data collection. Providers will 
complete and enter their surveys directly into REDCap. Providers will be contacted by study staff to remind them 
to complete their surveys and to answer any questions if necessary. Study staff will schedule an appointment with 
providers to collect the post-intervention (T2) measures in order to ensure the provider understands the 
instructions and also to conduct the post-intervention qualitative interview. Providers will be instructed to think 
specifically about the most recent therapy session that he/she had with a parent of a child diagnosed with DIC in 
order to keep the parent provider interaction fresh in the provider’s mind when completing the measures. Parents 
will be contacted and asked to schedule a convenient time to complete the surveys with the study staff. 
 
Measures. 
 
Aim 2 measures. The research project coordinator will keep logs and field notes of feasibility including: 1) 
enrollment rates, reasons for ineligibility and declining participation; 2) attrition rate, reasons for missed session or 
intervention completion; and (3) measurement completion rates. We will measure parent and provider 
acceptability and satisfaction with modified DECIDE using Client Satisfaction Questionnaire (CSQ) and in-depth 
semi structured interviews at T2. RAs under Draucker’s supervision will conduct in-depth semi-structured 
interviews including: All intervention providers (n = 8) and two of each of the parents (n = 16). To explore different 
levels of acceptability by parents, for each provider, one parent will be chosen who has a high score (> 3) on the 
CSQ and one parent who has a low score (< 3). Both parents and providers will be asked about their experience 
with the intervention, what was helpful or not, and how they would change the intervention. 
 
Aim 3 measures. Parents, providers, and adolescents’ socio-demographic factors will be assessed at T1; 
and outcomes will be assessed at T1 and T2. We will include three items (i.e., level of parent organization, 
involvement, and management of adolescents’ care) from the Child and Adolescent Needs and Strengths (CANS) at 
Midtown’s request. We will use self-administered questionnaires with read-aloud procedures to address issues of 
literacy. All measures have well-established psychometric properties, sensitivity to change, and acceptable 
response burden.120-127 Multi-informant and mixed methods assessment of outcomes is a study strength. Given 
the change in design to one group pre and post intervention compared to historical group; we will use the Parent 
Participation Engagement Measure (PPEM). In lieu of Working Alliance Inventory or Kim Alliance Scale as our key 
measure of parent-provider interaction or engagement. 

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Compensation. All parent participants will receive a $25 gift card for each assessment completed and $25 
gift card if an oral interview is completed. They will receive a $10 gift card for each training session attended. We 
will offer continuing education credits (CE) for the 4.5-hr provider workshop. Dr. Oruche has arranged with her 
school’s Center for Continuing Education and Lifelong Learning to offer the CE credits at minimal cost. Providers 
will also receive $100 upon completion of the T1 measures, the DECIDE Workshop, T2 measures and the 
qualitative interview if located at any center that is not Bowen or Eskenazi. 
 
Intervention Fidelity. We will follow the treatment fidelity protocols developed for the original DECIDE 
trial and the NIH Treatment Fidelity Workgroup recommendations to ensure intervention integrity and minimize 
drift/group contamination.128 Design. We are comparing an historical control data to intervention data gathered 
during the study.. Provider training. All study personnel will receive training specific to their role; regular 
supervision and retraining as needed. We will fully manualize the modified intervention similar to the original 
DECIDE intervention with standardized treatment protocols, training manuals, and training content,25,129,130 
modified from patients to parents of adolescents with DIC. Treatment Delivery. Parent and provider intervention 
delivery will be assessed using a random sample of recorded trainings and checklist of key intervention 
components. Receipt and Enactment of Treatment. Facilitators for parent component will complete a session- 
specific field note entry that summarizes parent responses (i.e., level of engagement and understanding) and any 
potential external factors (e.g., interruptions, noise) that may have influenced their response. 
7.0 
Reporting of Adverse Events 
Participants will be monitored for adverse events on a daily basis. Any adverse events will be reported to 
PI immediately and IRB immediately. The research investigative team will be responsible for data and safety of this 
study and include Ukamaka Oruche, PhD, RN (Co-I)); Claire Draucker, PhD, RN (Co-I), Susan Perkins, PhD (PI), Ora 

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Nakash (Consultant), and Anil Chacko (Consultant). In addition to monthly research team meetings, the committee 
will meet as soon as possible following the occurrence of any adverse events. 
Data. Parents and providers (participants) in this study will be assigned a participant identification 
number (PIN). Research materials such as parent and provider interviews will contain the PIN instead of the 
participants’ names. A file containing a link between the PIN and the participants’ names will be created and 
access to this file will be restricted to key research staff such as the Project coordinator and only for the purpose of 
scheduling interviews. All research staff will be required to complete training in Human Subjects protection 
sponsored by the Indiana University Office of Research Compliance. This includes basic human subjects’ protection 
and advanced training on Health Insurance Portability and Accountability Act (HIPA) and Conflict of Interest. The 
staff will also receive additional training on working with participants or handling identifying information. 
 
After obtaining consent from the parent, the research team will access their administrative data, and 
parent interviews for purposes of this study. Once at research team offices at the university offices, all documents 
that include identifying information (i.e. names, addresses and telephone numbers) will immediately be separated 
from the parent assessments, and recordings. These items will be stored by research staff authorized by the PI in a 
locked file and an identifying case number will be generated. The PI and authorized research staff will be the only 
persons with access to the locked filing cabinet and/or any information or files that link the case number with any 
parent identifying information. No reports will be made public using any names or identifying information. Raw 
data and accompanying research protocols will be kept for at least 7 years post publication of findings, as required 
by Indiana University. Strict measures to assure confidentiality of the data will be taken. Computerized data will be 
identified by participant number only. All research staff PCs are password-protected and have standardized, full 
featured, software and hardware configurations. Only research staff authorized by the PI will have access to the 
data. 
 
Data analysis will be conducted with use of coded data to reduce the chance of inadvertent disclosure. Dr. 
Perkins and her statistical team working with the data are the only persons on-site with network level 
administrative password privileges. The original data and the encrypted data will not be transported or used at any 
other location and the data will not be copied onto other computers, discs, CDs etc. We will maintain all print-outs, 
electronic files, personal computers with restricted data on the hard drives, or other physical products containing 
data in locked cabinets, file drawers or other secure locations when not in use. Printed material that includes 
analyses based on restricted data will be promptly destroyed. At the end of the project, all files that include 
restricted data will be destroyed, including copies and subsets on the Indiana University server or any project 
computers. 
 
Safety. The committee will monitor adverse events reported by participants and reasons for dropping out. 
Adverse events will be reported to the study PI or her designee within 24 hours, and any serious unexpected 
adverse events related to the study intervention will be reported to the Institutional Review Board within 5 
working days. The relationship between adverse events and the study intervention will be determined based on PI 
and her research staff examination of the subject (research staff and/or patient) and subsequent clinical judgment. 
Both provider and parent participants will have several phone numbers to call should they have any concerns or 
questions about any aspect of the study, including contact numbers for the PI, the project coordinator, the IRB 
offices, and the parent/patient representatives at Midtown. All other adverse events will be reported annually 
with the continuing review. Study Withdrawal/Discontinuation. Taking part in the study is voluntary. A participant 
may choose not to take part in the study or to withdraw from the study at any time. If the participant withdraws 
from the study, he/she will not be penalized in any way and will not lose any benefits he/she is entitled. The 
participant may choose to contact the study PI to formally withdraw, or he/she may simply choose to stop coming 
to the study sessions. If the participant chooses to withdraw, a study representative will call the participant to 
make sure he/she is ok. The study representative will provide the participant with contact numbers to obtain other 
resources. For example, parents may be provided number to other Midtown programs or National Alliance on 
Mental Illness (NAMI) Indianapolis. In addition, the PI will meet monthly with the research project coordinator to 
review data collected to date in order to determine if there are any major problems in data collection procedures 
or data collected. 

DECIDE Parent-Provider Interaction 
IRB Protocol 
 
 
 
 
8.0 
Study Withdrawal/Discontinuation 
 
After signing the informed consent, participants can withdraw and leave the study at any time. Members 
of the study team will assist participants in withdrawing if that is the wish of the participant. Withdrawing from 
the study will not impact the participant’s healthcare in any way. 
 
9.0 
Statistical Considerations 
 
We will calculate the proportion eligible that enroll and proportion completing the intervention for both 
parents and providers. We will tabulate responses to Parent and Provider Satisfaction with Intervention items and 
calculate the proportion of parents and providers who have a mean ratings of at least 4 on the 5-point scale 
(satisfied or highly satisfied). Effect sizes will be estimated by fitting linear mixed models, with parent, provider, or 
observer target and outcomes variables, all measured at T2, as outcomes and treatment group (intervention or 
usual care) as the explanatory variable. All models will also include the T1 outcome as a covariate and random 
effects for provider and parent nested within provider to account for clustering. Effects sizes will be estimated with 
ω2. Analyses will be intent-to-treat and conducted using SAS Version 9.4 (SAS Institute Inc., Cary, N.C., Copyright 
2002-2012). 
Supplementary Analyses: We will investigate how the adjustment for covariates (age of child, sex of 
provider and parent, parent race and income, severity of child illness and duration in treatment) impacts effect size 
estimates by adding interaction terms to models and estimating effect sizes separately for different levels of the 
covariate (e.g. male and female for parent gender). Missing Data: We will compare baseline variables between 
subjects who drop out of the study to those who do not using two-sample t tests, chi-square tests or their non- 
parametric equivalents as appropriate. If we find that the missing data appear to be MNAR, this information will be 
used in designing the larger trial. Because of the relatively small sample size, we will not attempt to model the 
missing data mechanism in this pilot study. Sex as a biological variable: As noted above, we will estimate effect 
sizes by sex for all outcomes. Draucker will lead the qualitative analysis of the semi-structured interviews with 
input from PI and research team. The interviews will be coded with standard content analytic procedures.13 
 
10.0 
Privacy/Confidentiality 
A secure web-based system (REDCap) will be used to capture study data. Participation in this research is 
covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers may not disclose 
or use any information, document, or specimens that could identify any participants in any civil, criminal, 
administrative, legislative, or other legal proceeding, unless participant consents to it. 
 
11.0 
Record Retention 
Records will be retained for up to seven years post study completion. 

DECIDE Parent-Provider Interaction 
IRB Protocol 
 
 
 
 
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