Optimizing Residential Treatment Gains for Adolescents

Study Overview
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Brief Summary
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The goal of this randomized controlled trial is to determine the feasibility, acceptability, and preliminary effects of a web-based parent training (Parenting Wisely) augmented with facilitated parent groups (referred to as PWRT). PWRT is designed to prepare parents for the reintegration of their adolescents in the home after intensive psychiatric residential treatment. Researchers will compare PWRT to treatment as usual to determine whether PWRT effects target mechanisms (i.e., family function, social support, parental self-efficacy, parenting practices) and adolescent outcomes (i.e., internalizing and externalizing behaviors, placement restrictiveness).

Detailed Description
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A randomized controlled trial (RCT) design is employed to evaluate the feasibility, acceptability, engagement of target mechanisms, and preliminary effects of PWRT in parents with adolescents transitioning from residential treatment (RT) to the community. Parents (n=60) will be randomly assigned to receive Parenting Wisely augmented with facilitated discussion groups (referred to as PWRT; n=30) or treatment-as-usual (TAU; n=30). In the PWRT condition, parents will complete 2 web-based modules in an online parent training program called Parenting Wisely. Parents will also attend a 90-minute discussion group via Zoom. The RCT will allow for testing of target mechanism engagement (i.e., parental self-efficacy, parenting behaviors, social support, family function) and the intervention's effects on adolescent outcomes (i.e., internalizing behaviors, externalizing behaviors, placement restrictiveness). Parents will complete assessments at baseline (T1), six weeks post-baseline (T2), and six months post-baseline (T3) via REDCap. While adolescents (n=60) will not directly receive the intervention, they will complete assessments at baseline, six weeks post-baseline (T2), and six months post-baseline (T3). Aim 1: Evaluate the feasibility and acceptability of PWRT. 1a. Evaluate the feasibility of PWRT by tracking the frequency (discussion group attendance, PW logins), dose (module and practice exercise completion), and duration (time spent in PW and discussion groups). 1b. Evaluate the acceptability of PWRT for parents with adolescents in RT via a satisfaction survey. Aim 2: Determine the effects of PWRT on the target mechanisms compared to the TAU condition from baseline to 6-weeks and 6-months post-baseline. Aim 3: Determine the effects of PWRT on adolescent outcomes compared to the TAU condition from baseline to 6-weeks and 6-months post-baseline. 3a. Determine if changes in the target mechanisms are associated with adolescent outcomes at six weeks and six months post-baseline. Exploratory Aim: Explore the feasibility of collecting data from adolescents in an RT facility by tracking frequency (recruitment, enrollment, retention rates), duration (time between parent consent and assent; survey duration), and barriers to data collection.

Official Title
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Optimizing Residential Treatment Gains for Adolescents Through Tailored Behavioral Parent Training

Conditions
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Parenting, Adolescent - Emotional Problem, Mental Disorder in Adolescence

Intervention / Treatment
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* Behavioral: Parenting Wisely Residential Treatment (PWRT)
* Behavioral: TAU


Participation Criteria
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Eligibility Criteria
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Parent Inclusion Criteria: Caregiver (e.g., biological, step, kin, foster, adoptive) to an adolescent aged 11-17 years old who is admitted to psychiatric residential treatment; The caregiver is allowed contact with the adolescent; Able to speak English; Has access to a device (e.g., smartphone) with internet access. Adolescent Inclusion Criteria: Ability to understand and willingness to provide written assent Legal guardian provides written consent; Currently or previously admitted to psychiatric residential treatment Aged 11-17 years at enrollment; Able to speak English. Parent and Adolescent Exclusion Criteria: Non-English speaking;

Ages Eligible for Study
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Minimum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parenting Wisely Residential Treatment (PWRT)<br>In the PWRT condition, parents will complete a total of ten web-based modules in an online parent training program called Parenting Wisely. Each week, parents will also attend a 90-minute facilitated discussion group via Zoom. Parents will complete assessments at baseline (T1), six weeks post-baseline (T2), and six months post-baseline (T3) via REDCap. While adolescents (n=60) will not directly receive the intervention, they will complete assessments at baseline, six weeks post-baseline (T2), and six months post-baseline (T3). | Behavioral: Parenting Wisely Residential Treatment (PWRT)<br>* PWRT experimental intervention<br>* Other names: PW;|
| Placebo Comparator: Treatment as Usual (TAU)<br>The TAU condition is the standard of care offered to parents in RT settings. Parents in the TAU condition will receive traditional programming, including family therapy offered weekly during the RT admission. Parents will attend discharge planning meetings with caseworkers (if assigned) to discuss the adolescent's progress, continued treatment needs, safety plans, upcoming appointments, and medication needs. Following discharge, programs frequently recommend follow-up with an outpatient provider for medication management and therapy for the adolescent. Parents will complete assessments at baseline (T1), six weeks post-baseline (T2), and six months post-baseline (T3) via REDCap. While adolescents (n=60) will not directly receive the intervention, they will complete assessments at baseline, six weeks post-baseline (T2), and six months post-baseline (T3). | Behavioral: TAU<br>* The TAU condition is the standard of care offered to parents in RT settings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Adolescent Internalizing Behaviors | Adolescent internalizing behaviors will be assessed using the Brief Problem Monitor (BPM) for ages 6 to 18. The BPM consists of 19 items derived from the Child Behavior Checklist. The subscales include internalizing, externalizing, and attention subscales. Raw scores range from 0-38; higher scores indicate greater internalizing behaviors. | Change from baseline to 6-weeks post-baseline | 
| Change in Adolescent Internalizing Behaviors | Adolescent internalizing behaviors will be assessed using the Brief Problem Monitor (BPM) for ages 6 to 18. The BPM consists of 19 items derived from the Child Behavior Checklist. The subscales include internalizing, externalizing, and attention subscales. Raw scores range from 0-38; higher scores indicate greater internalizing behaviors. | Change from baseline to 6-months post-baseline | 
| Change in Adolescent Externalizing Behaviors | Adolescent externalizing behaviors will be assessed using the Brief Problem Monitor (BPM) for ages 6 to 18. The BPM consists of 19 items derived from the Child Behavior Checklist. The subscales include internalizing, externalizing, and attention subscales. Raw scores range from 0-38; higher scores indicate greater externalizing behaviors. | Change from baseline to 6-weeks post-baseline | 
| Change in Adolescent Externalizing Behaviors | Adolescent externalizing behaviors will be assessed using the Brief Problem Monitor (BPM) for ages 6 to 18. The BPM consists of 19 items derived from the Child Behavior Checklist. The subscales include internalizing, externalizing, and attention subscales. Raw scores range from 0-38; higher scores indicate greater externalizing behaviors. | Change from baseline to 6-months post-baseline | 
| Change in Restrictiveness of Living Environment | The Restrictiveness Evaluation Measure (REM) will be administered to evaluate perceptions of adolescent placement restrictiveness. The REM was designed and tested in residential treatment settings. There are two subscales; one scale identifies 25 placement settings varying in restrictiveness and the second subscale consists of questions about the activity and lifestyle restrictions in such placements. Total scores range from 24-120; higher scores indicate more restrictive living environments. | Change from baseline to 6-weeks post-baseline | 
| Change in Restrictiveness of Living Environment | The Restrictiveness Evaluation Measure (REM) will be administered to parents and adolescents to evaluate perceptions of adolescent placement restrictiveness. The REM was designed and tested in residential treatment settings. There are two subscales; one scale identifies 25 placement settings varying in restrictiveness and the second subscale consists of questions about the activity and lifestyle restrictions in such placements. Total scores range from 24-120; higher scores indicate more restrictive living environments. | Change from baseline to 6-months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Family Function | The McMaster Family Assessment Device (FAD) will be administered to parents to evaluate changes in family function. The FAD consists of 60-items that assess seven domains of family function: problem-solving, family roles, communication, affective involvement, affective responsiveness, behavioral control, general functioning. Total scores range from 60-240; higher scores indicate better family function. | Change from baseline to 6-weeks post-baseline | 
| Change in Family Function | The McMaster Family Assessment Device (FAD) will be administered to parents to evaluate changes in family function. The FAD consists of 60-items that assess seven domains of family function: problem-solving, family roles, communication, affective involvement, affective responsiveness, behavioral control, general functioning. Total scores range from 60-240; higher scores indicate better family function. | Change from baseline to 6-months post-baseline | 
| Change in Social Support | The Medical Outcomes Study (MOS) Social Support Survey will be administered to parents to evaluate changes in social support. The MOS consists of 19-items that assess five social support domains: emotional support, informational support, tangible support, affectionate support, and positive social interaction. Total scores range from 20-100; higher scores indicate greater social support. | Change from baseline to 6-weeks post-baseline | 
| Change in Social Support | The Medical Outcomes Study (MOS) Social Support Survey will be administered to parents to evaluate changes in social support. The MOS consists of 19-items that assess five social support domains: emotional support, informational support, tangible support, affectionate support, and positive social interaction.Total scores range from 20-100; higher scores indicate greater social support. | Change from baseline to 6-months post-baseline | 
| Change in Parenting Practices | The Adult-Adolescent Parenting Inventory (AAPI) will be administered to parents to evaluate changes in parenting practices. The AAPI consists of 40-items and is designed for parents of adolescents aged 12 to 17. The AAPI assesses parenting and rearing attitudes and practices. Total scores range from 40-200; higher scores indicate more effective parenting practices. | Change from baseline to 6-weeks post-baseline | 
| Change in Parenting Practices | The Adult-Adolescent Parenting Inventory (AAPI) will be administered to parents to evaluate changes in parenting practices. The AAPI consists of 40-items and is designed for parents of adolescents aged 12 to 17. The AAPI assesses parenting and rearing attitudes and practices. Total scores range from 40-200; higher scores indicate more effective parenting practices. | Change from baseline to 6-months post-baseline | 
| Change in Parenting Self Efficacy | Parents will complete the Parenting Sense of Competence Scale (PSOC) to evaluate changes in parental self-efficacy. The PSOC consists of 17-items and is designed for parents with children aged birth to 17. The two subscales in the PSOC are satisfaction and efficacy. Total scores range from 17-102; higher scores indicate greater perceptions of self-efficacy and confidence. | Change from baseline to 6-weeks post-baseline | 
| Change in Parenting Self Efficacy | Parents will complete the Parenting Sense of Competence Scale (PSOC) to evaluate changes in parental self-efficacy. The PSOC consists of 17-items and is designed for parents with children aged birth to 17. The two subscales in the PSOC are satisfaction and efficacy. Total scores range from 17-102; higher scores indicate greater perceptions of self-efficacy and confidence. | Change from baseline to 6-months post-baseline |