Clinical trial NCT05764369: Optimizing Residential Treatment Gains for Adolescents
Official title: Optimizing Residential Treatment Gains for Adolescents Through Tailored Behavioral Parent Training
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parenting
Adolescent - Emotional Problem
Mental Disorder in Adolescence
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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, dose, and duration. 1b. Evaluate the acceptability of PWRT for parents with adolescents in RT.

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.

Eligibility criteria: 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;
* 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;

Parent and Adolescent Exclusion Criteria:

- Not able to speak English

Primary outcomes:
measure: Group attendance frequency (Feasibility)
timeFrame: Average calculated from baseline to 6-weeks post-baseline
measure: Parenting Wisely login frequency (Feasibility)
timeFrame: Average calculated from baseline to 6-weeks post-baseline
measure: Dose of PWRT (Feasibility)
timeFrame: Average calculated from baseline to 6-weeks post-baseline
measure: Duration of PW modules (Feasibility)
timeFrame: Average calculated from baseline to 6-weeks post-baseline
measure: Duration of group (Feasibility)
timeFrame: Average calculated from baseline to 6-weeks post-baseline
measure: PWRT Acceptability
timeFrame: 6-weeks post-baseline
Secondary outcomes:
measure: Change in Adolescent Internalizing Behaviors
timeFrame: Change from baseline to 6-months post-baseline
measure: Change in Adolescent Internalizing Behaviors
timeFrame: Change from baseline to 6-weeks post-baseline
measure: Change in Adolescent Externalizing Behaviors
timeFrame: Change from baseline to 6-weeks post-baseline
measure: Change in Adolescent Externalizing Behaviors
timeFrame: Change from baseline to 6-months post-baseline
measure: Change in Restrictiveness of Living Environment
timeFrame: Change from baseline to 6-weeks post-baseline
measure: Change in Restrictiveness of Living Environment
timeFrame: Change from baseline to 6-months post-baseline
measure: Change in Family Function
timeFrame: Change from baseline to 6-weeks post-baseline
measure: Change in Family Function
timeFrame: Change from baseline to 6-months post-baseline
measure: Change in Social Support
timeFrame: Change from baseline to 6-weeks post-baseline
measure: Change in Social Support
timeFrame: Change from baseline to 6-months post-baseline
measure: Change in Parenting Practices
timeFrame: Change from baseline to 6-weeks post-baseline
measure: Change in Parenting Practices
timeFrame: Change from baseline to 6-months post-baseline
measure: Change in Parenting Self Efficacy
timeFrame: Change from baseline to 6-weeks post-baseline
measure: Change in Parenting Self Efficacy
timeFrame: Change from baseline to 6-months post-baseline
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University College of Nursing
state: Ohio
Study officials:
References: