Optimizing Residential Treatment Gains for Adolescents

NCT05764369 | Completed DMC

• 1 other identifier: 2022B0315
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to determine the feasibility, acceptability, and preliminary effects of a web-based parent training augmented with facilitated parent groups. This hybrid group-based parenting program (called Parenting Wisely for Residential Treatment; 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).

Conditions

Parenting; Adolescent - Emotional Problem; Mental Disorder in Adolescence

Outcome Measures

Primary Outcomes (5)

• Group Attendance (Feasibility)

  The mean number of groups attended by participants.

  Mean calculated at 6-weeks post-baseline

• Module Completion (Feasibility)

  The mean number of modules completed by participants in Parenting Wisely.

  Mean calculated at 6-weeks post-baseline

• Module Duration (Feasibility)

  The mean time participants spent completing one module in Parenting Wisely.

  Mean calculated at 6-weeks post-baseline

• Group Duration (Feasibility)

  The mean amount of time participants spent in a single session of the group.

  Mean calculated at 6-weeks post-baseline

• PWRT Acceptability

  Participants will complete a satisfaction survey to evaluate the acceptability of PWRT. The satisfaction survey consists of 13-items. Total scores range from 0-39; higher scores indicate greater perceptions of acceptability.

  Mean calculated at 6-weeks post-baseline

Secondary Outcomes (12)

• Change in Adolescent Internalizing Behaviors

  Change from baseline to 6-months post-baseline

• Change in Adolescent Internalizing Behaviors

  Change from baseline to 6-weeks post-baseline

• Change in Adolescent Externalizing Behaviors

  Change from baseline to 6-weeks post-baseline

• Change in Adolescent Externalizing Behaviors

  Change from baseline to 6-months post-baseline

• Change in Restrictiveness of Living Environment

  Change from baseline to 6-weeks post-baseline

Study Arms (2)

Parenting Wisely Residential Treatment (PWRT)

EXPERIMENTAL

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)

Treatment as Usual (TAU)

PLACEBO COMPARATOR

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

Interventions

Parenting Wisely Residential Treatment (PWRT) BEHAVIORAL

PWRT experimental intervention

Also known as: Parenting Wisely, PW

Parenting Wisely Residential Treatment (PWRT)

TAU BEHAVIORAL

The TAU condition is the standard of care offered to parents in RT settings.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregiver (e.g., biological, step, kin, foster, adoptive) to an adolescent aged 11-17 years old admitted to psychiatric residential treatment;
• The caregiver is allowed contact with the adolescent;
• Has access to a device (e.g., smartphone) with internet access.
• 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;

You may not qualify if:

• \- Not able to speak English

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University College of Nursing

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Herbell K, Breitenstein SM, Tan A, Melnyk BM, Thai AT, Berger S. Families in transition (FIT) study protocol: feasibility, acceptability and preliminary effects of a group-based parent training in parents of youth in psychiatric residential treatment. BMJ Open. 2024 May 30;14(5):e080603. doi: 10.1136/bmjopen-2023-080603.

  PMID: 38816058 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know which group they are assigned to, however, study staff will know.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 10, 2023
• Study Start: August 31, 2023
• Primary Completion: June 2, 2025
• Study Completion: June 2, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Raw experimental data (both baseline and longitudinal) will not be released/shared until publication or 12 months after the project end date, whichever comes first.
• Access Criteria: The NIH will provide access to scientific investigators for research purposes. Qualified researchers who have completed a Data Use Certification and received approval from the NDA Data Access Committee (DAC) may be approved to access broadly shared data. A separate request process exists for access to data in federated sources. Additionally, the DAC and support staff at NIH have access to NDA shared data.

Locations

US (1)