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Optimizing Residential Treatment Gains for Adolescents

Primary Purpose

Parenting, Adolescent - Emotional Problem, Mental Disorder in Adolescence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parenting Wisely Residential Treatment (PWRT)
TAU
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parenting

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Ohio State University College of NursingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Parenting Wisely Residential Treatment (PWRT)

Treatment as Usual (TAU)

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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 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 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 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 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 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.

Secondary Outcome Measures

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 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 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 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 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 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 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 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.

Full Information

First Posted
February 13, 2023
Last Updated
August 31, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT05764369
Brief Title
Optimizing Residential Treatment Gains for Adolescents
Official Title
Optimizing Residential Treatment Gains for Adolescents Through Tailored Behavioral Parent Training
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parenting, Adolescent - Emotional Problem, Mental Disorder in Adolescence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will not know which group they are assigned to, however, study staff will know.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parenting Wisely Residential Treatment (PWRT)
Arm Type
Experimental
Arm Description
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).
Arm Title
Treatment as Usual (TAU)
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Parenting Wisely Residential Treatment (PWRT)
Other Intervention Name(s)
Parenting Wisely, PW
Intervention Description
PWRT experimental intervention
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
The TAU condition is the standard of care offered to parents in RT settings.
Primary Outcome Measure Information:
Title
Change in Adolescent Internalizing Behaviors
Description
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.
Time Frame
Change from baseline to 6-weeks post-baseline
Title
Change in Adolescent Internalizing Behaviors
Description
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.
Time Frame
Change from baseline to 6-months post-baseline
Title
Change in Adolescent Externalizing Behaviors
Description
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.
Time Frame
Change from baseline to 6-weeks post-baseline
Title
Change in Adolescent Externalizing Behaviors
Description
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.
Time Frame
Change from baseline to 6-months post-baseline
Title
Change in Restrictiveness of Living Environment
Description
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.
Time Frame
Change from baseline to 6-weeks post-baseline
Title
Change in Restrictiveness of Living Environment
Description
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.
Time Frame
Change from baseline to 6-months post-baseline
Secondary Outcome Measure Information:
Title
Change in Family Function
Description
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.
Time Frame
Change from baseline to 6-weeks post-baseline
Title
Change in Family Function
Description
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.
Time Frame
Change from baseline to 6-months post-baseline
Title
Change in Social Support
Description
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.
Time Frame
Change from baseline to 6-weeks post-baseline
Title
Change in Social Support
Description
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.
Time Frame
Change from baseline to 6-months post-baseline
Title
Change in Parenting Practices
Description
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.
Time Frame
Change from baseline to 6-weeks post-baseline
Title
Change in Parenting Practices
Description
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.
Time Frame
Change from baseline to 6-months post-baseline
Title
Change in Parenting Self Efficacy
Description
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.
Time Frame
Change from baseline to 6-weeks post-baseline
Title
Change in Parenting Self Efficacy
Description
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.
Time Frame
Change from baseline to 6-months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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; 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kayla Herbel, PhD, RN
Phone
614-688-0959
Email
herbell.3@osu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Solove, MA
Phone
614-247-8366
Email
solove.3@osu.edu
Facility Information:
Facility Name
Ohio State University College of Nursing
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayla Herbell, Phd, RN
Phone
614-688-0959
Email
herbell.3@osu.edu
First Name & Middle Initial & Last Name & Degree
Sandra Solove, MA
Phone
614-247-8366
Email
solove.3@osu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this study will be submitted to the National Institute of Mental Health Data Archive (NDA) at the National Institutes of Health (NIH). If a participant consents to having their data deposited in the NDA, the study team will create a global unique identifier (GUID) using the NDA GUID Tool. The GUID Tool requires a participant's full name, birth date, city of birth, and sex at birth to generate an alphanumeric code that is used to identify a participant across studies. In this study, data that will be deposited will include primary outcomes measures such as The Brief Problem Monitor, the Restrictiveness Evaluation Measure, Parenting Sense of Competence Scale, Adult-Adolescent Parenting Inventory, Medical Outcomes Study Social Support Survey, and McMaster Family Assessment Device. See NDA for more details.
IPD Sharing 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.
IPD Sharing 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.

Learn more about this trial

Optimizing Residential Treatment Gains for Adolescents

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