ParentingNCT05764369
Optimizing Residential Treatment Gains for Adolescents
A study testing Parenting Wisely Residential Treatment (PWRT) and TAU in people with Parenting and Adolescent - Emotional Problem, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Parenting, Adolescent - Emotional Problem, Mental Disorder in Adolescence
- What is being tested?
- Parenting Wisely Residential Treatment (PWRT) and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2023to 2 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Parent Inclusion Criteria:
- 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.
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University College of Nursing
Columbus, Ohio, 43210
About this study
Official title: Optimizing Residential Treatment Gains for Adolescents Through Tailored Behavioral Parent Training
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).
Read the 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.
- Being tested
- Parenting Wisely Residential Treatment (PWRT), TAU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting Wisely Residential Treatment (PWRT)Behavioural
Also called Parenting Wisely, PW
PWRT experimental intervention
TAUBehavioural
The TAU condition is the standard of care offered to parents in RT settings.
| Study group | Role | What they receive |
|---|---|---|
| Parenting Wisely Residential Treatment (PWRT) - Parents | 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).This arm includes only parent respondents. Receives: Behavioral: Parenting Wisely Residential Treatment (PWRT) |
| Treatment as Usual (TAU) - Parents | 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). This arm includes only parent respondents. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group Attendance (Feasibility)
The mean number of groups attended by parent participants in the PWRT arm.
Measured: Mean calculated at 6-weeks post-baseline
Group Duration (Feasibility)
The mean amount of time parent participants spent in a single session of the group.
Measured: Mean calculated at 6-weeks post-baseline
Module Duration (Feasibility)
The mean time parent participants spent completing one module in Parenting Wisely.
Measured: Mean calculated at 6-weeks post-baseline
Module Completion
Average number of modules parent participants completed over a 6 week intervention period
The mean number of Modules participants completed in Parenting Wisely.
Measured: Mean calculated at 6-weeks post-baseline
Secondary outcomes (3)
Brief Problem Monitor (BPM) - Internalizing Behaviors
Adolescent internalizing behaviors will be assessed using the Brief Problem Monitor (BPM) for ages 6 to 18. There are two subscales on the BPM: internalizing and externalizing subscales. There are six items on the internalizing subscale with scores ranging from 0-12. Higher scores indicate greater internalizing behaviors, therefore worse outcomes.
Change over time in the outcome measure is assessed by subtracting mean values at T1 from mean values at T2 and T3 respectively.
Measured: Baseline, 6 weeks, 6 months; Change from baseline to 6 weeks; Change from baseline to 6-months post
Brief Problem Monitor (BPM) - Externalizing Behaviors
Adolescent externalizing behaviors will be assessed using the Brief Problem Monitor (BPM) for ages 6 to 18. There are two subscales on the BPM: internalizing and externalizing subscales. There are seven items on the externalizing subscale with scores ranging from 0-14. Higher scores indicate greater externalizing behaviors, therefore worse outcomes.
Change over time in the outcome measure is assessed by subtracting mean values at T1 from mean values at T2 and T3 respectively.
Measured: Baseline, 6 weeks, 6 months; Change from baseline to 6 weeks; Change from baseline to 6-months post
Brief Problem Monitor (BPM) - Total Score
Total adolescent behavior problems 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 total score includes internalizing, externalizing and inattention subscales which are summed. Internalizing behaviors is 6 items with scores ranging from 0-12, Externalizing is 7 items with scores ranging from 0-14, Inattention is 6 items with scores ranging from 0-12. Raw scores range from 0-38; higher scores indicate greater total behavior problems thereby worse outcomes. Change over time in the outcome measure is assessed by subtracting mean values at T1 from mean values at T2 and T3 respectively.
Measured: Baseline, 6 weeks, 6 months; Change from baseline to 6 weeks; Change from baseline to 6-months post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start31 Aug 2023
- Primary completion2 Jun 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kayla Herbell, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764369
- Sponsor's protocol ID
- 2022B0315
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2023
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38816058
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Residential Treatment Gains for Adolescents Through Tailored Behavioral Parent Training
- ClinicalTrials.gov ID
- NCT05764369
- Acronym / sponsor ID
- 2022B0315
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Posted 31 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenting Wisely Residential Treatment (PWRT) - Parents | Experimental | Behavioral: Parenting Wisely Residential Treatment (PWRT)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).This arm includes only parent respondents. |
| Treatment as Usual (TAU) - Parents | Placebo comparator | Behavioral: TAUThe 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). This arm includes only parent respondents. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenting Wisely Residential Treatment (PWRT)Also: Parenting Wisely, PWPWRT experimental intervention | Behavioural | Parenting Wisely Residential Treatment (PWRT) - Parents |
| TAUThe TAU condition is the standard of care offered to parents in RT settings. | Behavioural | Treatment as Usual (TAU) - Parents |
Primary outcome
Group Attendance (Feasibility)
Time frame: Mean calculated at 6-weeks post-baseline
The mean number of groups attended by parent participants in the PWRT arm.
Group Duration (Feasibility)
Time frame: Mean calculated at 6-weeks post-baseline
The mean amount of time parent participants spent in a single session of the group.
Module Duration (Feasibility)
Time frame: Mean calculated at 6-weeks post-baseline
The mean time parent participants spent completing one module in Parenting Wisely.
Module Completion
Time frame: Mean calculated at 6-weeks post-baseline
Average number of modules parent participants completed over a 6 week intervention period The mean number of Modules participants completed in Parenting Wisely.
3 secondary outcomes
Brief Problem Monitor (BPM) - Internalizing Behaviors
Time frame: Baseline, 6 weeks, 6 months; Change from baseline to 6 weeks; Change from baseline to 6-months post
Brief Problem Monitor (BPM) - Externalizing Behaviors
Time frame: Baseline, 6 weeks, 6 months; Change from baseline to 6 weeks; Change from baseline to 6-months post
Brief Problem Monitor (BPM) - Total Score
Time frame: Baseline, 6 weeks, 6 months; Change from baseline to 6 weeks; Change from baseline to 6-months post
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38816058Herbell 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting Wisely Residential Treatment (PWRT) and TAU in people with Parenting and Adolescent - Emotional Problem, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group Attendance (Feasibility) (time frame: Mean calculated at 6-weeks post-baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05764369, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.