- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06498427
Adolescents' Well-being in Community-based Treatment Versus Residential Treatment
A Quasi-experimental Longitudinal Study of Adolescents' Well-being in Community-based Treatment Versus in a Psychiatric Residential Treatment Facility (PRTF)
Study Overview
Status
Conditions
Detailed Description
Psychiatric Residential Treatment Facility (PRTF) care is expensive, removes adolescents from their communities, and is not necessarily effective. Managed care organizations (MCO) are exploring other methods of providing intensive care at home. Several states (e.g., Maine, Minnesota, Florida) have initiated and maintained Youth -Assertiveness Community Treatment (ACT) programs that are adapted from the evidence-based adult ACT model. Children's Hope Alliance (CHA) has been offering the Child-Focused Assertive Community Treatment Team [Child ACTT] Program as a service for potential clients since December 2019.
RECRUITMENT PROCEDURES
- The MCO will send a letter to PRTF treatment providers to inform them about this study.
- CHA and the PRTFs will inform the legal guardians of children who meet the inclusion criteria about a potential study opportunity.
- If the legal guardian verbally consents to being contacted by Outcome Referrals, Inc. (ORI) about the study, CHA or PRTF will forward the contact information for the legal guardian of the eligible participant to ORI via an encrypted email.
- ORI will contact the legal guardian to describe the study and review the eligibility criteria with potential participants (within 5 days of treatment authorization).
Individuals who meet the eligibility criteria and are interested in participating in the study will be sent electronic copies of the assent and consent forms to review and sign. ORI will inform the original referral source (CHA or specific PRTF) if the family is not able to be contacted or does not consent for study.
METHODS AND PROCEDURES
A randomized controlled trial was originally selected as the study design for this project because it is the gold standard for testing for causality; however, given recruitment issues, it was decided to transition to a quasi-experimental study instead. Although the investigators cannot conclude that one treatment is more efficacious than another, this quasi-experimental longitudinal study will provide important comparative information about these two treatment options for high need youth and families.
After study assent and consent forms are received by ORI, ORI will inform the referral source (CHA or PRTF) that the family consented to participate in the study: CHA or the PRTF will provide ORI with the contact information for the case manager at the facility for each participant. ORI will send an email to the case manager to inform them of that client's participation and request a time to train them on study assessment procedures.
ORI will administer a) the electronic assents and consents through an e-signature platform, and b) study assessments to both participants and their legal guardians during and post-treatment through ORI's secure platform, WellnessCheck.net.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Framingham, Massachusetts, United States, 01701
- Outcome Referrals, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Between the ages 12 and 18
- Has primary mental health diagnosis
- Admitted for treatment in a participating program (i.e., Psychiatric Residential Treatment Facility (PRTF) or Child ACTT)
- A trained ORI staff member determines that the youth is able to understand and sign an assent for participation
- Documentation of the youth's assent to participate in the study
- A legal guardian provides consent for the youth to participate in the study
Exclusion Criteria:
- The client is not admitted to treatment in a participating program
- The client has dropped out of this study during a previous treatment episode
- Client does not initiate treatment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Child ACTT - Experimental
Excerpt from the Partners Child ACTT service definition in North Carolina (Revised 5-23-19): Program Requirements: Child ACTT (Assertive Community Treatment Team) is a team-based multi-disciplinary approach to serve children in their homes, kinships placements, foster homes ... The team will have daily meetings to prioritize activities, share information, and discuss individual members. The team will be available to respond 24/7 for crisis de-escalation and assessment, inclusive of availability by phone within 15 minutes and face to face within no more than 2 hours. This will include face-to-face assessment by a clinician, or nurse if this is determined to be needed for the individual. The psychiatric provider will be available minimally by phone 24/7 for consultation and treatment recommendations. The team will assess the overall needs of the family to ensure that all necessary treatment and supports are in place for entire family system. |
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PRTF - Treatment as Usual
Psychiatric Residential Treatment Facilities (PRTFs) are non-hospital facilities intended to provide inpatient services to Medicaid-eligible individuals who are under the age of 21.
A PRTF's mission is to either improve residents' condition or prevent further regression to ultimately remove the need for such services.
PRTFs provide a range of comprehensive services intended to treat residents' psychiatric conditions under the supervision and direction of a psychiatrist.
The core components in a PRTF program include at least weekly medication management, 24 hours nursing services, high staff-to-client ratio with awake staff during night hours, individual, group, and family therapy, intensive psychoeducation, behavioral model of care designed to teach new functional skills, and comprehensive assessments as needed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average Z-score From Participant Self Report on Domains in the Clinical Scale of the Treatment Outcome Package (TOP-CS) at Study Intervention Endpoint
Time Frame: Study intervention endpoint (discharge or 6 months)
|
TOP is a comprehensive well-being assessment that is used in behavioral health and child welfare settings. The Adolescent TOP Clinical Scale (TOP-CS) is a 58-item scale for adolescents who are between the ages of 11 - 21. The TOP-CS assesses the client's past 2-week experience on 12 domains including Depression, Attention Problems, Conduct Problems, and Suicidality. Participants indicate "All" to "None of the Time" for each item on a 6-point Likert scale. The z-scores for each domain were averaged together to create one summary z-score. Summary z-scores range from -0.62 to 11.30 (0 = the general population mean). A higher average domain score suggests higher severity/lower behavioral health well-being. |
Study intervention endpoint (discharge or 6 months)
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|
Average Z-score From Participant Self Report on Domains in the Clinical Scale of the Treatment Outcome Package (TOP-CS) at Post-discharge Follow-up
Time Frame: Completed follow-up within 28 days to 6 months from discharge date during 6- month study intervention
|
TOP is a comprehensive well-being assessment that is used in behavioral health and child welfare settings. The Adolescent TOP Clinical Scale (TOP-CS) is a 58-item scale for adolescents who are between the ages of 11 - 21. The TOP-CS assesses the client's past 2-week experience on 12 domains including Depression, Attention Problems, Conduct Problems, and Suicidality. Participants indicate "All" to "None of the Time" for each item on a 6-point Likert scale. The z-scores for each domain were averaged together to create one summary z-score. Summary z-scores range from -0.62 to 11.30 (0 = the general population mean). A higher average domain score suggests higher severity/lower behavioral health well-being. |
Completed follow-up within 28 days to 6 months from discharge date during 6- month study intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction Score From Participant Self-report on the Overall Provider Quality Subscale of the TOP Satisfaction Scale
Time Frame: At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
|
The Overall Provider Quality subscale of the TOP Satisfaction Scale assesses patient satisfaction with behavioral health care.
It includes 4 Likert scale items about satisfaction with treatment.
Scores range between 1 and 6 (higher scores indicate higher satisfaction).
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At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
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Qualitative Satisfaction Data From Participant Self-report on the Overall Provider Quality Subscale of the TOP Satisfaction Scale
Time Frame: At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
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A single qualitative item (i.e., What are two reasons for your rating of the overall quality of the treatment received?) was included at the end of the Overall Provider Quality subscale of the TOP Satisfaction Scale.
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At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
|
|
Average Z-score From Legal Guardian Ratings on Domains in the Clinical Scale of the Treatment Outcome Package (TOP-CS) at Study Intervention Endpoint
Time Frame: Study intervention endpoint (discharge or 6 months)
|
TOP is a comprehensive well-being assessment that is used in behavioral health and child welfare settings. The Adolescent TOP Clinical Scale (TOP-CS) is a 58-item scale for adolescents who are between the ages of 11 - 21. The TOP-CS assesses the client's past 2-week experience on 12 domains including Depression, Attention Problems, Conduct Problems, and Suicidality. Legal guardians of participants indicated "All" to "None of the Time" for each item for their child on a 6-point Likert scale. The z-scores for each domain were averaged together to create one summary z-score. Summary z-scores range from -0.62 to 11.30 (0 = the general population mean). A higher average domain score suggests higher severity/lower behavioral health well-being. |
Study intervention endpoint (discharge or 6 months)
|
|
Average Z-score From Legal Guardian Ratings on Domains in the Clinical Scale of the Treatment Outcome Package at Post-discharge Follow-up
Time Frame: Completed follow-up within 28 days to 6 months from discharge date during 6- month study intervention
|
TOP is a comprehensive well-being assessment that is used in behavioral health and child welfare settings. The Adolescent TOP Clinical Scale (TOP-CS) is a 58-item scale for adolescents who are between the ages of 11 - 21. The TOP-CS assesses the client's past 2-week experience on 12 domains including Depression, Attention Problems, Conduct Problems, and Suicidality. Legal guardians of participants indicated "All" to "None of the Time" for each item for their child on a 6-point Likert scale. The z-scores for each domain were averaged together to create one summary z-score. Summary z-scores range from -0.62 to 11.30 (0 = the general population mean). A higher average domain score suggests higher severity/lower behavioral health well-being. |
Completed follow-up within 28 days to 6 months from discharge date during 6- month study intervention
|
|
Satisfaction Score From Legal Guardian Report on the Overall Provider Quality Subscale of the TOP Satisfaction Scale
Time Frame: At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
|
The Overall Provider Quality subscale of the TOP Satisfaction Scale assesses patient satisfaction with behavioral health care.
It includes 4 Likert scale items about satisfaction with treatment.
Scores range between 1 and 6 (higher scores indicate higher satisfaction).
|
At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
|
|
Qualitative Satisfaction Data From Legal Guardian Ratings on the Overall Provider Quality Subscale of the TOP Satisfaction Scale
Time Frame: At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
|
A single qualitative item (i.e., What are two reasons for your rating of the overall quality of the treatment received?) was included at the end of the Overall Provider Quality subscale of the TOP Satisfaction Scale.
|
At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
|
|
Z Scores for Individual Domains From Participant Self Report on the Clinical Scale of the Treatment Outcome Package (TOP-CS) at Study Intervention Endpoint
Time Frame: Study intervention endpoint (discharge or 6 months)
|
The Adolescent TOP Clinical Scale (TOP-CS) is a 58-item scale that assesses the client's past 2-week experience on 12 domains. Participants indicate "All" to "None of the Time" for each item on a 6-point Likert scale. Only results for the CONDUCT PROBLEMS domain are presented in the Baseline Characteristics section and below because PRTF scores were significantly improved compared to Child ACTT for this one domain. All other domains (Attention Problems, Depression, Mania, Social Conflict, Worrisome Sexual Behavior, Poor School Functioning, Violence, Substance Abuse, Suicidality, Sleep Problems, Psychosis) showed no significant treatment differences at endpoint after controlling for baseline scores and individual trajectories. Z-scores for the Conduct Problems domain range from -0.20 to 27.01. A z-score of 2 or more standard deviations from 0 (the general population mean) is considered a moderately severe score. |
Study intervention endpoint (discharge or 6 months)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost of Treatment at Study Intervention Endpoint
Time Frame: Through study treatment completion, a maximum of 6 months
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Estimated treatment cost per condition will be assessed by calculating the number of days in treatment times cost per day
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Through study treatment completion, a maximum of 6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kraus DR, Seligman DA, Jordan JR. Validation of a behavioral health treatment outcome and assessment tool designed for naturalistic settings: The Treatment Outcome Package. J Clin Psychol. 2005 Mar;61(3):285-314. doi: 10.1002/jclp.20084.
- Baxter EE, Alexander PC, Kraus DR, Bentley JH, Boswell JF, Castonguay LG. Concurrent validation of the child and adolescent versions of the Treatment Outcome Package (TOP). Journal of Child and Family Studies. 2016; 25(8): 2415-2422.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WCG IRB Protocol #20211997
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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