Adolescents' Well-being in Community-based Treatment Versus Residential Treatment
- Conditions
- Adolescent Well-BeingMental Disorders, Severe
- Registration Number
- NCT06498427
- Lead Sponsor
- Outcome Referrals, Inc.
- Brief Summary
This is a quasi-experimental longitudinal study to compare the outcomes of youth in Psychiatric Residential Treatment Facility (PRTF) compared to youth in the at-home Child-Focused Assertive Community Treatment Team \[Child ACTT\] program. The hypothesis is that Child ACTT will be associated with better outcomes and lower cost than PRTF among adolescents admitted to Child ACTT or PRTF.
- 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 ACTT 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
1. The MCO will send a letter to PRTF treatment providers to inform them about this study.
2. CHA and the PRTFs will inform the legal guardians of children who meet the inclusion criteria about a potential study opportunity.
3. 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.
4. 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 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 210
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change on average z-scores from participant self report on Clinical Scale of the Treatment Outcome Package (TOP-CS) over time Baseline completed within 3 weeks of treatment start then a TOP every month up to Month 6 during treatment then at 3 months post-discharge. 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 Disorders, and Suicidality (scores are risk-adjusted for case mix variables assessed via 37 items on the companion TOP-Case Mix form, such as divorce, job loss, comorbidity). Participants indicate "All" to "None of the Time" for each item on a 6-point Likert scale. The z-scores (standard deviation units relative to the general population mean for each domain) will be averaged together to create one summary score. Higher scores suggest higher severity/lower behavioral well-being.
- Secondary Outcome Measures
Name Time Method Satisfaction score most proximal to discharge (up to Month 6) from participant self report on the Overall Provider Quality subscale of the TOP Satisfaction Scale Every month up to Month 6 during treatment The Overall Provider Quality subscale of the TOP Satisfaction Scale assesses patient satisfaction with behavioral health care. 4 Likert scale items about satisfaction with treatment plus single qualitative item (i.e., What are two reasons for your rating of the overall quality of the treatment received?). Scores range between 1 and 6 (higher scores indicate higher satisfaction).
Mean change on the z-score for individual domains from participant self report on the Treatment Outcome Package Baseline completed within 3 weeks of treatment start then a TOP every month up to Month 6 during treatment then at 3 months post-discharge. See Outcome 1 description
Mean change on average z-scores from legal guardian ratings for the participants on the Treatment Outcome Package Baseline completed within 3 weeks of treatment start then a TOP every month up to Month 6 during treatment then at 3 months post-discharge. See Outcome 1 description
Satisfaction score most proximal to discharge (up to Month 6) from legal guardian report on the Overall Provider Quality subscale of the TOP Satisfaction Scale Every month up to Month 6 during treatment See Outcome 2 description
Trial Locations
- Locations (1)
Outcome Referrals, Inc.
🇺🇸Framingham, Massachusetts, United States