Adolescents' Well-being in Community-based Treatment Versus Residential Treatment

NCT ID: NCT06498427

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 124 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2025-06-20

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.

Conditions

Adolescent Well-Being; Mental Disorders, Severe

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Duke Endowment

OTHER

Sponsor Role: collaborator

Children's Hope Alliance

UNKNOWN

Sponsor Role: collaborator

Outcome Referrals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Outcome Referrals, Inc.

Framingham, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15546147 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

WCG IRB Protocol #20211997

Identifier Type: -

Identifier Source: org_study_id