NCT06498427

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

3.5 years

First QC Date

June 25, 2024

Last Update Submit

July 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean change on average z-scores from participant self report on Clinical Scale of the Treatment Outcome Package (TOP-CS) over time

    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.

    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.

Secondary Outcomes (4)

  • 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

  • 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.

  • 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

  • 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.

Other Outcomes (1)

  • Cost of treatment

    Through study treatment completion, a maximum of 6 months

Study Arms (2)

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.

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.

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from PRTF and Child ACTT. For example, at Partners MCO in 2020, 131 unique members were served in PRTFs. Their summary demographic characteristics for gender, race, and age were as follows: 43.5 percent female and 55.7 percent male; 18 percent Black, 78 percent White, 3 percent Other and an average age of 14.5 years. Potential primary diagnoses expected are major depressive disorders, psychotic disorders, anxiety disorders, disruptive behavior disorders and bipolar disorder.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outcome Referrals, Inc.

Framingham, Massachusetts, 01701, United States

Location

Related Publications (2)

  • 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.

    PMID: 15546147BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 12, 2024

Study Start

January 4, 2022

Primary Completion

June 20, 2025

Study Completion

June 20, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations