Predict the Best Level of Care Placement for Each Child's Behavioral Health Needs - Efficacy Study

NCT06815562 | Completed Results

• 2 other identifiers: 2R44MH125486-02A1-Aim 2A2R44MH125486-02A1
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized clinical trial is to test the efficacy of a new clinical decision support tool, Placement Success Predictor (PSP). PSP will provide placement-specific predictions about the likelihood of a youth having a good outcome in each placement type using machine learning algorithms. The primary hypothesis is that if clinical team members have access to PSP results for youth in the experimental group, these youth will have better outcomes at the 3-month follow-up compared to youth in the control group.

Conditions

Adolescent Well-Being; Mental Health Wellness

Outcome Measures

Primary Outcomes (1)

• Mean Difference in Average Domain Z-scores Across Raters Within Two Weeks on the Clinical Scale of the Treatment Outcome Package (TOP-CS) Between a) Baseline and b) Follow-up.

  The Child Treatment Outcome Package (TOP-CS) is a 48-item scale for children (ages 3 - 18) that assesses 13 domains. The Adolescent TOP-CS is a 58-item scale for adolescents (ages 11 - 21) that assesses 12 domains. TOP-CS assesses the client's past 2-week experience on domains including Depression, Violence, and Suicidality (scores are risk-adjusted for case mix variables assessed via 37 items on the companion TOP-Case Mix form regarding stressful life events, comorbidity). Participants answer "All" to "None of the Time" for each item on a 6-point Likert scale. A domain z-score of 0 represents the general population mean. Domain z-scores are averaged into a summary score per participant. Higher (more positive) average z-scores indicate greater symptom severity and lower behavioral well-being (a worse outcome). The value reported is the mean difference in this average z-score between baseline and follow-up; a negative mean difference indicates improvement (reduced severity).

  At baseline (within 2 weeks of study start) and approximately 60-120 days later

Secondary Outcomes (1)

• Mean Difference Between the Average Risk-adjusted Predicted TOP-CS Total Score Across Raters at Study Baseline and the Actual Average TOP-CS Total Score Across Raters at Follow-up

  At baseline (within 2 weeks of study start) and approximately 60-120 days later

Study Arms (2)

Access to PSP site-specific placement prediction scores for that youth

EXPERIMENTAL

The PSP system will provide site-specific placement success prediction scores \[i.e., client's likelihood of success per placement based on machine learning models\] for each youth randomized to this condition in the efficacy study.

Other: Clinical team access to Placement Success Predictor (PSP) results

No PSP site-specific placement prediction scores for that youth

NO INTERVENTION

Interventions

Clinical team access to Placement Success Predictor (PSP) results OTHER

PSP is a machine-learning based clinical decision support tool that is designed to assist clinical team members in making placement decisions for youth.

Access to PSP site-specific placement prediction scores for that youth

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Completed TOP CS assessment

You may not qualify if:

• None

Sponsors & Collaborators

• Outcome Referrals, Inc.: lead
• National Institute of Mental Health (NIMH): collaborator
• State of Iowa Department of Health and Human Services: collaborator

Study Sites (1)

Outcome Referrals, Inc.

Framingham, Massachusetts, 01701, United States

Location

Related Publications (3)

• Baxter, E. E., Alexander, P. C., Kraus, D. R., Bentley, J. H., Boswell, J. F., & Castonguay, L. G. (2016). Concurrent validation of the Treatment Outcome Package (TOP) for children and adolescents. Journal of Child and Family Studies, 25, 2415-2422.

  BACKGROUND

• Trudeau KJ, Yang J, Di J, Lu Y, Kraus DR. Predicting Successful Placements for Youth in Child Welfare with Machine Learning. Child Youth Serv Rev. 2023 Oct;153:107117. doi: 10.1016/j.childyouth.2023.107117. Epub 2023 Aug 4.

  PMID: 37841819 BACKGROUND

• 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: 15546147 BACKGROUND

Limitations and Caveats

Potential limitations of this study include: 1) The timing of the results: PSP results were delivered during treatment, not pre-treatment; 2) Contentment: Many clients were doing well in their current placement; 2) Incorrect target audience: PSP notifications were provided to assigned caseworkers who were unlikely to be the placement decision makers; and 3) The short study follow-up timeline: Moving youth to new placements is time, resource, and emotionally-intensive.

Results Point of Contact

• Title: Kimberlee J. Trudeau, Ph.D.
• Organization: Outcome Referrals, Inc.

kimberlee.trudeau@outcomereferrals.com

5088347323

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Efficacy (randomized clinical trial) study

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 7, 2025
• Study Start: February 3, 2025
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: July 8, 2026
• Results First Posted: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)