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

NCT06815562 | Enrolling By Invitation

• 2 other identifiers: 2R44MH125486-02A1-Aim 2A2R44MH125486-02A1
• Study Type: interventional
• Target: 300
• 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 on average z-scores across raters within two weeks on the Clinical Scale of the Treatment Outcome Package (TOP-CS) between a) the beginning of the study (between February and October 2025) and b) approximately 3 months later.

  TOP is a comprehensive well-being assessment that is used in behavioral health and child welfare settings. The Child TOP Clinical Scale (TOP-CS) is a 58-item scale for children (ages 3 - 18) that assesses 13 domains. The Adolescent TOP Clinical Scale (TOP-CS) is a 48-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. 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.

  At baseline and in 3 months

Secondary Outcomes (2)

• Total cost of treatment

  3 months

• Mean difference on average z-scores across raters within two weeks on the TOP-CS between a) the PREDICTED [i.e., risk-adjusted] scores at beginning of the study and b) the ACTUAL follow up scores approximately 3 months later.

  At baseline and in 3 months

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 (2)

• 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

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: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)