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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44MH125486-02A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| State of Iowa Department of Health and Human Services | UNKNOWN |
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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.
In 2017, a total of 669,799 children were confirmed victims of maltreatment in the United States; of the 442,733 children in foster care, 34% have been in more than one placement and 11% are in a group home or institution. Stakes are extremely high for making the best out-of-home placement choice per child because some placement types and multiple placements are associated with poor outcomes. In the past few years, legislation has been created to guide placement decisions for children. Federal law 42 U.S. Code 675 requires that children in the care of the state are placed "in a safe setting that is the least restrictive (most family like)." In addition, the Family First Prevention Services Act signed into law by the U.S. Congress in 2018 includes measures to reduce the number of children in long-term residential settings. This study is an effort to develop and test a science-based clinical decision support tool using behavioral health data collected through standard clinical practice.
A randomized controlled trial (RCT) design will be used to assess efficacy of clinical team access to Placement Success Predictor (PSP) on child welfare clients' well-being outcomes and healthcare costs.
Sample. Clients at the State of Iowa Department of Health and Human Services (Iowa HHS) are the sample for this efficacy study.
Randomization. The outcome of a single coin toss was applied to an undisclosed algorithm for the client's record number to determine who gets assigned to the experimental group (i.e., client has PSP results).
Methods. The Treatment Outcome Package (TOP), a behavioral health assessment, is a standard part of care delivered in Iowa and its completion is required by the state. Iowa HHS clinical teams were provided PSP results for clients in the experimental condition. A request for a waiver of consent for this study was approved by the WCG IRB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| No PSP site-specific placement prediction scores for that youth | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 behavioral health domains. Participants answer "All" to "None of the Time" for each item on a 6-point Likert scale. The TOP-CS Total Score is computed by averaging item responses. The range is 48 to 288 for the Child TOP-CS and 56 to 336 for the Adolescent TOP-CS. Higher Total Scores represent better behavioral well-being (a better outcome). Total Scores are averaged across raters per participant. The value reported is the mean difference between each participant's model-predicted, risk-adjusted Total Score (the outcome expected given their baseline profile) and their actual observed Total Score at follow-up. A positive mean difference indicates that the actual follow-up outcome exceeded the model-predicted outcome (i.e., the participant did better than predicted). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outcome Referrals, Inc. | Framingham | Massachusetts | 01701 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 37841819 | 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. | |
| 15546147 |
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Data were collected from all clients as part of standard clinical practice. Only clients with valid data at baseline and follow-up were included in these samples.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental, Child Sample | The system provides site-specific placement success prediction (PSP) 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. |
| FG001 | Control, Child Sample | No site-specific placement success prediction (PSP) scores were generated. |
| FG002 | Experimental, Adolescent Sample | The system provides site-specific placement success prediction (PSP) 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. |
| FG003 | Control, Adolescent Sample | No site-specific placement success prediction (PSP) scores were generated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental, Child Sample | The system provides site-specific placement success prediction (PSP) 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. Client completed Child version of the behavioral health assessment. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | Z-score | At baseline (within 2 weeks of study start) and approximately 60-120 days later |
From enrollment until end of follow-up, up to 4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental, Child Sample | The system provides site-specific placement success prediction (PSP) 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberlee J. Trudeau, Ph.D. | Outcome Referrals, Inc. | 5088347323 | kimberlee.trudeau@outcomereferrals.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2023 | Apr 6, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 23, 2026 | May 6, 2026 | SAP_001.pdf |
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Efficacy (randomized clinical trial) study
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| At baseline (within 2 weeks of study start) and approximately 60-120 days later |
| 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. |
| Control, Child Sample |
No site-specific placement prediction success (PSP) scores were generated. Client completed Child version of the behavioral health assessment. |
| BG002 | Experimental, Adolescent Sample | The system provides site-specific placement success prediction (PSP) 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. Client completed Adolescent version of the behavioral health assessment. |
| BG003 | Control, Adolescent Sample | No site-specific placement prediction success (PSP) scores were generated. Client completed Adolescent version of the behavioral health assessment. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Experimental, Child Sample | The system provides site-specific placement success prediction (PSP) 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. |
| OG001 | Control, Child Sample | No site-specific placement prediction success (PSP) scores were generated. |
| OG002 | Experimental, Adolescent Sample | The system provides site-specific placement success prediction (PSP) 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. |
| OG003 | Control, Adolescent Sample | No site-specific placement prediction success (PSP) scores were generated. |
|
|
| Secondary | 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 | 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 behavioral health domains. Participants answer "All" to "None of the Time" for each item on a 6-point Likert scale. The TOP-CS Total Score is computed by averaging item responses. The range is 48 to 288 for the Child TOP-CS and 56 to 336 for the Adolescent TOP-CS. Higher Total Scores represent better behavioral well-being (a better outcome). Total Scores are averaged across raters per participant. The value reported is the mean difference between each participant's model-predicted, risk-adjusted Total Score (the outcome expected given their baseline profile) and their actual observed Total Score at follow-up. A positive mean difference indicates that the actual follow-up outcome exceeded the model-predicted outcome (i.e., the participant did better than predicted). | The overall #s of participants analyzed for the secondary outcome is smaller than the #s of participants in the Overall Study because a TOP Total Score was not available for 5 participants due to missing item-level data. | Posted | Mean | Standard Deviation | Score on a scale | At baseline (within 2 weeks of study start) and approximately 60-120 days later |
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| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Control, Child Sample | No site-specific placement prediction success (PSP) scores were generated. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | Experimental, Adolescent Sample | The system provides site-specific placement success prediction (PSP) 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. | 0 | 76 | 0 | 76 | 0 | 76 |
| EG003 | Control, Adolescent Sample | No site-specific placement prediction success (PSP) scores were generated. | 0 | 75 | 0 | 75 | 0 | 75 |
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