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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44MH125486-02A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Children's Hope Alliance | UNKNOWN |
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The purpose of this study is to test the effectiveness of a new clinical decision support tool, Placement Success Predictor (PSP), in a naturalistic setting. PSP will provide placement-specific predictions about the likelihood of a youth having a good outcome in each placement type at a behavioral health center using machine learning algorithms.
The primary hypothesis is that clients in at least one placement within one standard deviation of the placement with the highest predicted likelihood of success will have better outcomes than the clients who were not.
The secondary hypothesis is that clients' level of improvement over time will be positively correlated with the number of days they are in at least one placement within one standard deviation of the placement with the highest predicted likelihood of success.
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 effectiveness study is to assess and improve the usage of PSP in a behavioral health setting.
Sample. Clients at Children's Hope Alliance (CHA) who completed the TOP, CHA's standard behavioral health assessment. The target recruitment goal is 700 clients.
Methods. PSP results will be available for all clients with recent behavioral health assessment data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In PSP-Recommended Placement | Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up |
| |
| Not In PSP-Recommended Placement | Clients not in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up |
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| 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. PSP provides site-specific placement success prediction scores [i.e., client's likelihood of success per placement based on machine learning models] for each 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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Clients at Children's Hope Alliance
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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. | ||
| 15546147 | 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. | |
| 37841819 |
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Data were collected from all clients as part of standard clinical practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | In PSP-Recommended Placement, Child Sample | Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up; completed Child version of the behavioral health assessment |
| FG001 | Not In PSP-Recommended Placement, Child Sample | Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up; completed Child version of the behavioral health assessment |
| FG002 | In PSP-Recommended Placement, Adolescent Sample | Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up; completed Adolescent version of the behavioral health assessment |
| FG003 | Not In PSP-Recommended Placement, Adolescent Sample | Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up; completed Adolescent version of the behavioral health assessment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | In PSP-Recommended Placement, Child Sample | Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up |
| BG001 | Not In PSP-Recommended Placement, Child Sample |
| 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 | In PSP-Recommended Placement, Child Sample | Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up |
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Study limitations included: 1) PSP results were delivered during treatment, not pre-treatment. 2) PSP models for two placements did not meet the a priori criteria (AUROC < .70) so PSP results for those placements were not provided. 3) Clinicians had difficulty interpreting PSP results. 4) The study follow-up timeline was short and 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 | May 8, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 23, 2026 | May 8, 2026 | SAP_001.pdf |
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| At baseline (within 2 weeks of study start) and approximately 60-120 days later |
| 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. |
Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up |
| BG002 | In PSP-Recommended Placement, Adolescent Sample | Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up |
| BG003 | Not In PSP-Recommended Placement, Adolescent Sample | Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up |
| 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 |
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| ID | Title | Description |
|---|
| OG000 | In PSP-Recommended Placement, Child Sample | Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up |
| OG001 | Not In PSP-Recommended Placement, Child Sample | Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up |
| OG002 | In PSP-Recommended Placement, Adolescent Sample | Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up |
| OG003 | Not In PSP-Recommended Placement, Adolescent Sample | Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up |
|
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| 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 3 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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| 66 |
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| EG001 | Not In PSP-Recommended Placement, Child Sample | Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up | 0 | 129 | 0 | 129 | 0 | 129 |
| EG002 | In PSP-Recommended Placement, Adolescent Sample | Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up | 0 | 39 | 0 | 39 | 0 | 39 |
| EG003 | Not In PSP-Recommended Placement, Adolescent Sample | Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up | 0 | 169 | 0 | 169 | 0 | 169 |
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