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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR012444 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | OTHER |
| University of Iowa | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
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The purpose of this study is to compare the effectiveness of two parenting programs in a mental health clinic serving young children with behavior problems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Chicago Parent Program arm | Experimental | The Chicago Parent Program is a 12-session group-based parenting skills training program |
|
| Parent-Child Interaction Therapy | Active Comparator | Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chicago Parent Program | Behavioral | The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Child Behavior Problems | parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child. | baseline, first follow-up (up to 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Aggregate Cost | Combined provider (based on billing records) and parent cost (based on self-report). | through end of study (up to 2 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Gross, DNSc | Johns Hopkins University, School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Family Center at Kennedy Krieger Institute | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30768419 | Derived | Gross D, Belcher HME, Budhathoki C, Ofonedu ME, Dutrow D, Uveges MK, Slade E. Reducing Preschool Behavior Problems in an Urban Mental Health Clinic: A Pragmatic, Non-Inferiority Trial. J Am Acad Child Adolesc Psychiatry. 2019 Jun;58(6):572-581.e1. doi: 10.1016/j.jaac.2018.08.013. Epub 2018 Nov 12. | |
| 24581245 | Derived | Gross DA, Belcher HM, Ofonedu ME, Breitenstein S, Frick KD, Chakra B. Study protocol for a comparative effectiveness trial of two parent training programs in a fee-for-service mental health clinic: can we improve mental health services to low-income families? Trials. 2014 Mar 1;15:70. doi: 10.1186/1745-6215-15-70. |
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No data sharing plan was developed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Chicago Parent Program Arm | The Chicago Parent Program is a 12-session group-based parenting skills training program Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems |
| FG001 | Parent-Child Interaction Therapy | Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Chicago Parent Program Arm | The Chicago Parent Program is a 12-session group-based parenting skills training program Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in Child Behavior Problems | parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child. | First follow-up data collected from 42 participants in Chicago Parent Program and 34 participants in Parent-Child Interaction Therapy who started treatment and were discharged, regardless of whether they completed the full treatment. Did not collect follow-up data from remaining participants who enrolled in study but never attended any treatment. | Posted | Mean | Standard Deviation | units on a scale | baseline, first follow-up (up to 2 years) |
|
from the start of treatment until discharge (up to approximately 2 years)
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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 | Intervention Chicago Parent Program Arm | The Chicago Parent Program is a 12-session group-based parenting skills training program Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Gross | Johns Hopkins University | 410-614-5311 | debgross@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2012 | Feb 26, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Parent-Child Interaction Therapy | Behavioral | Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems |
|
| Still in treatment at study end |
|
| Parent-Child Interaction Therapy |
Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Parent-Child Interaction Therapy | Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems |
|
|
| Secondary | Aggregate Cost | Combined provider (based on billing records) and parent cost (based on self-report). | Cost collected for 42 participants in Chicago Parent Program and 34 participants in Parent-Child Interaction Therapy who started treatment and were discharged, regardless of whether they completed the full treatment. Did not collect cost data from the remaining participants who enrolled in study but never attended any treatment. | Posted | Mean | Standard Deviation | dollars | through end of study (up to 2 years) |
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| 0 |
| 81 |
| EG001 | Parent-Child Interaction Therapy | Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems | 0 | 80 | 0 | 80 | 0 | 80 |
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