Effectiveness of School- and Home-Based Mental Health Services in Improving Learning and Behavior in Children in Urban Schools
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 22, 2008 | ||||||||
| Last Updated Date | March 12, 2009 | ||||||||
| Start Date ICMJE | June 2005 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Disruptive school behavior [ Time Frame: Measured at pre- and post-school year for 3 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00612690 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Academic performance [ Time Frame: Measured at pre- and post-school year for 3 years ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effectiveness of School- and Home-Based Mental Health Services in Improving Learning and Behavior in Children in Urban Schools | ||||||||
| Official Title ICMJE | Mental Health Services & Predictors of Learning in Urban Schools | ||||||||
| Brief Summary | This study will evaluate the effectiveness of school- and home-based mental health services and training modules in supporting learning and behavior in financially disadvantaged children who live in urban areas. |
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| Detailed Description | There are an estimated 4.5 to 6.3 million children with mental disorders in the United States. Emotional and behavioral problems associated with childhood mental disorders have a significant impact, with affected children at an increased risk of reduced quality of life and school dropout. If left untreated, childhood mental disorders may continue into adulthood, often impairing ability to function as an adult. It is believed that, compared to clinic-based services, school- and home-based mental health services may lead to greater improvements in children's learning and behavior at school and home. Especially important to this type of approach is a collaborative effort among parents, teachers, and children to encourage and maintain positive behaviors and academic performance both at home and in the classroom. This study will evaluate the effectiveness of school- and home-based mental health services and training modules in supporting learning and behavior in financially disadvantaged children who live in urban areas. This 3-year study will involve parent, child, and teacher participants. During Year 1, teacher participants will attend a professional development series that will focus on strategies that classroom teachers can use to help children with learning and behavior problems at school. The series will involve weekly 30-minute sessions, which will be held before and after school hours, for a total of 6 months. Teachers will fill out a brief survey about the content and structure of sessions at the end of each session and will give a monthly review on how they are applying their new strategies in the classroom setting. Teachers will continue to attend booster sessions of up to 1 hour each month during Year 2. Teachers will also participate in periodic case consultation meetings with parents and mental health providers to further develop ways to improve student participants' learning and behavior. Child participants will either undergo the community mental health program associated with their school or receive general clinic-based services. The school component of the mental health program will consist of a classroom environment in which the teachers implement their newly learned strategies. The teachers will aim to enhance the academic and behavioral performance of the child participants. Parents of child participants in the community mental health program will be invited to attend a series of parent/teacher meetings and home visits where mental health service providers will discuss strategies that parents and teachers can use to help improve their children's learning and behavior. Parents will fill out a brief questionnaire at the end of each meeting and will give a monthly review of how they are implementing their new strategies in the home setting. Parents will continue to communicate with research staff regarding services provided throughout the study. Assessments for all participants will occur five times over 3 years. Assessments for parent participants will include questions about their child's behavior at school and home, their child's use of mental health services, involvement in their child's schooling, and possible stresses in life. Assessments for teachers will include questions about the behavior and academic performances of the child participants, parent involvement with the children's schooling, and stresses in their work environment. A research staff member will also conduct a 2-hour classroom observation five times over 3 years. Individual child participants will also be observed in the classroom by research staff for three 15-minute intervals five times over the study period. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1200 | ||||||||
| Estimated Completion Date | May 2010 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 5 Years to 12 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00612690 | ||||||||
| Other Study ID Numbers ICMJE | R01 MH073749, DSIR 82-SECHC | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Eric Gislason, PhD, Board of Trustees of the University of Illinois | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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