Intervening With Children/Adolescents With FAS/ARND
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | September 12, 2005 | ||||
| Start Date ICMJE | October 2001 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
behavior | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intervening With Children/Adolescents With FAS/ARND | ||||
| Official Title ICMJE | Intervening With Children/Adolescents With FAS/ARND | ||||
| Brief Summary | Children diagnosed through the FAS DPN clinic (who receive non-study services through the clinic/referrals) will receive baseline assessment. The baseline assessment for the child will include: medical issues (including medication), intellectual assessment, academic achievement, language, social functioning, executive functioning, neurological assessment, perceived self-confidence, and behavioral observation of parent-child interactions (videotaped and coded). For caregivers, baseline assessment will include: demographics, medical histories, educational history, current services, satisfaction with services, knowledge of FAS, stress, parenting competence, and family functioning. |
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| Detailed Description | Functional analysis of challenging behaviors will be conducted. Intervention will be an individualized, multimodal, behavioral consultation. The consultation will include: FAS education, emotional/practical support, and teaching child management strategies specific to children with FAS/ARND, advocacy assistance, and school consultation. Specific procedure will be based on previous findings and experience. In particular, specialized “Behavior Support Plans” will be developed for each child with input from parents, teachers, and clinicians. Team consultations at the child’s home during weekly visits. Instruction will include information on FAS, behavioral strategies, and information for advocating with service systems. Evaluation Plan: Both interventions: Treatment and control groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 9-month follow-up (end of school year). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Educational/Counseling/Training |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Positive Behavior Support | ||||
| Study Arm (s) | Not Provided | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 52 | ||||
| Completion Date | June 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - |
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| Gender | Both | ||||
| Ages | 5 Years to 12 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00164528 | ||||
| Other Study ID Numbers ICMJE | CDC-NCBDDD-3752, U84/CCU020163-02 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Centers for Disease Control and Prevention | ||||
| Collaborators ICMJE | University of Washington | ||||
| Investigators ICMJE |
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| Information Provided By | Centers for Disease Control and Prevention | ||||
| Verification Date | September 2005 | ||||
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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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