Psychosocial Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Type I
| Tracking Information | |
|---|---|
| First Received Date ICMJE | October 29, 2003 |
| Last Updated Date | December 7, 2007 |
| Start Date ICMJE | September 2002 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00071656 on ClinicalTrials.gov Archive Site |
| 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 | Psychosocial Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Type I |
| Official Title ICMJE | Psychosocial Treatment for ADHD Inattentive Type I |
| Brief Summary | The purpose of this study is to develop and implement a treatment that focuses on behaviors to reduce symptom severity and functional impairment in patients with Attention Deficit Hyperactivity Disorder, Predominantly Inattentive Type (ADHD-I). The long-term goal of this study is to apply the treatment to larger-scale trials to determine its effectiveness and generalizability. |
| Detailed Description | ADHD-I is a highly prevalent and serious childhood disorder that affects academic and social development. The symptoms of ADHD-I differ from those of the well-studied ADHD Combined Type. Unfortunately, studies of psychosocial interventions for ADHD-I are currently unavailable. Effective treatments for ADHD-I are still needed. Participants are randomly assigned to receive either a behavioral intervention or treatment as usual for 10 to 12 weeks. The behavioral intervention includes parent and child skill development groups, family meetings, and consultation with the child's teacher to address attention problems and areas of impairment at home and school. Parent and child interviews, teacher and child ratings, and psychoeducational testing are used to assess participants. Participants are assessed post-treatment and at a 2-month follow-up visit. |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Condition ICMJE | Attention Deficit Disorder With Hyperactivity |
| Intervention ICMJE | Behavioral: Psychosocial (behavioral) Intervention |
| 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 | 60 |
| Completion Date | June 2007 |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both |
| Ages | 7 Years to 11 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00071656 |
| Other Study ID Numbers ICMJE | R21 MH65927, DSIR CT-S |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Institute of Mental Health (NIMH) |
| Verification Date | December 2007 |
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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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