Effectiveness of a Behavioral Treatment Program for Attention Deficit Hyperactivity Disorder, Inattentive Type
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| First Received Date ICMJE | February 2, 2009 | ||||||||||||
| Last Updated Date | June 20, 2012 | ||||||||||||
| Start Date ICMJE | November 2008 | ||||||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Inattention symptoms, as defined by the DSM-IV [ Time Frame: Measured immediately post-treatment and at a follow-up 5 to 7 months later ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00834821 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
Academic and social functioning [ Time Frame: Measured immediately post-treatment and at a follow-up 5 to 7 months later ] [ 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 a Behavioral Treatment Program for Attention Deficit Hyperactivity Disorder, Inattentive Type | ||||||||||||
| Official Title ICMJE | Integrated Multi-setting Psychosocial Treatment for ADHD-Inattentive Type | ||||||||||||
| Brief Summary | This study will test the effectiveness of a new behavioral treatment, called the Child Life and Attention Skills Program, for children with attention deficit hyperactivity disorder, inattentive type. |
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| Detailed Description | Attention deficit hyperactivity disorder (ADHD) is a common childhood disorder in which problems with focusing disrupt a normal life. There are two subtypes of ADHD: combined type (ADHD-C), which includes symptoms of inattention and hyperactivity or impulsivity, and inattentive type (ADHD-I), in which symptoms are limited to inattention. The profile of ADHD-I, including attention deficits, comorbid disorders, social impairments, and neurocognitive functioning, is sufficiently different from the profile of ADHD-C that treatments effective for ADHD-C may not also be effective in treating ADHD-I. Most studies of ADHD treatment evaluate ADHD-C, and there is very little research into treatments aimed specifically at ADHD-I. The Child Life and Attention Skills (CLAS) Program is a behavioral program designed specifically for ADHD-I and combines life skills training for the child, teacher consultation, and parent training techniques adapted from ADHD-C treatments. This study will compare the effectiveness of the CLAS Program, standard parent training, and community referrals in treating children with ADHD-I. Participation in this study will last 11 to 12 weeks, followed by a 5- to 7-month follow-up period. On the basis of parent and teacher evaluations of each child's behavior, invitations to participate in screening procedures for the study will be extended to children and their parents. There will be two screening visits, during which the child will undergo reviews of medical and developmental history, diagnostic interviews, intelligence testing, academic achievement testing, and neuropsychological testing. The child and parent will be videotaped in a series of interactions, and both will complete questionnaires about child functioning, parent functioning, family functioning, and family relations. The child's teacher and school principal will also be contacted to ensure that they are willing to participate in the study. Eligible participants will then be randomly assigned to receive the CLAS Program, parent-focused training (PFT), or community referrals. The CLAS Program will involve a half-hour orientation and up to five half-hour weekly meetings with the child's teacher, therapist, and parent over 11 to 12 weeks. The program will also involve ten 1.5-hour group sessions for parents, with separate group sessions for children at the same time, and up to five individual family sessions led by a therapist. Teachers will participate in a school-home note system for maintaining and rewarding child behavior; parents will be taught strategies for giving commands, using rewards and consequences, and establishing routines and organizational schemes; and children will be taught social interaction skills, homework skills, and organizational skills. Participants in the PFT group will attend the ten 1.5-hour parent group sessions and up to five individual family sessions. Participants in the community referrals group will only receive referrals to community mental health practitioners. All participants will undergo assessments that are similar to those in the screening visit after completing treatment and again at a follow-up visit 5 to 7 months later. Participants in the CLAS and PFT groups will continue monthly individual family sessions with a therapist until undergoing the follow-up assessment. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Attention Deficit Disorder With Hyperactivity | ||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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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 | Active, not recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 210 | ||||||||||||
| Estimated Completion Date | June 2013 | ||||||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion 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 | NCT00834821 | ||||||||||||
| Other Study ID Numbers ICMJE | R01 MH077671, R01MH077671, DSIR 84-CTS | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | University of California, San Francisco | ||||||||||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||||||||||
| Verification Date | June 2012 | ||||||||||||
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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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