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Psychosocial Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Type I

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00071656
Recruitment Status : Completed
First Posted : October 30, 2003
Last Update Posted : August 9, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE October 29, 2003
First Posted Date  ICMJE October 30, 2003
Last Update Posted Date August 9, 2013
Study 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 Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Disorder With Hyperactivity
Intervention  ICMJE Behavioral: Psychosocial (behavioral) Intervention
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
60
Original Enrollment  ICMJE Same as current
Actual Study Completion Date June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ADHD, Predominantly Inattentive Type
  • Public or private school attendance
  • English speaking
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 11 Years   (Child)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00071656
Other Study ID Numbers  ICMJE R21MH065927( U.S. NIH Grant/Contract )
R21MH065927 ( U.S. NIH Grant/Contract )
DSIR CT-S
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE Not Provided
PRS Account University of California, San Francisco
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP