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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00071656
Other study ID # R21MH065927
Secondary ID R21MH065927DSIR
Status Completed
Phase N/A
First received October 29, 2003
Last updated August 6, 2013
Start date September 2002
Est. completion date June 2007

Study information

Verified date August 2013
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 11 Years
Eligibility Inclusion Criteria:

- ADHD, Predominantly Inattentive Type

- Public or private school attendance

- English speaking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Attention Deficit Disorder With Hyperactivity
  • Hyperkinesis

Intervention

Behavioral:
Psychosocial (behavioral) Intervention


Locations

Country Name City State
United States HALP Clinic, Children's Center at Langley Porter, UCSF San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

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