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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01161719
Other study ID # 200816003
Secondary ID
Status Completed
Phase N/A
First received June 25, 2010
Last updated January 25, 2016
Start date April 2008
Est. completion date June 2009

Study information

Verified date January 2016
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of group parent training taught through videoconferencing on ADHD treatment via a comparison between participants using traditional face-to-face parent training sessions and a group using teleconferencing.


Description:

Subjects with a primary diagnosis of ADHD between the ages of 6 and 14 years were enrolled. All subjects were screened and assessed for psychiatric and learning disorders using structured interviews (DICA, parent and child version, Reich et al, 2000) based on DSM IV criteria and parent and teacher rating scales. Mothers took the Beck Depression Inventory (BDI) to assess for depression.

Parents or primary caregivers were randomized to two treatment arms (videoconference or face to face). Ten sessions of weekly parent training through either videoconference or face-to-face delivery was conducted using Dr. Russell A. Barkley's manual. A non-mandatory skill training and play group was offered to the children of both groups while parents attended the parent training group in order to provide child care for the parents during the training sessions.

Following outcomes will be measured to assess the effectiveness of the intervention:

Primary outcome Acceptance of the parent and children on the mode the communication as well as parent training.

Secondary outcomes:

1. Parent-child relations measured by the Parent Child Relationship Questionnaire (PCQ)

2. The Vanderbilt Assessment Scale (parent & teacher versions), Children Global Assessment Scale (CGAS), Clinical Global Impression- Severity score (CGI-S), and Clinical Global Impression-Improvement Scores (CGI-I) assessed the severity of core symptoms of ADHD and oppositional/aggressive symptoms.

3. The parent and teacher-rated versions of the Social Skills Rating System (SSRS) assessed social skills.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 14 Years
Eligibility Inclusion Criteria:

- DSM-IV criteria for any subtype of ADHD.

- ADHD must be the primary diagnosis if there is comorbidity.

Exclusion Criteria:

- Subjects with significant medical conditions, which are not stable on current outpatient treatment regimen.

- Subjects with severe psychiatric disorders (i.e., bipolar disorder, autism, schizophrenia, major depression).

Study Design

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


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Hyperkinesis

Intervention

Behavioral:
parent training
Behavioral management skill training

Locations

Country Name City State
United States UC Davis MIND Institute Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptance of the parent and children on the mode the communication as well as parent training Acceptance of the parent and children on the mode the communication as well as parent training will be measured by a Likert scale, which is a 12 intem questionaire to assess parent's satisfaction with the intervention. One year No
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