Clinical Trial: Efficacy of a Brief Behavioral Intervention to Treat ADHD and Disruptive Behaviors In Preschoolers

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Efficacy of a Brief Behavioral Intervention to Treat ADHD and Disruptive Behaviors In Preschoolers

Brief Summary: The purpose of this study is to test the intervention using a more rigorous randomized controlled trial design in order to demonstrate its efficacy compared to a wait-list control, thus ensuring that change in behavior does not occur due to the passage of time alone. Using this design will also allow us to improve upon our prior clinical research by facilitating obtainment of post-treatment and follow-up data (as families in the clinical-only service stop attending treatment when behavior improves, and have often not followed-up for booster sessions or measure completion).

Detailed Summary:

This pilot study will employ a randomized controlled clinical trial design comparing symptoms of children who complete the Brief Behavioral Intervention to a wait-list control. Children in the wait-list control will be waitlisted for four months prior to initiation of treatment, which is a typical wait for clinical care. Treatment will then be offered to the children on the wait-list.

All parts of the intervention and all measures of behavior and family functioning are part of standard clinical care. The parts of this protocol that are not standard clinical care are the following: 1. Randomization process with half of the patients on a waitlist for four months. Randomization will be block randomization stratified by gender. 2. Booster sessions for problem solving at three months and six months after last treatment session. In standard clinical care this occurs only if the patient calls and requests. 3. Collection of behavior and family functioning measures at three months and six months after the active treatment component.


Sponsor: Baylor College of Medicine

Current Primary Outcome: Parent Behavioral Assessment System for Children- 2nd Edition (BASC2) Externalizing Score [ Time Frame: 3 months ]

The primary outcome measure is the parent BASC2 Externalizing score at 3 months post-treatment. The mean score in the control group at 3 months is expected to be about 70 points with a standard deviation of 10 based on previous research. Assuming a 10 unit difference in scores is clinically significant (effect size = 1.0), 17 patients per group will be required to detect a statistically significant difference between groups with 80% power assuming an alpha = 0.05 level of significance.


Original Primary Outcome: Same as current

Current Secondary Outcome: Improved overall family functioning [ Time Frame: 12 months ]

  • The Eyberg Child Behavior Inventory (ECBI) and Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R) will be used to assess oppositional-defiant and conduct problem behaviors, yielding Problem and Intensity scales. The ECBI and SESBI-R were standardized on a large (N=798) sample of children between the ages of 2 and 16 from ethnically diverse backgrounds and exhibit good model fit across ethnic/racial groups. These scales have high internal consistency, good test-retest reliability, good model fit across racial/ethnic groups, enable prediction of membership in referred groups of children, and have good concurrent validity.
  • The Family Adaptability and Cohesion Evaluation Scales IV (FACES-IV) will be used to assess family cohesion and flexibility and has internal reliability and validity over .80 for all scales. The Parenting Stress Index - Short Form will be used to measure stress related to the child's behavior and mood and related to factors specific to the parent.


Original Secondary Outcome: Same as current

Information By: Baylor College of Medicine

Dates:
Date Received: August 6, 2013
Date Started: December 2012
Date Completion: December 2016
Last Updated: May 4, 2016
Last Verified: May 2016