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

NCT01919073 | Completed

• 1 other identifier: H-31413
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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).

Conditions

Attention Deficit Hyperactivity Disorder; Attention Deficit and Disruptive Behavior Disorders

Keywords

Attention Deficit, ADD, ADHD, ODD, Oppositional Behavior, Disruptive Behavior, Behavior Modification, Parent Management Training, Pre-School

Outcome Measures

Primary Outcomes (1)

• Parent Behavioral Assessment System for Children- 2nd Edition (BASC2) Externalizing Score

  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.

  3 months

Secondary Outcomes (1)

• Improved overall family functioning

  12 months

Study Arms (2)

Immediate Treatment Group

EXPERIMENTAL

The immediate treatment group will fill out the questions at the initial appointment and again after five treatment appointments. They will fill the questions out again at the first follow-up treatment appointment (approximately 4-5 months from the initial appointment), and then at the next (and last) follow-up appointment (approximately 7-8 months). The participants teacher will also be asked to fill out sets of questions.

Behavioral: Immediate Treatment Group

Delayed Treatment Group

ACTIVE COMPARATOR

The wait list group will fill out the sets of questions again in 1-2 months. The question sets will then be completed again before beginning treatment four months from the initial completion and then again after five treatment appointments. The question sets will then be completed again at the first follow-up treatment appointment (approximately 8-9 months from the initial appointment) and at the next (and last) follow-up appointment (in about 11-12 months from the initial appointment).

Behavioral: Delayed Treatment Group

Interventions

Immediate Treatment Group BEHAVIORAL

•The immediate treatment group will fill out the questions at the initial appointment and again after five treatment appointments. They will fill the questions out again at the first follow-up treatment appointment (approximately 4-5 months from the initial appointment), and then at the next (and last) follow-up appointment (approximately 7-8 months). The participants teacher will also be asked to fill out sets of questions.

Immediate Treatment Group

Delayed Treatment Group BEHAVIORAL

•The wait list group will fill out the sets of questions again in 1-2 months. The question sets will then be completed again before beginning treatment four months from the initial completion and then again after five treatment appointments. The question sets will then be completed again at the first follow-up treatment appointment (approximately 8-9 months from the initial appointment) and at the next (and last) follow-up appointment (about 11-12 months from the initial appointment).

Delayed Treatment Group

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 2-5 years
• Subject diagnosed with a Disruptive Behavior Disorder
• Subject who has an English-speaking parent willing to take part in intervention.
• Subject must meet criteria for a Diagnostic and Statistical Manual (DSM-IV) Disruptive Behavior Disorder (ADHD and/or ODD) based upon history, clinical interview, and clinically significant cut-off scores on parent rating forms. Parent and teacher of each child will also be involved.

You may not qualify if:

• Parents who are not fluent in English
• Subjects with a diagnosed anxiety disorder, pervasive developmental disorder, intellectual disability, adjustment disorder, mood disorder or language disorder will also be excluded and referred for more appropriate services.
• Children with less severe behavior problems will not be included in the study but will be referred for more appropriate services.
• Patients taking medication to treat behavior and patients who have previously received treatment will be excluded from the study.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders; Problem Behavior

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• Marni Axelrad, Ph.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 8, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

US (1)