Overview

This trial is active, not recruiting.

Conditions attention deficit hyperactivity disorder, attention deficit and disruptive behavior disorders
Treatments immediate treatment group, delayed treatment group
Sponsor Baylor College of Medicine
Start date December 2012
End date December 2014
Trial size 29 participants
Trial identifier NCT01919073, H-31413

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
immediate treatment group
•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.
(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).
delayed treatment group
•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).

Primary Outcomes

Measure
Parent Behavioral Assessment System for Children- 2nd Edition (BASC2) Externalizing Score
time frame: 3 months

Secondary Outcomes

Measure
Improved overall family functioning
time frame: 12 months

Eligibility Criteria

Male or female participants from 2 years up to 5 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Additional Information

Official title Efficacy of a Brief Behavioral Intervention to Treat ADHD and Disruptive Behaviors In Preschoolers
Principal investigator Marni Axelrad, Ph.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.