Clinical trial NCT01919073: Efficacy of a Brief Behavioral Intervention to Treat ADHD and Disruptive Behaviors In Preschoolers
Official title: Efficacy of a Brief Behavioral Intervention to Treat ADHD and Disruptive Behaviors In Preschoolers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2013-08-08
Enrollment: 29
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Parent Behavioral Assessment System for Children- 2nd Edition (BASC2) Externalizing Score
timeFrame: 3 months
Secondary outcomes:
measure: Improved overall family functioning
timeFrame: 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Marni Axelrad, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: