An interventional study of Immediate Treatment Group and Delayed Treatment Group in Attention Deficit Hyperactivity Disorder and Attention Deficit and Disruptive Behavior Disorders, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2020-02-24.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
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).
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.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's enrollment of 29 is below the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
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Exclusion Criteria:
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
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
•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.
•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).
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.
Time frame: 3 months
Improved overall family functioning
* 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.
Time frame: 12 months
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
Baylor College of Medicine