Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
Efficacy of a Brief Behavioral Intervention to Treat ADHD and Disruptive Behaviors In Preschoolers
Verified date | February 2020 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 29 |
Est. completion date | December 2016 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 5 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06129396 -
Effects of Aerobic Exercise Intervention in Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
|
N/A | |
Completed |
NCT04779333 -
Lifestyle Enhancement for ADHD Program 2
|
N/A | |
Recruiting |
NCT05935722 -
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
|
N/A | |
Completed |
NCT03148782 -
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase
|
N/A | |
Completed |
NCT04832737 -
Strength-based Treatment Approach for Adults With ADHD
|
N/A | |
Recruiting |
NCT04631042 -
Developing Brain, Impulsivity and Compulsivity
|
||
Recruiting |
NCT05048043 -
Development of a Game-supported Intervention
|
N/A | |
Completed |
NCT03337646 -
Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism
|
Phase 4 | |
Not yet recruiting |
NCT06406309 -
Settling Down for Sleep in ADHD: The Impact of Sensory and Arousal Systems on Sleep in ADHD
|
N/A | |
Not yet recruiting |
NCT06454604 -
Virtual Reality Treatment for Emerging Adults With ADHD
|
Phase 2 | |
Not yet recruiting |
NCT06080373 -
Formulation-based CBT for Adult Inmates With ADHD: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT02477280 -
Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance
|
Phase 4 | |
Completed |
NCT02911194 -
a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD)
|
N/A | |
Completed |
NCT02829970 -
Helping College Students With ADHD Lead Healthier Lifestyles
|
N/A | |
Completed |
NCT02473185 -
Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance During the QbTest
|
Phase 4 | |
Completed |
NCT02780102 -
Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD
|
N/A | |
Completed |
NCT02390791 -
New Technologies to Help Manage ADHD
|
N/A | |
Completed |
NCT02555150 -
A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD
|
Phase 3 | |
Recruiting |
NCT04296604 -
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
|
N/A | |
Recruiting |
NCT04175028 -
Neuromodulation of Executive Function in the ADHD Brain
|
N/A |