Efficacy of a Brief Behavioral Intervention to Treat ADHD and Disruptive Behaviors In Preschoolers
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cognitive Studies, Neurology, Psychiatric, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 2 - 5 |
| Updated: | 5/6/2016 |
| Start Date: | December 2012 |
| End Date: | December 2016 |
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).
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.
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.
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.
We found this trial at
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Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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