Attention Deficit Hyperactivity DisorderNCT01919073
Efficacy of a Brief Behavioral Intervention to Treat ADHD and Disruptive Behaviors In Preschoolers
A study testing Immediate Treatment Group and Delayed Treatment Group in people with Attention Deficit Hyperactivity Disorder and Attention Deficit and Disruptive Behavior Disorders, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Attention Deficit and Disruptive Behavior Disorders
- What is being tested?
- Immediate Treatment Group and Delayed Treatment Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder, Attention Deficit and Disruptive Behavior Disorders
- Being tested
- Immediate Treatment Group, Delayed Treatment Group
- Keywords
- Attention Deficit, ADD, ADHD, ODD, Oppositional Behavior, Disruptive Behavior, Behavior Modification, Parent Management Training, Pre-School
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Attention Deficit and Disruptive Behavior Disorders, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Treatment GroupBehavioural
•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.
Delayed Treatment GroupBehavioural
•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).
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment Group | 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. Receives: Behavioral: Immediate Treatment Group |
| Delayed Treatment Group | 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). Receives: Behavioral: Delayed Treatment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marni Axelrad, Baylor College of Medicine
- Investigators
- Marni Axelrad, Ph.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919073
- Sponsor's protocol ID
- H-31413
- Other IDs
- H-31413
- Status last verified
- Feb 2020
- First submitted
- 6 Aug 2013
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Brief Behavioral Intervention to Treat ADHD and Disruptive Behaviors In Preschoolers
- ClinicalTrials.gov ID
- NCT01919073
- Acronym / sponsor ID
- H-31413
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment Group | Experimental | Behavioral: Immediate Treatment GroupThe 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. |
| Delayed Treatment Group | Active comparator | Behavioral: Delayed Treatment GroupThe 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). |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Immediate Treatment Group |
| 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). | Behavioural | Delayed Treatment Group |
Primary outcome
Parent Behavioral Assessment System for Children- 2nd Edition (BASC2) Externalizing Score
Time frame: 3 months
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.
1 secondary outcome
Improved overall family functioning
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marni Axelrad, Ph.D. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Treatment Group and Delayed Treatment Group in people with Attention Deficit Hyperactivity Disorder and Attention Deficit and Disruptive Behavior Disorders, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Behavioral Assessment System for Children- 2nd Edition (BASC2) Externalizing Score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.