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| ID | Type | Description | Link |
|---|---|---|---|
| R33AT010041 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The purpose of this study is to increase physical activity (PA) in children with ADHD using a novel, family-based intervention that promotes PA within the context of evidence-based behavioral management training (BMT) for caregivers, enhanced with mobile health (mHealth) behavior change strategies.
Primary Objective: To evaluate the primary effects of a 9-week, family-based intervention (Lifestyle Enhancement for ADHD Program - LEAP) to promote PA in young children with ADHD
Secondary: To evaluate secondary effects of the LEAP program on child ADHD symptoms and executive functioning
This is a randomized trial comparing the LEAP program to standard BMT for ADHD (without the enhanced focus on health behaviors, mHealth technology, or social media). Specifically, 80 families will be randomized to receive either LEAP or a standard BMT program based on Russell Barkley's Defiant Children intervention manual. Moderators (e.g., child sex, medication, BMI) and mediators (e.g., change in PA) will be analyzed as exploratory outcomes. Hypotheses being tested include: 1) LEAP will be successful in increasing PA in children with ADHD in the short-term and over a year, more so than standard BPT and 2) children randomized to LEAP will exhibit greater and more sustained improvement in clinical outcomes relative to standard BMT. If successful, the R33 phase will inform the development of a larger and longer, confirmatory trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEAP Group | Experimental | In addition to the components of the BMT group, the LEAP program includes an emphasis on supporting optimal physical activity, limiting screen time, and encouraging adequate sleep. The child and caregiver are also given a wrist-worn activity tracker and caregivers participate in a motivational Facebook group. |
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| BMT Group | Active Comparator | The BMT Group will take part in a family-based intervention within the context of evidence-based behavioral management training (BMT) for caregivers. Standard BMT represents the current standard of care for childhood ADHD. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEAP | Behavioral | LEAP will be delivered through the typical 9 weekly BMT group sessions lasting 90 minutes. Plus wrist worn activity tracker & facebook group. |
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| Measure | Description | Time Frame |
|---|---|---|
| Effects of intervention on Physical Activity | Comparing within-subject pre to post activity (MVPA) using accelerometer data | Baseline to 10 weeks |
| Effects of intervention on Physical Activity | Comparing within-subject pre to post activity (MVPA) using accelerometer data | Baseline to 20 weeks |
| Effects of intervention on Physical Activity | Comparing within-subject pre to post activity (MVPA) using accelerometer data | Baseline to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of LEAP participation on child executive function | Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure | Baseline to 10 weeks |
| Effects of LEAP participation on child executive function |
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Inclusion Criteria (child):
Inclusion Criteria (caregiver):
Inclusion Criteria (supplementary caregiver):
Exclusion Criteria (children):
Exclusion Criteria (caregiver):
- Caregiver participated in an evidence-based parent behavior management training program (i.e., Incredible Years, Triple P, PCIT, Barkley's Defiant Child) in the past 24 months.
Exclusion Criteria (supplementary caregiver): none
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| Name | Affiliation | Role |
|---|---|---|
| Pooja Tandon, MD | Seattle Children's Hospital | Principal Investigator |
| Erin Gonzalez, PHD | Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Research Institute | Seattle | Washington | 98145 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 20, 2024 | |
| Unrelease | Nov 21, 2024 | |
| Release | Nov 21, 2024 | |
| Reset | Dec 16, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 20, 2024 | Nov 21, 2024 | |||
| Nov 21, 2024 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Standard BMT | Behavioral | Weekly BMT groups sessions which follow the Barkley curriculum |
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Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure |
| Baseline to 20 weeks |
| Effects of LEAP participation on child executive function | Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure | Baseline to 1 year |
| Effects of LEAP participation on child ADHD symptoms | Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale | Baseline to 10 weeks |
| Effects of LEAP participation on child ADHD symptoms | Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale | Baseline to 20 weeks |
| Effects of LEAP participation on child ADHD symptoms | Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale | Baseline to 1 year |
| Dec 16, 2024 |