Mindfulness-Based ADHD Treatment for Children: a Feasibility Study
Completed · Early Phase 1
Conditions studied: Attention Deficit Hyperactivity Disorder
In brief
Attention-Deficit/Hyperactivity Disorder (ADHD) affects 11% of children and leads to adverse outcomes. Medications, while often effective in reducing certain ADHD symptoms, have many disadvantages, including misuse and side effects. Behavioral interventions do not have these adverse effects, but they are not as effective. Mindfulness is a candidate intervention for ADHD in elementary school children, but has not been systematically and rigorously studied. This study will evaluate the feasibility and acceptability of Mindfulness-Based ADHD Treatment for Children (MBAT-C). MBAT-C is designed for children at precisely the age when ADHD-relevant neurocognitive systems are developing and clinical symptoms begin to appear. Forty-five children from the New Haven, CT area, ages 7-13, will be recruited to participate in this randomized-controlled feasibility trial that will compare MBAT-C, medication, and a combined intervention.
Key facts
- Study ID
- NCT04737512
- Run by
- Yale University
- People needed
- 68
- Starts
- 2021-02-01
- Expected to finish
- 2024-10-29
- Last updated by the study team
- 2024-11-25
Who can join
Age: 7 and older, up to 13. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- child of any sex/gender ages 7-13;
- fulfills the Diagnostic Statistical Manual -5 criteria for ADHD (inattentive, hyperactive, or combined);
- speaks English;
- understands the assent form and provides informed assent;
- has parents who understand the consent form and provide informed consent;
- can commit to the full length of the protocol;
- is willing to undergo a wash-out period if already on ADHD medications;
- is willing to be randomized to treatment condition.
- Exclusion criteria include:
- physical conditions that may preclude participation;
- any conditions contraindicated for ADHD medications, or potential participants taking monoamine-oxidase inhibitors;
- pregnancy.
Where it is running
- Clinical & Affective Neuroscience Lab — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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