drugset / Trial / NCT04737512

Mindfulness-Based ADHD Treatment for Children: a Feasibility Study

NCT04737512

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2021-02-01
Primary completion
2024-10-29
Completion
2024-10-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Clonidine Other / unclassified
Subject Guanfacine Small molecule
Subject Lisdexamfetamine Dimesylate Small molecule
Subject Methylphenidate Small molecule