MedTrace Logo

Mindfulness-Based ADHD Treatment for Children: a Feasibility Study

NCT04737512 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-11-25

No results posted yet for this study

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.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

BEHAVIORAL

Mindfulness-Based ADHD Treatment for Children

MBAT-C is derived from Mindfulness-Based Stress Reduction (MBSR), a well-known and extensively-studied mindfulness intervention. Unlike all other mindfulness-based interventions, however, MBAT-C is tailored to the needs, abilities, and vulnerabilities of children with ADHD through the use of age-appropriate class length, homework assignments, contemplative practices, and discussion topics.

BIOLOGICAL

Goal-Standard Medication (Treatment as Usual)

Participants will receive gold-standard, non-experimental medication. This treatment arm relies on a step-by-step approach that is designed to mimic pharmacologic treatment-as-usual in the community. The treatment algorithm is as follows: 1. All participants will start with Concerta; Ritalin may be started if the effect of Concerta wears off mid-day; 2. If Concerta +/- Ritalin is ineffective or not tolerated, participants will progress to Vyvanse; Adderall may be started if the effect of Vyvanse wears off mid-day; 3. If Vyvanse +/- Adderall is also ineffective or not tolerated, participants will progress to Kapvay; 4. If Kapvay is ineffective or not tolerated, participants will progress to Intuniv. 5. Alternative combinations of the above medications will be considered if the above combinations are ineffective or otherwise not tolerated.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Hedy Kober, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04737512 on ClinicalTrials.gov