Treating Parents With ADHD and Their Young Children Via Telehealth: A Hybrid Type I Effectiveness-Implementation Trial

• Status: Recruiting
• Trial end date: 2024-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the effectiveness of combined parental stimulant medication and behavioral parent training (BPT) versus BPT alone on child ADHD-related impairment (primary outcome), child ADHD and externalizing symptoms, time to child stimulant prescription (secondary child outcomes) and parental ADHD impairment, parental ADHD symptoms, parenting, and BPT engagement (parental outcomes/target mechanisms). This study will also assess the care delivery context and develop an implementation approach for treatment of families with a parent with ADHD and a child with elevated ADHD symptoms via telehealth in primary care sites providing pediatric care.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland, College Park
• Collaborators: Children's National Research Institute; Children's Research Institute; National Institute of Mental Health (NIMH); Seattle Children's Hospital; University of Michigan
• Treatments: Amphetamine

Criteria

Child Inclusion Criteria:

• Be at least 3 years old and no more than 8 years old

• ADHD medication naive or have not had an adequate trial of stimulant medications

• Have ≥5 inactivity or ≥5 hyperactivity symptoms rated as 1 or 2 on the Vanderbilt

• Have a CGI-S-ADHD rating ≥4 and <7

Child Exclusion Criteria:

• Severe ADHD (CGI-S-ADHD score of greater than 6)

Parent Inclusion Criteria:

• Be at least 21 years old and English-speaking

• Meet full DSM-5 criteria for ADHD (any subtype)

• Have findings on physical examination, laboratory studies, vital signs, and electrocardiogram judged to be normal for age with no contraindications for stimulant medication

• Have pulse and blood pressure (BP) within 95% of age and gender mean

• Women of childbearing potential agree to use a medically accepted contraception method consistently

• Parents with common comorbid conditions will be included provided that: (a) they do not report active suicidal ideation with intent (i.e. Beck Depression Inventory (BDI)-II score of 2 or 3 to Q9 which assesses suicidal thoughts); and (b) if receiving an antidepressant medication, their medication is well-tolerated, has not changed within 30 days, and the prescribing physician approves of their participation in the study

• Must have regular access to a computer or phone that can be used to deliver the behavioral parent training

Parent Exclusion Criteria:

• History of allergic or other severe negative reactions to study medications

• Substance abuse in the past 3 months, or a positive baseline urinary toxic screen that is not explained by a time-limited medical circumstance

• Current bipolar disorder, schizophrenia, psychoses, or other primary psychiatric disorder requiring other immediate treatment

• History of chronic/acute medical disorder for which stimulant therapy would be contraindicated (e.g., glaucoma, hypertension)

• Stimulant medication for ADHD in the past 30 days

• Is pregnant