Treating Parents with ADHD and Their Young Children Via Telehealth: a Hybrid Type I Effectiveness-Implementation Trial
NCT ID: NCT04240756
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
240 participants
INTERVENTIONAL
2020-08-06
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Parent Stimulant Medication + Child Treatment Strategy
Parent stimulant medication first followed by a child treatment strategy consisting of behavioral parent training followed by a recommendation for child stimulant medication to the primary care provider if the child remains impaired.
Behavioral Parent Training
Parents will receive 10 sessions of behavioral parent training with components specifically targeted toward parents with ADHD. Treatment will be delivered via telehealth.
Extended release mixed amphetamine salts (MAS)
The MAS protocol will include a 2-4 -week open-label titration beginning at 20 mg and dose level will be increased weekly at telehealth visits with the psychopharmacologist until an optimal response or maximum dose of 60 mg.
Child Treatment Strategy
Child treatment strategy consisting of behavioral parent training followed by a recommendation for child stimulant medication to the primary care provider if the child remains impaired. In this arm, parents do not receive stimulant medication before behavioral parent training.
Behavioral Parent Training
Parents will receive 10 sessions of behavioral parent training with components specifically targeted toward parents with ADHD. Treatment will be delivered via telehealth.
Interventions
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Behavioral Parent Training
Parents will receive 10 sessions of behavioral parent training with components specifically targeted toward parents with ADHD. Treatment will be delivered via telehealth.
Extended release mixed amphetamine salts (MAS)
The MAS protocol will include a 2-4 -week open-label titration beginning at 20 mg and dose level will be increased weekly at telehealth visits with the psychopharmacologist until an optimal response or maximum dose of 60 mg.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
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
3 Years
65 Years
ALL
No
Sponsors
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Children's National Research Institute
OTHER
University of Michigan
OTHER
Seattle Children's Hospital
OTHER
National Institute of Mental Health (NIMH)
NIH
University of Maryland, College Park
OTHER
Responsible Party
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Andrea Chronis-Tuscano
Professor
Principal Investigators
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Andrea Chronis-Tuscano, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, College Park
Locations
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University of Maryland
College Park, Maryland, United States
Countries
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References
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