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

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ClinicalTrials.gov Identifier: NCT04240756
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborators:
Children's National Research Institute
University of Michigan
Seattle Children's Hospital
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Andrea M. Chronis-Tuscano, University of Maryland, College Park

Brief 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.

Condition or disease Intervention/treatment Phase
ADHD Parenting Behavioral: Behavioral Parent Training Drug: Extended release mixed amphetamine salts (MAS) Phase 3

Detailed Description:
Parental ADHD, present in 25-50% of families of children with ADHD and frequently untreated, interferes with effective parenting and predicts poor child developmental and behavioral treatment outcomes. Based on the literature and our own pilot data, the study will randomly assign parents with ADHD and their young at-risk children to one of two conditions: (1) stimulant medication for parents with ADHD followed by a child treatment strategy (CTS) beginning with behavioral parent training (BPT) with the added recommendation of child stimulant treatment if the child remains impaired or (2) a CTS without treatment for parental ADHD. The study will compare treatment effects on child ADHD-related impairment (primary outcome), child ADHD and externalizing symptoms, and time to child stimulant prescription (secondary child outcomes). The study will also examine target mechanisms including improvements in parental ADHD-related impairment and symptomatology (attention, impulsivity, emotional regulation), parenting skills, and BPT engagement, as well as treatment moderators (baseline parental ADHD severity, parental impairment, and parenting skills). Moreover, in an effort to develop a model of treatment that has potential for widespread dissemination while also reducing barriers to receiving care, the study will examine an implementation model involving parent ADHD screening in primary care followed by collaborative care delivered by co-located mental health providers via telehealth. Further, the investigators will develop an implementation plan and associated toolkit using a stakeholder participatory strategy to enhance the ability to move efficiently to adoption of this approach. In addition, the investigators will study the care delivery context, assessing procedures for and rates of screening and participation as well as staffing, workflow, provider- and patient-level acceptability, readiness, and feasibility of implementation approaches. This hybrid effectiveness-implementation project will be achieved via a collaborative R01 across 2 research sites in the US (N = 240 families), with 4-5 primary care partners at each site.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 2/2 Treating Mothers With ADHD and Their Young Children Via Telehealth: A Hybrid Type I Effectiveness-Implementation Trial
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : March 30, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Amphetamine

Arm Intervention/treatment
Experimental: 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: 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.

Drug: 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.

Active Comparator: 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: 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.




Primary Outcome Measures :
  1. Change in child ADHD-related impairment [ Time Frame: Baseline, 16 weeks, 36 weeks ]
    Assessed using the Clinical Global Impressions (CGI) - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity scale. Minimum value = 1, maximum value = 7. Higher scores indicate worse outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Child Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240756


Contacts
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Contact: Andrea M Chronis-Tuscano, Ph.D. 301-405-9640 achronis@umd.edu
Contact: Christina Danko, Ph.D. 301-405-5860 cdanko@umd.edu

Locations
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United States, Maryland
University of Maryland
College Park, Maryland, United States, 20742
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Contact: Mark Stein, Ph.D.    206-987-1161    mark.stein@seattlechildrens.org   
Sponsors and Collaborators
University of Maryland, College Park
Children's National Research Institute
University of Michigan
Seattle Children's Hospital
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Andrea Chronis-Tuscano, Ph.D. University of Maryland, College Park
Principal Investigator: Mark Stein, Ph.D. Seattle Children's Hospital
Publications:

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Responsible Party: Andrea M. Chronis-Tuscano, Professor, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT04240756    
Other Study ID Numbers: 1R01MH118320 ( U.S. NIH Grant/Contract )
1R01MH118313 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study data will be shared via the National Database for Clinical Trials related to Mental Illness (NDCT) and will be posted on clinicaltrials.gov upon completion of the grant.
Time Frame: The NFCT will be updated every 6 months and all of the data will be added to clinicaltrials.gov upon completion of the grant.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Amphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors