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

NCT04240756 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 1R01MH1183201R01MH118313
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD; Parenting

Outcome Measures

Primary Outcomes (1)

• Change in child ADHD-related impairment

  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.

  Baseline, 16 weeks, 36 weeks

Study Arms (2)

Parent Stimulant Medication + Child Treatment Strategy

EXPERIMENTAL

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; Drug: Extended release mixed amphetamine salts (MAS)

Child Treatment Strategy

ACTIVE COMPARATOR

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

Interventions

Behavioral Parent Training BEHAVIORAL

Parents will receive 10 sessions of behavioral parent training with components specifically targeted toward parents with ADHD. Treatment will be delivered via telehealth.

Child Treatment Strategy; Parent Stimulant Medication + Child Treatment Strategy

Extended release mixed amphetamine salts (MAS) DRUG

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.

Parent Stimulant Medication + Child Treatment Strategy

Eligibility Criteria

• Age: 3 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, College Park: lead
• Children's National Research Institute: collaborator
• University of Michigan: collaborator
• Seattle Children's Hospital: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Maryland

College Park, Maryland, 20742, United States

Location

Related Publications (7)

• Chronis-Tuscano A, Seymour KE, Stein MA, Jones HA, Jiles CD, Rooney ME, Conlon CJ, Efron LA, Wagner SA, Pian J, Robb AS. Efficacy of osmotic-release oral system (OROS) methylphenidate for mothers with attention-deficit/hyperactivity disorder (ADHD): preliminary report of effects on ADHD symptoms and parenting. J Clin Psychiatry. 2008 Dec;69(12):1938-47. doi: 10.4088/jcp.v69n1213. Epub 2008 Dec 2.

  PMID: 19192455 BACKGROUND

• Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

  PMID: 22310560 BACKGROUND

• Schoenfelder EN, Chronis-Tuscano A, Strickland J, Almirall D, Stein MA. Piloting a Sequential, Multiple Assignment, Randomized Trial for Mothers with Attention-Deficit/Hyperactivity Disorder and Their At-Risk Young Children. J Child Adolesc Psychopharmacol. 2019 May;29(4):256-267. doi: 10.1089/cap.2018.0136. Epub 2019 Apr 13.

  PMID: 30950637 BACKGROUND

• Chronis-Tuscano A, Rooney M, Seymour KE, Lavin HJ, Pian J, Robb A, Efron L, Conlon C, Stein MA. Effects of maternal stimulant medication on observed parenting in mother-child dyads with attention-deficit/hyperactivity disorder. J Clin Child Adolesc Psychol. 2010;39(4):581-7. doi: 10.1080/15374416.2010.486326.

  PMID: 20589568 BACKGROUND

• Chronis-Tuscano A, O'Brien KA, Johnston C, Jones HA, Clarke TL, Raggi VL, Rooney ME, Diaz Y, Pian J, Seymour KE. The relation between maternal ADHD symptoms & improvement in child behavior following brief behavioral parent training is mediated by change in negative parenting. J Abnorm Child Psychol. 2011 Oct;39(7):1047-57. doi: 10.1007/s10802-011-9518-2.

  PMID: 21537894 BACKGROUND

• Chronis-Tuscano A, Wang CH, Woods KE, Strickland J, Stein MA. Parent ADHD and Evidence-Based Treatment for Their Children: Review and Directions for Future Research. J Abnorm Child Psychol. 2017 Apr;45(3):501-517. doi: 10.1007/s10802-016-0238-5.

  PMID: 28025755 BACKGROUND

• Lui JHL, Danko CM, Triece T, Bennett IM, Marschall D, Lorenzo NE, Stein MA, Chronis-Tuscano A. Screening for parent and child ADHD in urban pediatric primary care: pilot implementation and stakeholder perspectives. BMC Pediatr. 2023 Jul 13;23(1):354. doi: 10.1186/s12887-023-04082-2.

  PMID: 37442955 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Andrea Chronis-Tuscano, Ph.D.

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: August 6, 2020
• Primary Completion: May 30, 2025
• Study Completion: July 31, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)