Clinical trial NCT04240756: Treating Parents with ADHD and Their Young Children Via Telehealth: a Hybrid Type I Effectiveness-Implementation Trial
Official title: 2/2 Treating Mothers with ADHD and Their Young Children Via Telehealth: a Hybrid Type I Effectiveness-Implementation Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: ADHD
Parenting
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: Children's National Research Institute
name: University of Michigan
name: Seattle Children's Hospital
name: National Institute of Mental Health (NIMH)
First posted: 2020-01-27
Enrollment: 240
Sex: ALL
Minimum age (years): 3
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in child ADHD-related impairment
timeFrame: Baseline, 16 weeks, 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: College Park
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Andrea Chronis-Tuscano, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.