ADHD, Parenting
Conditions
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.
Interventions
BEHAVIORALBehavioral 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.
DRUGExtended 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.
Sponsors
University of Maryland, College Park
Children's National Research Institute
University of Michigan
Seattle Children's Hospital
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Child Impairment | Up to 16 weeks post-randomization | Assessed using the Clinical Global Impressions (CGI) - Severity scale. Minimum value = 1, maximum value = 7. Higher scores indicate worse outcomes. The Child CGI outcome was collected for enrolled parent-child dyads. Community stakeholders and providers were not assessed for this outcome. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrea Chronis-Tuscano, Ph.D.
University of Maryland, College Park
Participant flow
Pre-assignment details
Parents were randomized to treatment conditions. Children were enrolled as part of parent-child dyads. Stakeholders and providers participated in baseline assessments and were not assigned to treatment arms.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 43.25 Years STANDARD_DEVIATION 14.48 |
| Child Global CGI-S | 4.77 Points STANDARD_DEVIATION 0.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Parent CGI-S ADHD | 4.65 points STANDARD_DEVIATION 0.65 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 70 Participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 44 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
None listed