A Phase 3 interventional study of Behavioral Parent Training and Extended release mixed amphetamine salts (MAS) in ADHD and Parenting, sponsored by University of Maryland, College Park. Completed at 1 site in United States. Open to participants aged 3 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by University of Maryland, College Park · Phase 3, Interventional, and Treatment
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.
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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This study's enrollment of 269 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
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Child Inclusion Criteria:
Child Exclusion Criteria:
Parent Inclusion Criteria:
Parent Exclusion Criteria:
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 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.
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.
Change in Child Impairment
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.
Time frame: Up to 16 weeks post-randomization
| Milestone | Parent Stimulant Medication + Child Treatment Strategy | Child Treatment Strategy | Community Stakeholders | Providers |
|---|---|---|---|---|
| Started | 120 | 120 | 0 | 0 |
| Completed | 108 | 106 | 0 | 0 |
| Not completed | 12 | 14 | 0 | 0 |
| Milestone | Parent Stimulant Medication + Child Treatment Strategy | Child Treatment Strategy | Community Stakeholders | Providers |
|---|---|---|---|---|
| Started | 120 | 120 | 0 | 0 |
| Completed | 102 | 102 | 0 | 0 |
| Not completed | 18 | 18 | 0 | 0 |
| Milestone | Parent Stimulant Medication + Child Treatment Strategy | Child Treatment Strategy | Community Stakeholders | Providers |
|---|---|---|---|---|
| Started | 120 | 120 | 13 | 16 |
| Completed | 120 | 120 | 13 | 16 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| CGI score | Parent Stimulant Medication + Child Treatment Strategy | Child Treatment Strategy |
|---|---|---|
| Change in Child Impairment | 3.78 ± 0.793 | 4.04 ± 0.898 |
Collected over Up to 36 weeks post-randomization. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Parent Stimulant Medication + Child Treatment Strategy | 0/60 (0%) | 0/60 (0%) | 44/60 (73.3%) |
| Child Treatment Strategy | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Event | Parent Stimulant Medication + Child Treatment Strategy | Child Treatment Strategy |
|---|---|---|
| InsomniaPsychiatric disorders | 25/60 | 0/60 |
| Loss of appetiteMetabolism and nutrition disorders | 25/60 | 0/60 |
| Dry MouthGastrointestinal disorders | 23/60 | 0/60 |
| HeadacheNervous system disorders | 12/60 | 0/60 |
| NauseaGastrointestinal disorders | 6/60 | 0/60 |
| JitteryNervous system disorders | 4/60 | 0/60 |
Participant Flow includes all enrolled participants. Baseline characteristics are reported only for the participant groups for whom each characteristic was collected; measures not collected for a given participant group are reported as not applicable.
| Age, Continuous(Years) | Parent Stimulant Medication + Child Treatment Strategy | Child Treatment Strategy | Community Stakeholders | Providers | Total |
|---|---|---|---|---|---|
| Mean | 5.73 ± 1.46 | 5.78 ± 1.35 | — | — | 5.76 ± 1.40 |
| Age, Continuous(Years) | Parent Stimulant Medication + Child Treatment Strategy | Child Treatment Strategy | Community Stakeholders | Providers | Total |
|---|---|---|---|---|---|
| Mean | 37.70 ± 6.08 | 39.10 ± 5.85 | — | — | 38.43 ± 5.98 |
| Age, Continuous(Years) | Parent Stimulant Medication + Child Treatment Strategy | Child Treatment Strategy | Community Stakeholders | Providers | Total |
|---|---|---|---|---|---|
| Mean | — | — | 37.54 ± 3.68 | — | 37.54 ± 3.68 |
| Age, Continuous(Years) | Parent Stimulant Medication + Child Treatment Strategy | Child Treatment Strategy | Community Stakeholders | Providers | Total |
|---|---|---|---|---|---|
| Mean | — | — | — | 43.25 ± 14.48 | 43.25 ± 14.48 |
| Sex: Female, Male(Participants) | Parent Stimulant Medication + Child Treatment Strategy | Child Treatment Strategy | Community Stakeholders | Providers | Total |
|---|---|---|---|---|---|
| Female | 16 | 25 | — | — | 41 |
| Male | 44 | 35 | — | — | 79 |
| Sex: Female, Male(Participants) | Parent Stimulant Medication + Child Treatment Strategy | Child Treatment Strategy | Community Stakeholders | Providers | Total |
|---|---|---|---|---|---|
| Female | 41 | 49 | — | — | 90 |
| Male | 19 | 11 | — | — | 30 |
| Sex: Female, Male(Participants) | Parent Stimulant Medication + Child Treatment Strategy | Child Treatment Strategy | Community Stakeholders | Providers | Total |
|---|---|---|---|---|---|
| Female | — | — | 11 | — | 11 |
| Male | — | — | 2 | — | 2 |
| Sex: Female, Male(Participants) | Parent Stimulant Medication + Child Treatment Strategy | Child Treatment Strategy | Community Stakeholders | Providers | Total |
|---|---|---|---|---|---|
| Female | — | — | — | 16 | 16 |
| Male | — | — | — | 0 | 0 |
4 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
University of Maryland, College Park