ADHDPhase 3TPACNCT04240756
Treating Parents With ADHD and Their Young Children Via Telehealth: A Hybrid Type I Effectiveness-Implementation Trial
A Phase 3 study testing Behavioral Parent Training and Extended release mixed amphetamine salts (MAS) in people with ADHD and Parenting, run by University of Maryland, College Park at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 65 years
- What is being tested?
- Behavioral Parent Training and Extended release mixed amphetamine salts (MAS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2020to 31 Jul 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland
College Park, Maryland, 20742
About this study
Official title: 2/2 Treating Mothers With ADHD and Their Young Children Via Telehealth: A Hybrid Type I Effectiveness-Implementation Trial
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.
Read the 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.
- Being tested
- Behavioral Parent Training, Extended release mixed amphetamine salts (MAS)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Parent TrainingBehavioural
Parents will receive 10 sessions of behavioral parent training with components specifically targeted toward parents with ADHD. Treatment will be delivered via telehealth.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Behavioral Parent Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 16 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start6 Aug 2020
- Primary completion30 May 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- Children's National Research Institute, University of Michigan, Seattle Children's Hospital, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Andrea Chronis-Tuscano, University of Maryland, College Park
- Investigators
- Andrea Chronis-Tuscano, Ph.D., Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240756
- Sponsor's protocol ID
- 1R01MH118320
- Other IDs
- 1R01MH118313
- Acronym
- TPAC
- Status last verified
- Aug 2026
- First submitted
- 21 Jan 2020
- Last updated
- 16 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 19192455Curran 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.
PubMed 22310560Schoenfelder 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.
PubMed 30950637Chronis-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.
PubMed 20589568Chronis-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.
PubMed 21537894Chronis-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.
PubMed 28025755Chronis-Tuscano A, Bounoua N, Danko CM, Almirall D, Lui JHL, Marschall D, Taubin D, Bui HNT, Marsh NP, Efron L, Dorfman J, Lorenzo NE, Dvorsky M, Bennett IM, Atabaki SM, Robb AS. Treating parents with ADHD and their children (TPAC): a hybrid effectiveness-implementation, randomized controlled trial. J Child Psychol Psychiatry. 2026 Aug 18. doi: 10.1111/jcpp.70222. Online ahead of print.
PubMed 42611696Lui 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.
PubMed 37442955