drugset / Trial / NCT04240756
Treating Parents With ADHD and Their Young Children Via Telehealth: A Hybrid Type I Effectiveness-Implementation Trial
Phase 3
Completed
269 enrolled
University of Maryland, College Park
Children's National Research Institute · collabNational Institute of Mental Health (NIMH) · collabSeattle Children's Hospital · collabUniversity of Michigan · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2020-08-06
- Primary completion
- 2025-05-30
- Completion
- 2025-07-31
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Chronis-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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mixed amphetamine salts | Unknown | — | — |