drugset / Trial / NCT04240756
Treating Parents with ADHD and Their Young Children Via Telehealth: a Hybrid Type I Effectiveness-Implementation Trial
Phase 3
Active not recruiting
240 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.
- 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 | 20 mg | — |
| Subject | mixed amphetamine salts | Unknown | 60 mg | — |