Piloting a Sequential, Multiple Assignment, Randomized Trial for Mothers with Attention-Deficit/Hyperactivity Disorder and Their At-Risk Young Children.

Objective: Parental attention-deficit/hyperactivity disorder (ADHD) is associated with suboptimal parenting and reduces the effectiveness of child ADHD treatments. We conducted a Pilot Sequential, Multiple Assignment, Randomized Trial (SMART Pilot) to evaluate the feasibility and acceptability of sequencing medication and behavioral treatments for mothers with ADHD to target outcomes, including maternal ADHD, parenting, and child ADHD symptoms/impairment in multiplex ADHD families.
Methods: Thirty-five mothers with ADHD and their 5- to 8-year-old child with ADHD symptoms were enrolled. Mothers were randomized to 8 weeks of individually titrated stimulant medication (MSM) or behavioral parent training (BPT), followed by rerandomization to 8 weeks of continued first-line treatment (with as-needed modifications) or combined treatment, leading to four treatment sequences (MSM-MSM, MSM-BPT, BPT-MSM, and BPT-BPT).
Results: Recruitment of multiplex ADHD families came primarily from child providers. Mothers were adherent to medication and had high therapy session attendance. Mothers and clinicians found both treatments to be acceptable and preferred combination treatment, especially receiving medication before BPT. Monotherapy treatment visits were viewed as more burdensome (MSM-MSM, BPT-BPT). Conclusions: Maternal stimulant medication and BPT are acceptable and feasible interventions for families in which both the mother and child have ADHD symptoms. Mothers with concerns about their children's ADHD symptoms are receptive to receiving treatment themselves as an initial strategy for improving their children's health and functioning. Fully powered SMART designs show promise in evaluating the sequencing of interventions and helping clinicians develop algorithms for treating multiplex families in real-world practice settings.

RCT Entities:   Population Interventions Outcomes