Families Moving Forward Connect mHealth Intervention for Caregivers of Children With Fetal Alcohol Spectrum Disorders: Randomized Controlled Trial.

Background: Fetal alcohol spectrum disorders (FASD) affect 1.1% to 5% of the general population. Yet, most children with FASD and their families cannot access evidence-based interventions. Mobile health (mHealth) interventions have the potential to increase access to care on a broad scale. While numerous self-directed parenting apps exist, none have been tested for FASD. The FMF (Families Moving Forward) Connect app is a self-directed intervention derived from an empirically supported intervention for caregivers raising children with FASD. FMF Connect is the first self-directed parenting app for FASD, and also one of the first parenting apps to be systematically developed and tested. Objective: This study aimed to test the efficacy of FMF Connect for caregivers raising children with FASD on targeted primary (child behavior, caregiver attributions, parenting efficacy and satisfaction, FASD knowledge, and family needs met) and secondary (child adaptive behavior, caregiver self-care, and app satisfaction) outcomes. Methods: This study involved a 3-arm randomized controlled trial with equal allocation to groups (1) FMF Connect+coaching, (2) FMF Connect, or (3) waitlist control. Participants from the United States were recruited online through an open access website. Recruitment materials were distributed by the Collaborative Initiative on FASD, FASD listserves, and social media. In total, 129 caregivers of children (aged 3-12 y) with FASD or prenatal alcohol exposure (PAE) were enrolled. Online surveys were administered at baseline, 6 weeks, and 12 weeks. Data were analyzed with linear mixed modeling, linear regressions, and structural equation modeling using SPSS (version 29.0; IBM) and Mplus 8 (Muthén & Muthén). Results: A total of 43 participants were randomized to each group. Caregivers were predominantly White adoptive mothers. Of the total, 64% (n=83) of participants were retained through the 12-week follow-up. Groups did not differ in terms of demographic characteristics, baseline levels of functioning, or attrition. Usage patterns were similar across groups, suggesting coaching did not increase engagement. Given a few differences, app intervention groups were combined for analyses. Relative to the waitlist group, caregivers in the FMF Connect group evidenced greater improvements in FASD knowledge, child behavior attributions, family needs met, and self-care after 12 weeks (P=.01-.048). After controlling for multiple comparisons, differences in FASD knowledge, self-care, and family needs met approached significance (P=.06-.07). Groups did not differ in parenting satisfaction, child behavior problems, or adaptive functioning. More app usage is related to greater changes in parenting efficacy. Caregiver behavior attributions at 6 weeks did not mediate intervention effects. Conclusions: This study demonstrated initial efficacy of the FMF Connect app for targeted caregiver outcomes, with small to medium effect sizes. As an mHealth app, the FMF Connect intervention has potential for scalability and accessibility. This could lead to a substantial public health impact, particularly for families who face challenges accessing evidence-based resources or encounter other barriers to care.