JMIR Publications

ABSTRACT

Background:

Fetal alcohol spectrum disorders (FASD) affect 1.1 to 5 percent of the general population. Yet most children with FASD and their families cannot access evidence-based interventions in their communities due to limited provider training in FASD, waitlists, provider shortages, low uptake of interventions, and pervasive stigma. Mobile health (mHealth) interventions offer the potential to increase access to care on a broad scale. While numerous self-directed parenting apps exist in app stores, none have been developed for FASD or empirically tested. The Families Moving Forward (FMF) Connect app is a self-directed intervention derived from an empirically-supported, specialist-led intervention for caregivers raising children with FASD. FMF Connect is not only the first self-directed parenting app for FASD, but also one of the first parenting apps to be systematically developed and tested.

Objective:

To test the efficacy of the FMF Connect app for caregivers raising children with FASD.

Methods:

This study involved a 3-arm randomized controlled trial with equal allocation to groups: 1) FMF Connect + text-based coaching, 2) FMF Connect, or 3) waitlist control group. Participants were recruited online through an open access website. Recruitment materials were distributed by investigators in the Collaborative Initiative on FASD (CIFASD), FASD listservs, and social media. 129 caregivers of children (ages 3-12) with FASD or prenatal alcohol exposure (PAE) were enrolled. Online surveys were administered at baseline, 6-weeks, and 12-weeks. Data were analyzed with repeated measures ANOVAs, linear regressions, and structural equation modeling utilizing SPSS version 29.0, R version 2024.04.1, and Mplus 8.

Results:

43 participants were randomized to each group. 64 percent of participants were retained through the 12-week follow-up. Groups did not generally differ in terms of demographic characteristics, baseline levels of functioning, or patterns of attrition. Usage patterns were similar across intervention groups, suggesting coaching did not increase app engagement. Given few differences, app intervention groups were combined for outcome analyses. Relative to the waitlist comparison group, caregivers who received the FMF Connect app evidenced greater improvements in child behavior attributions, parenting satisfaction, and family needs met after 12 weeks (p = .011 - .044). After controlling for multiple comparisons, differences in family needs met approached significance (p = 0.06). Groups did not differ in parenting efficacy, self-care, or child behavior problems or adaptive functioning. Caregiver behavior attributions at 6-weeks did not significantly mediate intervention effects.

Conclusions:

This study demonstrated initial efficacy of the FMF Connect app for targeted caregiver outcomes, with effect sizes in the small to medium range. As a mHealth app, the FMF Connect intervention has potential for scalability and accessibility. This could lead to substantial public health impact, particularly for families who face challenges accessing evidence-based resources or encounter other barriers to care. Clinical Trial: ClinicalTrials.gov NCT05028517