School-based intervention to address self-regulation and executive functioning in children attending primary schools in remote Australian Aboriginal communities.

Executive functioning and self-regulation influence a range of outcomes across the life course including physical and mental health, educational success, and employment. Children prenatally exposed to alcohol or early life trauma (ELT) are at higher risk of impairment of these skills and may require intervention to address self-regulation deficits. Researchers partnered with the local Aboriginal health organization and schools to develop and pilot a manualized version of the Alert Program® in the Fitzroy Valley, north Western Australia, a region with documented high rates of fetal alcohol spectrum disorder and ELT. This self-controlled cluster randomized trial evaluated the effect of an 8-week Alert Program® intervention on children's executive functioning and self-regulation skills. Following parent or caregiver consent (referred to hereafter as parent), 271 students were enrolled in the study. This reflects a 75% participation rate and indicates the strong community support that exists for the study. Teachers from 26 primary school classrooms across eight Fitzroy Valley schools received training to deliver eight, one-hour Alert Program® lessons over eight-weeks to students. Student outcomes were measured by parent and teacher ratings of children's behavioral, emotional, and cognitive regulation. The mean number of lessons attended by children was 4.2. Although no significant improvements to children's executive functioning skills or behavior were detected via the teacher-rated measures as hypothesized, statistically significant improvements were noted on parent-rated measures of executive functioning and behavior. The effectiveness of future self-regulation programs may be enhanced through multimodal delivery through home, school and community based settings to maximize children's exposure to the intervention. Despite mixed findings of effect, this study was an important first step in adapting and evaluating the Alert Program® for use in remote Australian Aboriginal community schools, where access to self-regulation interventions is limited.

Study protocol for a self-controlled cluster randomised trial of the Alert Program to improve self-regulation and executive function in Australian Aboriginal children with fetal alcohol spectrum disorder.

INTRODUCTION: While research highlights the benefits of early diagnosis and intervention for children with fetal alcohol spectrum disorders (FASD), there are limited data documenting effective interventions for Australian children living in remote communities. METHODS AND ANALYSIS: This self-controlled cluster randomised trial is evaluating the effectiveness of an 8-week Alert Program school curriculum for improving self-regulation and executive function in children living in remote Australian Aboriginal communities. Children in grades 1-6 attending any of the eight participating schools across the Fitzroy Valley in remote North-West Australia (N ≈ 363) were invited to participate. Each school was assigned to one of four clusters with clusters randomly assigned to receive the intervention at one of four time points. Clusters two, three and four had extended control conditions where students received regular schooling before later receiving the intervention. Trained classroom teachers delivered the Alert Program to students in discrete, weekly, 1-hour lessons. Student outcomes were assessed at three time points. For the intervention condition, data collection occurred 2 weeks immediately before and after the intervention, with a follow-up 8 weeks later. For control conditions in clusters two to four, the control data collection matched that of the data collection for the intervention condition in the preceding cluster. The primary outcome is change in self-regulation. FASD diagnoses will be determined via medical record review after the completion of data collection. The results will be analysed using generalised linear mixed modelling and reported in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of Western Australia (WA) (RA/4/1/7234), WA Aboriginal Health Ethics Committee (601) and WA Country Health Service (2015:04). The Kimberley Aboriginal Health Planning Forum Research Sub-Committee and WA Department of Education also provided approval. The results will be disseminated through peer-reviewed journals, conference presentations, the media and at forums. TRIAL REGISTRATION NUMBER: ACTRN12615000733572; Pre-results.

The development of a culturally appropriate school based intervention for Australian Aboriginal children living in remote communities: A formative evaluation of the Alert Program® intervention.

BACKGROUND/AIM: Although previous research has demonstrated the benefits of targeting self-regulation in non-Aboriginal children, it is unclear whether such programs would be effective for Aboriginal children attending school in remote communities. Some of these children have been diagnosed with a fetal alcohol spectrum disorder (FASD) impairing their ability to self-regulate. The aim of this article is to describe a three phase formative process to develop and pilot a curriculum version of the Alert Program® , a promising intervention for improving self-regulation that could be used in remote community schools. This modified version of the program will be subsequently tested in a cluster randomised controlled trial. METHODS: A mixed methods approach was used. RESULTS: Modifications to the Alert Program® , its delivery and evaluation were made after community and stakeholder consultation facilitated by a senior Aboriginal community researcher. Changes to lesson plans and program resources were made to reflect the remote community context, classroom environment and the challenging behaviours of children. Standardised study outcome measures were modified by removing several questions that had little relevance to the lives of children in remote communities. Program training for school staff was reduced in length to reduce staff burden. CONCLUSIONS: This study identified aspects of the Alert Program® training, delivery and measures for evaluation that need modification before their use in assessing the efficacy of the Alert Program® in remote Aboriginal community primary schools.