ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy): An RCT for infants at risk of ASD

Abstract

Objective: Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental condition which impacts on behaviour, cognition, communication, social interaction and family mental health. Current research is exploring earlier identification and intervention, with parent-child interactions identified as a means of improving infant outcomes. This paper reports the protocol of a randomised controlled trial (RCT) of an innovative very early intervention ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy) for families of infants at risk of ASD. Design: Protocol of a RCT. Method: We aim to recruit 66 mothers of infants at risk of ASD (i.e., infants with a sibling or parent diagnosed with ASD) to this study. Families will be randomly assigned to care as usual or ENACT. ENACT is a very early intervention, leveraging parent-child interactions to improve early social reciprocity, while supporting parental mental health and the parent-child relationship through Acceptance and Commitment Therapy (ACT). Intervention content is delivered online, supported by consultations with a qualified clinician. Parents will perform the social reciprocity intervention within their own home. Assessments at four time points (baseline; 3 months, 6 months and 12 months corrected age) will assess parent-infant interaction, parental mental health, infant development and early ASD markers. Analysis will be by intention to treat using general linear models for randomised controlled trials. Results: This protocol has been approved by the Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/19/QCHQ/50131) and The University of Queensland (2019000558). If efficacy is demonstrated, the intervention has the potential for wide and accessible dissemination. This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618002046280p). Conclusion: To our knowledge this is the first RCT to test a very early intervention for infants at risk of ASD implemented within the first 6 months of life. The ENACT intervention combines parent-mediated very early intervention for infants at risk of ASD and mental health support for their parents. The assessments include neurodevelopmental and neurophysiological assessments, as well as observations of parent-child interaction. The intervention includes a significant online component, which could, if effective, be widely disseminated at little cost.L6316059592020-05-04 <br />