Parent-mediated interventions versus usual care in children with autism spectrum disorders. A systematic review with meta-analysis and Trial Sequential Analysis.

Abstract Background Autism spectrum disorder encompasses diverse patterns of social-communication and repetitive, restricted behaviours, and is associated with a higher risk of comorbid medical and psychiatric disorders. Various interventions have been developed to reduce the negative consequences of autism spectrum disorder and improve levels of functioning. Within different frameworks of interventions, there is increasing interest in parent-mediated interventions. This systematic review with meta-analysis aims to synthesise the current evidence of the effects, both positive and adverse, of parent-mediated interventions on younger children with autism spectrum disorder and their parents. Methods Electronic searches will be conducted in Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica database (EMBASE), Latin American and Caribbean Health Sciences Literature (LILACS), American Psychological Association PsycInfo (PsycInfo), Science Citation Index Expanded (SCI-EXPANDED). Randomised clinical trials of parent-mediated interventions for children with autism and a control-group of usual care, waiting list or no treatment will be included. Two reviewers will independently screen, select and collect data. The methodological quality of the included studies will be evaluated using Cochrane methodology. The primary outcome will be autism symptom severity as measured by the Autism Diagnostic Observation Schedule (ADOS). Secondary outcomes will be adaptive functioning, adverse effects, child language, child socio-communicative symptoms, child´s quality of life and parental quality of life. The meta-analysis will be performed with Trial Sequential Analysis. Discussion This is the study protocol for a systematic review and meta-analysis of parent-mediated interventions versus usual care for children with autism spectrum disorder. The results of the review will inform clinicians and parents about the current evidence of the effects, both positive and adverse, of parent-mediated interventions on younger children with autism spectrum disorder and their parents, through improved methodology and the inclusion of new studies. Protocol registration: PROSPERO 385188