Introduction The aim of this paper is to provide a protocol for a systematic review assessing the effectiveness of evidence from randomised controlled trials comparing fetal alcohol spectrum disorders pharmacological and non-pharmacological interventions with placebo/dummy interventions or usual standards of care in children and adolescents (<18 years old).
Methods and analysis The following electronic databases will be searched: Medline (Ovid), Cumulative Index of Nursing and Allied Health Plus with Full text (EBSCO), Cochrane Central Register of Controlled Trials (Cochrane Library—Wiley), PsycINFO (ProQuest) and Proquest DissertationsandTheses will be searched from inception to March 2017 for relevant citations of published trials using individualised search strategies prepared for database. We will also search the reference lists of relevant articles and conference proceedings. Two reviewers will independently assess each study against predetermined inclusion/exclusion criteria and extract data including population characteristics, types and duration of interventions and outcomes from included trials. Internal validity will be assessed using the Cochrane Risk of Bias Tool. Primary outcome measures will be improvements in symptoms, including: hyperactivity, impulsivity and attention as measured by standard rating scales. Secondary outcome measures will include improvements in physical and mental health domains, as well as cognitive, behavioural, social and educational skills as measured by rating scales, standardised psychometric tests of IQ and memory, grade repetition, literacy tests and diagnosis of mental health disorder.
Ethics and dissemination Ethical approval will not be obtained since it is not required for systematic reviews as there are no concerns regarding patient privacy. The results of this review will be disseminated through publication in a peer-review journal and presented at relevant conferences.
PROSPERO registration number CRD42013005996.
- fetal alcohol spectrum disorder
- childhood intervention
- study protocol
- systematic review
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Contributors This study was conceived by DS, RZ and AM-S. The manuscript of this protocol was drafted by DS and revised by CM, CJN, MB, AH-D, AC, RZ and AM-S. DS and CN designed the search strategies and CJN will perform the search. DS and CM will independently screen trials for inclusion, extract data and assess the risk of bias of included trials. DS and AM-S will analyse and interpret the data. AM-S will arbitrate any disagreements during the screening, extraction or critical appraisal phases. MB, AH-D and AC have provided content expertise, and RZ and AM-S have provided methodological expertise that have guided this paper. All authors approved the final version of this protocol.
Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
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