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RCT·pediatrics, public health, clinical trial, psychiatry, obstetrics and gynecology·PMC10008478

Protocol for the PLAY Study: a randomised controlled trial of an intervention to improve infant development by encouraging maternal self-efficacy using behavioural feedback

BMJ Open · 9 authors, 4 centres

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TL;DR

This is a protocol for a phase 1 randomised controlled trial to test an intervention designed to improve infant development by enhancing maternal self-efficacy through behavioural feedback and support. The trial plans to recruit 210 mother-infant pairs in South Africa and will compare standard care to the intervention, with primary outcomes assessed at 12 months.

Full summary

523 CHARS

This paper is a protocol for a phase 1 randomised controlled trial (RCT). The study will recruit 210 mother-infant pairs at delivery in Soweto, South Africa, and randomise them 1:1 to an intervention or standard care control group. Data collection will occur at 0, 6, and 12 months. The protocol outlines a complex intervention with a clear rationale but notes potential limitations in participant access to technology and the generalizability of findings to the specific socioeconomically disadvantaged population studied.

STUDY TYPE

RCT

SPECIALTY

pediatrics

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10008478

Protocol for the PLAY Study: a randomised controlled trial of an intervention to improve infant development by encouraging maternal self-efficacy using behavioural feedback

BMJ Open

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ABSTRACT

Abstract Introduction The early infant caregiving environment is crucial in the formation of parent–child relationships, neurobehavioural development and thus child outcomes. This protocol describes the Play Love And You (PLAY) Study, a phase 1 trial of an intervention designed to promote infant development through encouraging maternal self-efficacy using behavioural feedback, and supportive interventions. Methods and analysis 210 mother–infant pairs will be recruited at delivery from community clinics in Soweto, South Africa, and individually randomised (1:1) into two groups. The trial will consist of a standard of care arm and an intervention arm. The intervention will start at birth and end at 12 months, and outcome assessments will be made when the infants are 0, 6 and 12 months of age. The intervention will be delivered by community health helpers using an app with resource material, telephone calls, in person visits and behavioural feedback with individualised support. Every 4 months, mothers in the intervention group will receive rapid feedback via the app and in person on their infant’s movement behaviours and on their interaction styles with their infant. At recruitment, and again at 4 months, mothers will be screened for mental health risk and women who score in the high-risk category will receive an individual counselling session from a licensed psychologist, followed by referral and continued support as necessary. The primary outcome is efficacy of the intervention in improving maternal self-efficacy, and the secondary outcomes are infant development at 12 months, and feasibility and acceptability of each component of the intervention. Ethics and dissemination The PLAY Study has received ethical approval from the Human Research Ethics Committee of the University of the Witwatersrand (M220217). Participants will be provided with an information sheet and required to provide written consent prior to being enrolled. Study results will be shared via publication in peer-reviewed journals, conference presentation and media engagement. Trial registration number This trial was registered with the Pan African Clinical Trials Registry ( https://pactr.samrc.ac.za ) on 10 February 2022 (identifier: PACTR202202747620052). Keywords: Community child health, PUBLIC HEALTH, EPIDEMIOLOGY

CITATION EXPORT

Alessandra Prioreschi, Rebecca Pearson, Linda Richter et al.. Protocol for the PLAY Study: a randomised controlled trial of an intervention to improve infant development by encouraging maternal self-efficacy using behavioural feedback. BMJ Open. (2023). https://doi.org/10.1136/bmjopen-2022-064976

AUTHORS

9 · 4 CENTRES

Alessandra Prioreschi, Rebecca Pearson, Linda Richter, Fiona Bennin, Helene Theunissen, Sarah J Cantrell, Dumsile Maduna, Deborah Lawlor, Shane A Norris

1SAMRC/Wits Developmental Pathways for Health Research Unit, University of the Witwatersrand, Johannesburg, South Africa
2Centre for Academic Mental Health, Addiction and Suicide Research, School of Social & Community Medicine, University of Bristol, Bristol, UK
3DSI-NRF Centre of Excellence in Human Development, University of the Witwatersrand, Johannesburg, South Africa
4Department of Social Medicine, MRC Integrative Epidemiology Unit, University of Bristol, Bristol, UK