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Protocol for the PLAY Study: a randomised controlled trial of an intervention to improve infant development by encouraging maternal self-efficacy using behavioural feedback
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...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10008478/ https://www.ncbi.nlm.nih.gov/pubmed/36882258 http://dx.doi.org/10.1136/bmjopen-2022-064976 |
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author | Prioreschi, Alessandra Pearson, Rebecca Richter, Linda Bennin, Fiona Theunissen, Helene Cantrell, Sarah J Maduna, Dumsile Lawlor, Deborah Norris, Shane A |
author_facet | Prioreschi, Alessandra Pearson, Rebecca Richter, Linda Bennin, Fiona Theunissen, Helene Cantrell, Sarah J Maduna, Dumsile Lawlor, Deborah Norris, Shane A |
author_sort | Prioreschi, Alessandra |
collection | PubMed |
description | 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). |
format | Online Article Text |
id | pubmed-10008478 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-100084782023-03-13 Protocol for the PLAY Study: a randomised controlled trial of an intervention to improve infant development by encouraging maternal self-efficacy using behavioural feedback Prioreschi, Alessandra Pearson, Rebecca Richter, Linda Bennin, Fiona Theunissen, Helene Cantrell, Sarah J Maduna, Dumsile Lawlor, Deborah Norris, Shane A BMJ Open Public Health 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). BMJ Publishing Group 2023-03-07 /pmc/articles/PMC10008478/ /pubmed/36882258 http://dx.doi.org/10.1136/bmjopen-2022-064976 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Public Health Prioreschi, Alessandra Pearson, Rebecca Richter, Linda Bennin, Fiona Theunissen, Helene Cantrell, Sarah J Maduna, Dumsile Lawlor, Deborah Norris, Shane A Protocol for the PLAY Study: a randomised controlled trial of an intervention to improve infant development by encouraging maternal self-efficacy using behavioural feedback |
title | Protocol for the PLAY Study: a randomised controlled trial of an intervention to improve infant development by encouraging maternal self-efficacy using behavioural feedback |
title_full | Protocol for the PLAY Study: a randomised controlled trial of an intervention to improve infant development by encouraging maternal self-efficacy using behavioural feedback |
title_fullStr | Protocol for the PLAY Study: a randomised controlled trial of an intervention to improve infant development by encouraging maternal self-efficacy using behavioural feedback |
title_full_unstemmed | Protocol for the PLAY Study: a randomised controlled trial of an intervention to improve infant development by encouraging maternal self-efficacy using behavioural feedback |
title_short | Protocol for the PLAY Study: a randomised controlled trial of an intervention to improve infant development by encouraging maternal self-efficacy using behavioural feedback |
title_sort | protocol for the play study: a randomised controlled trial of an intervention to improve infant development by encouraging maternal self-efficacy using behavioural feedback |
topic | Public Health |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10008478/ https://www.ncbi.nlm.nih.gov/pubmed/36882258 http://dx.doi.org/10.1136/bmjopen-2022-064976 |
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