Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Prioreschi, Alessandra, Pearson, Rebecca, Richter, Linda, Bennin, Fiona, Theunissen, Helene, Cantrell, Sarah J, Maduna, Dumsile, Lawlor, Deborah, Norris, Shane A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
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
_version_ 1784905766267781120
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
work_keys_str_mv AT prioreschialessandra protocolfortheplaystudyarandomisedcontrolledtrialofaninterventiontoimproveinfantdevelopmentbyencouragingmaternalselfefficacyusingbehaviouralfeedback
AT pearsonrebecca protocolfortheplaystudyarandomisedcontrolledtrialofaninterventiontoimproveinfantdevelopmentbyencouragingmaternalselfefficacyusingbehaviouralfeedback
AT richterlinda protocolfortheplaystudyarandomisedcontrolledtrialofaninterventiontoimproveinfantdevelopmentbyencouragingmaternalselfefficacyusingbehaviouralfeedback
AT benninfiona protocolfortheplaystudyarandomisedcontrolledtrialofaninterventiontoimproveinfantdevelopmentbyencouragingmaternalselfefficacyusingbehaviouralfeedback
AT theunissenhelene protocolfortheplaystudyarandomisedcontrolledtrialofaninterventiontoimproveinfantdevelopmentbyencouragingmaternalselfefficacyusingbehaviouralfeedback
AT cantrellsarahj protocolfortheplaystudyarandomisedcontrolledtrialofaninterventiontoimproveinfantdevelopmentbyencouragingmaternalselfefficacyusingbehaviouralfeedback
AT madunadumsile protocolfortheplaystudyarandomisedcontrolledtrialofaninterventiontoimproveinfantdevelopmentbyencouragingmaternalselfefficacyusingbehaviouralfeedback
AT lawlordeborah protocolfortheplaystudyarandomisedcontrolledtrialofaninterventiontoimproveinfantdevelopmentbyencouragingmaternalselfefficacyusingbehaviouralfeedback
AT norrisshanea protocolfortheplaystudyarandomisedcontrolledtrialofaninterventiontoimproveinfantdevelopmentbyencouragingmaternalselfefficacyusingbehaviouralfeedback