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Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol
INTRODUCTION: Early intervention programmes (EIPs) for infants with neurodevelopmental impairment have been poorly studied especially in low-income settings. We aim to evaluate the feasibility and acceptability of a group participatory EIP, the ‘ABAaNA EIP’, for young children with neurodevelopmenta...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6797334/ https://www.ncbi.nlm.nih.gov/pubmed/31601606 http://dx.doi.org/10.1136/bmjopen-2019-032705 |
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author | Nampijja, Margaret Webb, Emily Nanyunja, Carol Sadoo, Samantha Nalugya, Ruth Nyonyintono, James Muhumuza, Anita Ssekidde, Moses Katumba, Kenneth Magnusson, Brooke Kabugo, Daniel Cowan, Frances M Martinez-Biarge, Miriam Zuurmond, Maria Morgan, Cathy Lester, Deborah Seeley, Janet Tann, Cally J |
author_facet | Nampijja, Margaret Webb, Emily Nanyunja, Carol Sadoo, Samantha Nalugya, Ruth Nyonyintono, James Muhumuza, Anita Ssekidde, Moses Katumba, Kenneth Magnusson, Brooke Kabugo, Daniel Cowan, Frances M Martinez-Biarge, Miriam Zuurmond, Maria Morgan, Cathy Lester, Deborah Seeley, Janet Tann, Cally J |
author_sort | Nampijja, Margaret |
collection | PubMed |
description | INTRODUCTION: Early intervention programmes (EIPs) for infants with neurodevelopmental impairment have been poorly studied especially in low-income settings. We aim to evaluate the feasibility and acceptability of a group participatory EIP, the ‘ABAaNA EIP’, for young children with neurodevelopmental impairment in Uganda. METHODS AND ANALYSIS: We will conduct a pilot feasibility, single-blinded, randomised controlled trial comparing the EIP with standard care across two study sites (one urban, one rural) in central Uganda. Eligible infants (n=126, age 6–11 completed months) with neurodevelopmental impairment (defined as a developmental quotient <70 on Griffiths Scales of Mental Development, and, or Hammersmith Infant Neurological Examination score <60) will be recruited and randomised to the intervention or standard care arm. Intervention arm families will receive the 10-modular, peer-facilitated, participatory, community-based programme over 6 months. Recruited families will be followed up at 6 and 12 months after recruitment, and assessors will be blinded to the trial allocation. The primary hypothesis is that the ABAaNA EIP is feasible and acceptable when compared with standard care. Primary outcomes of interest are feasibility (number recruited and randomised at baseline) and acceptability (protocol violation of arm allocation and number of sessions attended) and family and child quality of life. Guided by the study aim, the qualitative data analysis will use a data-led thematic framework approach. The findings will inform scalability and sustainability of the programme. ETHICS AND DISSEMINATION: The trial protocol has been approved by the relevant Ugandan and UK ethics committees. Recruited families will give written informed consent and we will follow international codes for ethics and good clinical practice. Dissemination will be through peer-reviewed publications, conference presentations and public engagement. TRIAL REGISTRATION NUMBER: ISRCTN44380971; protocol version 3.0, 19th February 2018. |
format | Online Article Text |
id | pubmed-6797334 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-67973342019-10-31 Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol Nampijja, Margaret Webb, Emily Nanyunja, Carol Sadoo, Samantha Nalugya, Ruth Nyonyintono, James Muhumuza, Anita Ssekidde, Moses Katumba, Kenneth Magnusson, Brooke Kabugo, Daniel Cowan, Frances M Martinez-Biarge, Miriam Zuurmond, Maria Morgan, Cathy Lester, Deborah Seeley, Janet Tann, Cally J BMJ Open Paediatrics INTRODUCTION: Early intervention programmes (EIPs) for infants with neurodevelopmental impairment have been poorly studied especially in low-income settings. We aim to evaluate the feasibility and acceptability of a group participatory EIP, the ‘ABAaNA EIP’, for young children with neurodevelopmental impairment in Uganda. METHODS AND ANALYSIS: We will conduct a pilot feasibility, single-blinded, randomised controlled trial comparing the EIP with standard care across two study sites (one urban, one rural) in central Uganda. Eligible infants (n=126, age 6–11 completed months) with neurodevelopmental impairment (defined as a developmental quotient <70 on Griffiths Scales of Mental Development, and, or Hammersmith Infant Neurological Examination score <60) will be recruited and randomised to the intervention or standard care arm. Intervention arm families will receive the 10-modular, peer-facilitated, participatory, community-based programme over 6 months. Recruited families will be followed up at 6 and 12 months after recruitment, and assessors will be blinded to the trial allocation. The primary hypothesis is that the ABAaNA EIP is feasible and acceptable when compared with standard care. Primary outcomes of interest are feasibility (number recruited and randomised at baseline) and acceptability (protocol violation of arm allocation and number of sessions attended) and family and child quality of life. Guided by the study aim, the qualitative data analysis will use a data-led thematic framework approach. The findings will inform scalability and sustainability of the programme. ETHICS AND DISSEMINATION: The trial protocol has been approved by the relevant Ugandan and UK ethics committees. Recruited families will give written informed consent and we will follow international codes for ethics and good clinical practice. Dissemination will be through peer-reviewed publications, conference presentations and public engagement. TRIAL REGISTRATION NUMBER: ISRCTN44380971; protocol version 3.0, 19th February 2018. BMJ Publishing Group 2019-10-09 /pmc/articles/PMC6797334/ /pubmed/31601606 http://dx.doi.org/10.1136/bmjopen-2019-032705 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. 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 | Paediatrics Nampijja, Margaret Webb, Emily Nanyunja, Carol Sadoo, Samantha Nalugya, Ruth Nyonyintono, James Muhumuza, Anita Ssekidde, Moses Katumba, Kenneth Magnusson, Brooke Kabugo, Daniel Cowan, Frances M Martinez-Biarge, Miriam Zuurmond, Maria Morgan, Cathy Lester, Deborah Seeley, Janet Tann, Cally J Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol |
title | Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol |
title_full | Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol |
title_fullStr | Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol |
title_full_unstemmed | Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol |
title_short | Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol |
title_sort | randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in uganda: a study protocol |
topic | Paediatrics |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6797334/ https://www.ncbi.nlm.nih.gov/pubmed/31601606 http://dx.doi.org/10.1136/bmjopen-2019-032705 |
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