Randomised controlled pilot feasibility trial of an early intervention programme for young infants with
Margaret Nampijja1, Emily Webb2, Carol Nanyunja1
1Social Aspects of Health Programme, MRC/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda.
Insights
This study assessed the feasibility and acceptability of a group participatory early intervention program for infants with neurodevelopmental impairment in Uganda. Findings will guide future scalability and sustainability of this community-based approach.
Area of Science:
- Global health
- Developmental pediatrics
- Public health interventions
Background:
- Early intervention programmes (EIPs) for infants with neurodevelopmental impairment are understudied, particularly in low-income countries.
- There is a need to evaluate accessible and sustainable EIPs in diverse settings.
Purpose of the Study:
- To evaluate the feasibility and acceptability of the ABAaNA EIP, a group participatory early intervention program.
- To assess the ABAaNA EIP's impact on family and child quality of life in Uganda.
Main Methods:
- Pilot feasibility, single-blinded, randomised controlled trial in Uganda (urban and rural sites).
- 126 infants (6-11 months) with neurodevelopmental impairment randomized to ABAaNA EIP or standard care.
- 6-month intervention with 6 and 12-month follow-ups; feasibility and acceptability primary outcomes.
Main Results:
- The study aims to determine feasibility (recruitment, randomization) and acceptability (protocol adherence, attendance).
- Qualitative data will explore family experiences and inform program scalability.
- Primary hypothesis: ABAaNA EIP is feasible and acceptable compared to standard care.
Conclusions:
- The findings will inform the scalability and sustainability of the ABAaNA EIP in Uganda.
- This study contributes to understanding effective early interventions for neurodevelopmental impairment in low-resource settings.
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.
