Improving early detection and intervention for young infants at high risk of neurodevelopmental delay and disability in Uganda

• Register: ISRCTN
• Last refreshed on: 17 October 2022
• Main ID: ISRCTN44380971
• Date of registration: 16/12/2017
• Prospective Registration: Yes
• Primary sponsor: MRC/UVRI Uganda Research Unit on AIDS
• Public title: Improving early detection and intervention for young infants at high risk of neurodevelopmental delay and disability in Uganda
• Scientific title: The ABAaNA early intervention pilot trial: a randomised feasibility trial of a facilitated, community-based participatory early intervention for young infants at high risk of neurodevelopmental delay and disability in Uganda
• Date of first enrolment: 08/01/2018
• Target sample size: 126
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN44380971
• Study type: Interventional
• Study design: Two-centre single blind randomised controlled trial with two parallel arms (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Uganda

Contacts

• Name: Maggie Nampijja

Key inclusion & exclusion criteria

Inclusion criteria:
Infants and their caregivers must satisfy the following inclusion criteria:
1. Infant aged 6-9 months
2. Infant has moderate-severe developmental impairment defined as a Developmental Quotient (DQ) on the Griffiths Mental Developmental Scales of <70 and/or HINE score <60
3. Informed written consent is provided by caregiver

Exclusion criteria:
1. Condition requiring inpatient treatment
2. Caregivers not willing or unable to attend the full programme
3. Main residence outside Nakaseke district or >20km from Mulago Hospital
4. No caregiver informed written consent
5. Accompanying parent or guardian does not speak or understand Luganda or English


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Neurodevelopmental impairment and disability
Nervous System Diseases
Neurodevelopmental impairment and disability

Intervention(s)

Children and their caregivers are randomised in a 1:1 ratio to receive either the ABAaNA early intervention programme or standard of care.

Intervention group:
The ABAaNA early intervention programme consists of a 10-modular parent training course delivered over a six-month period and includes two home visits to ensure translation of the skills and learning to the home environment. The program has previously been developed and piloted in Ugandan children using a pre and post-test observational design. Participatory group sessions with 6-10 families (mothers or (and) fathers)/other care-givers are conducted by trained facilitators, themselves parents of children with neurodisability. The content of the training includes positioning, feeding, communication, everyday activities, play, and shared experiences in the local community with a focus on empowering caregivers and the wider family, and an emphasis on peer support and learning. Facilitators receive comprehensive training from existing in-country master trainers established during the pilot study. Individual module sessions will be given every 3-4 weeks and, based on the pilot work, will last 2-3 hours including time for facilitated discussion.

Control group:
Participants in the control group receive the standard level of care.

The early intervention group receive a package involving 10 group training sessions for caregivers delivered over a six-month period (during which time control and case group participants will receive standard of care). Outcomes are assessed at the end of this six-month period (“programme completion”). All participants are then followed for a further six months, and outcomes assessed again at the

Primary Outcome(s)

1. Feasibility of participant recruitment and randomisation as assessed by the total number recruited and randomised to each arm at baseline. Qualitative tools including focus group discussions and in-depth interviews conducted at baseline, programme completion and at six months post-programme completion will also be used to capture information on feasibility
2. Acceptability of the early intervention programme amongst caregivers and health care workers as assessed by the protocol violation rate (protocol violations may result from participants in the intervention arm being treated as if they were in the control arm or vice versa) at programme completion. Qualitative tools including focus group discussions and in-depth interviews conducted at baseline, programme completion and at six months post-programme completion will also be used to capture information on acceptability
3. Acceptability of the early intervention programme among caregivers as assessed by number of sessions attended between baseline and programme completion
4. Quality of life as assessed using the scored, validated Pediatric Quality of Life, Family Impact module at baseline, programme completion and at six months post-programme completion

Secondary Outcome(s)

1. Child functioning as assessed by the Pediatric Evaluation Disability Inventory (PEDI) at baseline, programme completion and at six months post-programme completion
2. Cognitive function as measured using the Griffiths Mental Developmental Scales at baseline, programme completion and at six months post-programme completion
3. Growth and nutrition as measured using weight-for-age, height-for-age, weight-for-height, MUAC and head circumference at baseline, programme completion and at six months post-programme completion
4. Caregiver psychological distress assessed using the Self-Referral Questionnaire (SRQ) and the Parent Stress index (PSI) at baseline, programme completion and at six months post-programme completion
5. Caregiver child attachment is assessed using the Emotional Availability Scales (EAS) for observed emotional availability and the Maternal Responsiveness Instrument (MIR) for self-reported emotional availability at baseline, programme completion and at six months post-programme completion
6. Illness episodes and infant mortality is assessed using questionnaires delivered to the caregiver at baseline, programme completion and at six months post-programme completion
7. The quality of the home environment assessed using the Home Observation for the Measurement of the Environment (HOME) at baseline, programme completion and at six months post-programme completion

Secondary ID(s)

Version 1

Source(s) of Monetary Support

Saving Brains Grand Challenges Canada

Ethics review

Status:
Approval date:
Contact:

1. Uganda Virus Research Institute, 27/04/2017, ref: GC/127/17/04/596 2. Uganda National Council for Science and Technology, 29/05/2017, ref: HS2244 3. Mulago Hospital, 07/08/2017, ref: MREC 1205 4. London School of Hygiene & Tropical Medicine, 14/08/2017, ref: 14304

Results

• Results available: Yes
• Date Completed: 30/09/2019