Neurodevelopmental impairment and disability Nervous System Diseases Neurodevelopmental impairment and disability
Conditions
Interventions
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
Sponsors
MRC/UVRI Uganda Research Unit on AIDS
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Uganda
Outcome results
None listed