Clinical trial NCT03072433: An Intervention for Primary Caregivers to Improve Outcomes in Children With Severe Malnutrition
Official title: The Effect of an Intervention Program for Primary Caregivers on the Development of Children With Severe Malnutrition: A Cluster Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Malnutrition
Keywords: child malnutrition
child development
counseling
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: University of Malawi
First posted: 2017-03-07
Enrollment: 181
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This cluster-randomized controlled trial will evaluate the effectiveness of a four-day hospital-based intervention program for primary caregivers of children with severe malnutrition.

Detailed description: Mortality rates remain high in hospitalized children with severe malnutrition and long-term impairments in child development exist in children that do survive. Hospitalized children with severe malnutrition will be allocated to an intervention or standard of care group in each one-week cycle. The intervention package consists of a counseling and support program that includes three modules: 1) psychosocial stimulation; 2) nutrition and feeding; and 3) water, sanitation and hygiene. Assessments will be done at baseline (t=0) and follow-up (t=6 months). The primary outcome is child development, which will be assessed using the Malawi Developmental Assessment Tool, a validated tool for gross and fine motor, language, and social development.

Eligibility criteria: Inclusion Criteria:

* Child 6-59 months of age with severe malnutrition
* Child admitted to hospital because of severe malnutritionwith medical complications as defined by the current World Health Organization guidelines or has no appetite if there are no complications
* Primary caregiver (self-identified) present at hospital.

Exclusion Criteria:

* Primary caregiver declined to give informed consent;
* Child with a known terminal illness (i.e. in the opinion of the treating physician the child is likely to die within six months)
* Child requires a surgical procedure.

Primary outcomes:
measure: Malawi Developmental Assessment Tool Score
timeFrame: 6 months post-discharge from hospital
Secondary outcomes:
measure: Nutritional status based on: mid-upper arm circumference (MUAC)
timeFrame: 6 months post-discharge from hospital
measure: Nutritional status based on: World Health Organization (WHO) z-scores
timeFrame: 6 months post-discharge from hospital
measure: Nutritional status based on: nutritionally-induced bilateral pitting oedema
timeFrame: 6 months post-discharge from hospital
measure: Duration of hospital stay
timeFrame: During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)
measure: Appetite
timeFrame: During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)
measure: Clinical deterioration
timeFrame: During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)
measure: Readmission
timeFrame: Within 6 months post-discharge from hospital
measure: Mortality
timeFrame: Within 6 months post-discharge from hospital
Other outcomes:
measure: Self Reporting Questionnaire (SRQ-20)
timeFrame: 6 months post-discharge from hospital
measure: Home Observation for Measurement of the Environment (HOME) Inventory
timeFrame: 6 months post-discharge from hospital
measure: Primary caregiver knowledge, attitudes, and practices
timeFrame: 6 months post-discharge from hospital
measure: Participant engagement
timeFrame: Day one of the intervention during hospital stay
measure: Participant adherence
timeFrame: Across the four days of the intervention during hospital stay
Locations:
city: Blantyre
country: Malawi
facility: Queen Elizabeth Central Hospital
Study officials:
affiliation: The Hospital for Sick Children
name: Robert Bandsma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daniel AI, Bwanali M, Tenthani JC, Gladstone M, Voskuijl W, Potani I, Ziwoya F, Chidzalo K, Mbale E, Heath A, Bourdon C, Njirammadzi J, van den Heuvel M, Bandsma RHJ. A Mixed-Methods Cluster-Randomized Controlled Trial of a Hospital-Based Psychosocial Stimulation and Counseling Program for Caregivers and Children with Severe Acute Malnutrition. Curr Dev Nutr. 2021 Jul 21;5(8):nzab100. doi: 10.1093/cdn/nzab100. eCollection 2021 Aug.
citation: Daniel AI, van den Heuvel M, Gladstone M, Bwanali M, Voskuijl W, Bourdon C, Potani I, Fernandes S, Njirammadzi J, Bandsma RHJ. A mixed methods feasibility study of the Kusamala Program at a nutritional rehabilitation unit in Malawi. Pilot Feasibility Stud. 2018 Sep 24;4:151. doi: 10.1186/s40814-018-0347-8. eCollection 2018.
citation: Daniel AI, van den Heuvel M, Voskuijl WP, Gladstone M, Bwanali M, Potani I, Bourdon C, Njirammadzi J, Bandsma RHJ. The Kusamala Program for primary caregivers of children 6-59 months of age hospitalized with severe acute malnutrition in Malawi: study protocol for a cluster-randomized controlled trial. Trials. 2017 Nov 17;18(1):550. doi: 10.1186/s13063-017-2299-3.