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Family Centered Developmental Intervention on Severely Acutely Malnourished Children

Effects of a Play-based Family Centered Psychomotor/Psychosocial Stimulation on Recovery of Severely Malnourished Children of 6-60 Months of Age During Nutritional Rehabilitation in the Jimma Zone of Ethiopia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03036176
Enrollment
339
Registered
2017-01-30
Start date
2011-02-28
Completion date
2013-09-30
Last updated
2017-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severly Acutely Malnourished Children

Brief summary

Children with severe acute malnutrition (SAM) are at serious risks that compromise their growth and development. Studies have shown the benefits of psychosocial intervention in mitigating the negative consequences of SAM. However, such intervention studies have targeted the critical period in child development and thus focused on children under three years of age. Dietary rehabilitation is usually included as part of the intervention package. Moreover, these young children in such studies customarily obtain more care than older ones and have access to breast milk, more frequent interaction with mother and other caregivers in the family. Therefore, effects of psychosocial interventions targeting such age groups may be different for older children. Much is not known if children older than three years of benefit from similar interventions, and if family-based psychomotor/psychosocial intervention can benefit SAM children in low income contexts such as Ethiopia where access to balanced diet remains hardly possible. In Ethiopia, one of the poorest countries in the world, many children are admitted to hospital for treatment due to SAM. The nutritional rehabilitation unit at hospitals provide dietary treatment to the SAM children who are also treated for related illnesses and complications. Once discharged from hospital, however, the SAM children return to the same poor home environments with inadequate care and unbalanced diets. The main objective of this study was to evaluate the effect of play-based family-centered psychomotor/psychosocial stimulation on linear growth, nutritional status and developmental outcomes of under-six SAM children in the Jimma Zone, south west Ethiopia. This was done by randomly assigning the SAM children admitted to Jimma University's Specialized Referral Teaching Hospital into control and intervention groups. Both groups were receiving the routine medical and dietary treatment services. The intervention group additionally received play-based psychomotor/psychosocial stimulation. Caregivers, supported by periodic visits made to their homes, continued the simulation. Measurements were taken after six months of home follow-up. It was hypothesized that the intervention would significantly improve some of the developmental skills of these children, and that the effect may be age-dependent.

Interventions

BEHAVIORALPlay-based family centered stimulation

Children in the intervention group received routine medical treatment and nutritional rehabilitation services in hospital; their primary caregivers were given basic orientations on child care, feeding and nutrition. Children attended play-based stimulation sessions in which trained nurses demonstrated caregivers on how to stimulate the SAM child using play materials and facilities at playroom and playground of the hospital. After discharge from hospital, they were followed up at home and visited three times over a period of six months. During the visits, new play materials were provided and caregivers were shown how to use them to stimulate the SAM child.

OTHERno intervention

On the other hand, the control SAM group did not receive the guided psychomotor/psychosocial stimulation services although they had access to the playground facilities. Both the intervention and the control groups received all the routine medical care and dietary rehabilitation services at the hospital.

Sponsors

Jimma University
CollaboratorOTHER
University Ghent
CollaboratorOTHER
PXL University College
CollaboratorOTHER
Hasselt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 66 Months
Healthy volunteers
No

Inclusion criteria

SAM children who were admitted for medical treatment and nutritional rehabilitation after being confirmed by physicians to be severely acutely malnourished. Inclusion criteria were: 1. children between 6 to 60 months of age 2. of Transition Phase i.e., Phase II (no medical complications) and, whose wasting was severe (weight for height or weight for length less than 70% of the median on National Centre for Health Statistics of USA; or 3. with a low mid upper arm circumference (MUAC), i.e., less than 110 mm with a length greater than 65 cm; or, 4. having bilateral pitting edema,

Exclusion criteria

were: SAM children 1. who were completely deaf or blind, 2. who had complications that hinder mobility for play, 3. whose primary caregiver was not able to provide stimulation due to physical or mental disability, 4. who were from far or inaccessible distance for follow-up

Design outcomes

Primary

MeasureTime frameDescription
Social-emotional outcomebaselineThe Ages and Stages questionnaire: Social emotional (ASQ:SE) was used to test Social emotional outcome & a child's total behavior score was obtained by adding up scores on each of the items
Language outcomebaselineDenver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.
Personal-Social outcomebaselineDenver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.
Fine motor outcomebaselineDenver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.
Gross motor outcomebaselineDenver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.

Secondary

MeasureTime frameDescription
Nutritional status (Weight -for-age)baselineWeight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.
Nutritional status (Weight for height/length)baselineWeight-for-height/length z score (for under five children) and body-max-index-for age z score (for children above five years) were used to determine nutritional status.
Nutritional status (Mid-upper-arm circumference)baselineMid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.
Linear growthbaselineHeight/length-for-age z score was used to determine linear growth. For children under two years of age, a length measuring board on a flat table was used. The height of a child above two years of age was measured by using a portable stadiometer.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026