Family Centered Developmental Intervention on Severely Acutely Malnourished Children

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Severly Acutely Malnourished Children

Intervention / Treatment
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* Behavioral: Play-based family centered stimulation
* Other: no intervention


Participation Criteria
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Eligibility Criteria
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SAM children who were admitted for medical treatment and nutritional rehabilitation after being confirmed by physicians to be severely acutely malnourished. Inclusion criteria were: children between 6 to 60 months of age 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 with a low mid upper arm circumference (MUAC), i.e., less than 110 mm with a length greater than 65 cm; or, having bilateral pitting edema, Exclusion criteria were: SAM children who were completely deaf or blind, who had complications that hinder mobility for play, whose primary caregiver was not able to provide stimulation due to physical or mental disability, who were from far or inaccessible distance for follow-up

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 66 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SAM intervention group<br>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. | Behavioral: Play-based family centered stimulation<br>* 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.<br>|
| Other: SAM control Group<br>The control children received routine medical treatment and nutritional rehabilitation services in hospital. Though they had access to playground facilities neither the control children nor their caregivers had access to the playroom materials and the basic orientation on child care, feeding and stimulation. | Other: no intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Language outcome | Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted. | baseline | 
| Language outcome | Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted. | at discharge from the hospital (on average at 2 weeks) | 
| Language outcome | Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted. | 6 months after discharge from hospital | 
| Personal-Social outcome | Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted. | baseline | 
| Personal-Social outcome | Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted. | at discharge from the hospital (on average at 2 weeks) | 
| Personal-Social outcome | Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted. | 6 months after discharge | 
| Fine motor outcome | Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted. | baseline | 
| Fine motor outcome | Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted. | at discharge from the hospital (on average at 2 weeks) | 
| Fine motor outcome | Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted. | 6 months after discharge | 
| Gross motor outcome | Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted. | baseline | 
| Gross motor outcome | Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted. | at discharge from the hospital (on average at 2 weeks) | 
| Gross motor outcome | Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted. | 6 months after discharge | 
| Social-emotional outcome | The 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 | baseline | 
| Social-emotional outcome | The 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 | at discharge from the hospital (on average at 2 weeks) | 
| Social-emotional outcome | The 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 | 6 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linear growth | Height/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. | baseline | 
| Linear growth | Height/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. | at discharge from the hospital (on average at 2 weeks) | 
| Linear growth | Height/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. | 6 months after discharge from hospital | 
| Nutritional status (Weight -for-age) | Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale. | baseline | 
| Nutritional status (Weight -for-age) | Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale. | at discharge from the hospital (on average at 2 weeks) | 
| Nutritional status (Weight -for-age) | Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale. | 6 months after discharge from hospital | 
| Nutritional status (Weight for height/length) | Weight-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. | baseline | 
| Nutritional status (Weight for height/length) | Weight-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. | at discharge from the hospital (on average at 2 weeks) | 
| Nutritional status (Weight for height/length) | Weight-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. | 6 months after discharge from hospital | 
| Nutritional status (Mid-upper-arm circumference) | Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape. | baseline | 
| Nutritional status (Mid-upper-arm circumference) | Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape. | at discharge from the hospital (on average at 2 weeks) | 
| Nutritional status (Mid-upper-arm circumference) | Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape. | 6 months after discharge from hospital |