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Completed

NCT Number: NCT03036176

Family Centered Developmental Intervention on Severely Acutely Malnourished Children

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.

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Key information

Age range

6 month–66 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Play-based family centered stimulation

Behavioral

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.

No intervention

Other

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.

Primary outcomes

  1. Language outcome

    Time frame: baseline

    Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.

  2. Language outcome

    Time frame: at discharge from the hospital (on average at 2 weeks)

    Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.

  3. Language outcome

    Time frame: 6 months after discharge from hospital

    Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.

  4. Personal-Social outcome

    Time frame: baseline

    Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.

  5. Personal-Social outcome

    Time frame: at discharge from the hospital (on average at 2 weeks)

    Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.

  6. Personal-Social outcome

    Time frame: 6 months after discharge

    Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.

  7. Fine motor outcome

    Time frame: baseline

    Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.

  8. Fine motor outcome

    Time frame: at discharge from the hospital (on average at 2 weeks)

    Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.

  9. Fine motor outcome

    Time frame: 6 months after discharge

    Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.

  10. Gross motor outcome

    Time frame: baseline

    Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.

  11. Gross motor outcome

    Time frame: at discharge from the hospital (on average at 2 weeks)

    Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.

  12. Gross motor outcome

    Time frame: 6 months after discharge

    Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.

  13. Social-emotional outcome

    Time frame: baseline

    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

  14. Social-emotional outcome

    Time frame: at discharge from the hospital (on average at 2 weeks)

    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

  15. Social-emotional outcome

    Time frame: 6 months after discharge

    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

Secondary outcomes

  1. Linear growth

    Time frame: baseline

    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.

  2. Linear growth

    Time frame: at discharge from the hospital (on average at 2 weeks)

    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.

  3. Linear growth

    Time frame: 6 months after discharge from hospital

    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.

  4. Nutritional status (Weight -for-age)

    Time frame: baseline

    Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.

  5. Nutritional status (Weight -for-age)

    Time frame: at discharge from the hospital (on average at 2 weeks)

    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. Nutritional status (Weight -for-age)

    Time frame: 6 months after discharge from hospital

    Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.

  7. Nutritional status (Weight for height/length)

    Time frame: baseline

    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.

  8. Nutritional status (Weight for height/length)

    Time frame: at discharge from the hospital (on average at 2 weeks)

    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.

  9. Nutritional status (Weight for height/length)

    Time frame: 6 months after discharge from hospital

    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.

  10. Nutritional status (Mid-upper-arm circumference)

    Time frame: baseline

    Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.

  11. Nutritional status (Mid-upper-arm circumference)

    Time frame: at discharge from the hospital (on average at 2 weeks)

    Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.

  12. Nutritional status (Mid-upper-arm circumference)

    Time frame: 6 months after discharge from hospital

    Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jimma University
  • PXL University College
  • University Ghent

Registry information

Official study title

"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"

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jan 30, 2017
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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