Family Centered Developmental Intervention on Severely Acutely Malnourished Children

NCT03036176 | Completed

• 1 other identifier: EPFPS-2010
• Study Type: interventional
• Target: 339
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Severly Acutely Malnourished Children

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (12)

• Linear growth

  baseline

• Linear growth

  at discharge from the hospital (on average at 2 weeks)

• Linear growth

  6 months after discharge from hospital

• Nutritional status (Weight -for-age)

  baseline

• Nutritional status (Weight -for-age)

  at discharge from the hospital (on average at 2 weeks)

Study Arms (2)

SAM intervention group

OTHER

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

SAM control Group

OTHER

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

Interventions

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.

SAM intervention group

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.

SAM control Group

Eligibility Criteria

• Age: 6 Months - 66 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead
• Jimma University: collaborator
• University Ghent: collaborator
• PXL University College: collaborator

Related Publications (1)

• Abessa TG, Worku BN, Wondafrash M, Girma T, Valy J, Lemmens J, Bruckers L, Kolsteren P, Granitzer M. Effect of play-based family-centered psychomotor/psychosocial stimulation on the development of severely acutely malnourished children under six in a low-income setting: a randomized controlled trial. BMC Pediatr. 2019 Sep 14;19(1):336. doi: 10.1186/s12887-019-1696-z.

  PMID: 31521161 DERIVED

Study Officials

• Marita Granitzer, prof. dr.

  Hasselt Univerity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.dr.

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 30, 2017
• Study Start: February 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2013
• Last Updated: January 30, 2017

Record last verified: 2017-01