Family Centered Developmental Intervention on Severely Acutely Malnourished Children

NCT ID: NCT03036176

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 339 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

SAM intervention group

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.

Group Type: OTHER

Play-based family centered stimulation

Intervention Type: 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 control Group

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.

Group Type: OTHER

no intervention

Intervention Type: 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.

Interventions

Play-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.

Intervention Type: BEHAVIORAL

no 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 66 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jimma University

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: collaborator

PXL University College

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

prof. dr. Marita Granitzer

prof.dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marita Granitzer, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt Univerity

References

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.

Reference Type: DERIVED

PMID: 31521161 (View on PubMed)

Other Identifiers

EPFPS-2010

Identifier Type: -

Identifier Source: org_study_id