Clinical trial NCT03036176: Family Centered Developmental Intervention on Severely Acutely Malnourished Children
Official 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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severly Acutely Malnourished Children
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jimma University
name: University Ghent
name: PXL University College
First posted: 2017-01-30
Enrollment: 339
Sex: ALL
Minimum age (years): 6
Maximum age (years): 66
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Language outcome
timeFrame: baseline
measure: Language outcome
timeFrame: at discharge from the hospital (on average at 2 weeks)
measure: Language outcome
timeFrame: 6 months after discharge from hospital
measure: Personal-Social outcome
timeFrame: baseline
measure: Personal-Social outcome
timeFrame: at discharge from the hospital (on average at 2 weeks)
measure: Personal-Social outcome
timeFrame: 6 months after discharge
measure: Fine motor outcome
timeFrame: baseline
measure: Fine motor outcome
timeFrame: at discharge from the hospital (on average at 2 weeks)
measure: Fine motor outcome
timeFrame: 6 months after discharge
measure: Gross motor outcome
timeFrame: baseline
measure: Gross motor outcome
timeFrame: at discharge from the hospital (on average at 2 weeks)
measure: Gross motor outcome
timeFrame: 6 months after discharge
measure: Social-emotional outcome
timeFrame: baseline
measure: Social-emotional outcome
timeFrame: at discharge from the hospital (on average at 2 weeks)
measure: Social-emotional outcome
timeFrame: 6 months after discharge
Secondary outcomes:
measure: Linear growth
timeFrame: baseline
measure: Linear growth
timeFrame: at discharge from the hospital (on average at 2 weeks)
measure: Linear growth
timeFrame: 6 months after discharge from hospital
measure: Nutritional status (Weight -for-age)
timeFrame: baseline
measure: Nutritional status (Weight -for-age)
timeFrame: at discharge from the hospital (on average at 2 weeks)
measure: Nutritional status (Weight -for-age)
timeFrame: 6 months after discharge from hospital
measure: Nutritional status (Weight for height/length)
timeFrame: baseline
measure: Nutritional status (Weight for height/length)
timeFrame: at discharge from the hospital (on average at 2 weeks)
measure: Nutritional status (Weight for height/length)
timeFrame: 6 months after discharge from hospital
measure: Nutritional status (Mid-upper-arm circumference)
timeFrame: baseline
measure: Nutritional status (Mid-upper-arm circumference)
timeFrame: at discharge from the hospital (on average at 2 weeks)
measure: Nutritional status (Mid-upper-arm circumference)
timeFrame: 6 months after discharge from hospital
Other outcomes:
Locations:
Study officials:
affiliation: Hasselt Univerity
name: Marita Granitzer, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.