- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03036176
Family Centered Developmental Intervention on Severely Acutely Malnourished Children
January 27, 2017 updated by: prof. dr. Marita Granitzer, Hasselt University
"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"
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
339
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
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.
|
Other: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Language outcome
Time Frame: baseline
|
Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.
|
baseline
|
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.
|
at discharge from the hospital (on average at 2 weeks)
|
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.
|
6 months after discharge from hospital
|
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.
|
baseline
|
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.
|
at discharge from the hospital (on average at 2 weeks)
|
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.
|
6 months after discharge
|
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.
|
baseline
|
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.
|
at discharge from the hospital (on average at 2 weeks)
|
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.
|
6 months after discharge
|
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.
|
baseline
|
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.
|
at discharge from the hospital (on average at 2 weeks)
|
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.
|
6 months after discharge
|
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
|
baseline
|
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
|
at discharge from the hospital (on average at 2 weeks)
|
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
|
6 months after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline
|
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.
|
at discharge from the hospital (on average at 2 weeks)
|
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.
|
6 months after discharge from hospital
|
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.
|
baseline
|
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.
|
at discharge from the hospital (on average at 2 weeks)
|
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.
|
6 months after discharge from hospital
|
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.
|
baseline
|
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.
|
at discharge from the hospital (on average at 2 weeks)
|
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.
|
6 months after discharge from hospital
|
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.
|
baseline
|
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.
|
at discharge from the hospital (on average at 2 weeks)
|
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.
|
6 months after discharge from hospital
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marita Granitzer, prof. dr., Hasselt Univerity
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
January 20, 2017
First Submitted That Met QC Criteria
January 27, 2017
First Posted (Estimate)
January 30, 2017
Study Record Updates
Last Update Posted (Estimate)
January 30, 2017
Last Update Submitted That Met QC Criteria
January 27, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPFPS-2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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