Severly Acutely Malnourished ChildrenNCT03036176
Family Centered Developmental Intervention on Severely Acutely Malnourished Children
A study testing Play-based family centered stimulation in people with Severly Acutely Malnourished Children, run by Hasselt University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 66 months
- Conditions the study is for
- Severly Acutely Malnourished Children
- What is being tested?
- Play-based family centered stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 66 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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,
Who cannot join
- 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
About this study
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"
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
- Being tested
- Play-based family centered stimulation, no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play-based family centered stimulationBehavioural
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 interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language outcome
Denver II-Jimma was used to test language outcome \& the total number of items successfully performed was counted.
Measured: baseline
Language outcome
Denver II-Jimma was used to test language outcome \& the total number of items successfully performed was counted.
Measured: 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.
Measured: 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.
Measured: baseline
Personal-Social outcome
Denver II-Jimma was used to test Personal-social outcome \& the total number of items successfully performed was counted.
Measured: 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.
Measured: 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.
Measured: baseline
Fine motor outcome
Denver II-Jimma was used to test Fine motor outcome \& the total number of items successfully performed was counted.
Measured: 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.
Measured: 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.
Measured: baseline
Gross motor outcome
Denver II-Jimma was used to test Gross motor outcome \& the total number of items successfully performed was counted.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after discharge
Secondary outcomes (12)
Linear growth
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.
Measured: baseline
Linear growth
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.
Measured: at discharge from the hospital (on average at 2 weeks)
Linear growth
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.
Measured: 6 months after discharge from hospital
Nutritional status (Weight -for-age)
Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.
Measured: baseline
Nutritional status (Weight -for-age)
Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.
Measured: at discharge from the hospital (on average at 2 weeks)
Nutritional status (Weight -for-age)
Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.
Measured: 6 months after discharge from hospital
Nutritional status (Weight for height/length)
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.
Measured: baseline
Nutritional status (Weight for height/length)
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.
Measured: at discharge from the hospital (on average at 2 weeks)
Nutritional status (Weight for height/length)
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.
Measured: 6 months after discharge from hospital
Nutritional status (Mid-upper-arm circumference)
Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.
Measured: baseline
Nutritional status (Mid-upper-arm circumference)
Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.
Measured: at discharge from the hospital (on average at 2 weeks)
Nutritional status (Mid-upper-arm circumference)
Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.
Measured: 6 months after discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startFeb 2011
- Primary completionAug 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severly Acutely Malnourished ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jimma University, University Ghent, PXL University College
- Responsible party
- Principal investigator, prof. dr. Marita Granitzer, Hasselt University
- Investigators
- Marita Granitzer, prof. dr., Principal investigator, Hasselt Univerity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036176
- Sponsor's protocol ID
- EPFPS-2010
- Status last verified
- Jan 2017
- First submitted
- 20 Jan 2017
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31521161
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT03036176
- Acronym / sponsor ID
- EPFPS-2010
- Conditions
- Severly Acutely Malnourished Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jimma University, University Ghent, PXL University College
- Study start
- Feb 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAM intervention group | Other | Behavioral: Play-based family centered stimulationChildren 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 | Other | Other: no interventionThe 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. |
Who may qualify
- Ages
- 6 to 66 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Play-based family centered stimulationChildren 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. | Behavioural | SAM intervention group |
| no interventionOn 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. | Other | SAM control Group |
Primary outcome
Language outcome
Time frame: baseline
Denver II-Jimma was used to test language outcome \& the total number of items successfully performed was counted.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
12 secondary outcomes
Linear growth
Time frame: baseline
Linear growth
Time frame: at discharge from the hospital (on average at 2 weeks)
Linear growth
Time frame: 6 months after discharge from hospital
Nutritional status (Weight -for-age)
Time frame: baseline
Nutritional status (Weight -for-age)
Time frame: at discharge from the hospital (on average at 2 weeks)
Nutritional status (Weight -for-age)
Time frame: 6 months after discharge from hospital
Nutritional status (Weight for height/length)
Time frame: baseline
Nutritional status (Weight for height/length)
Time frame: at discharge from the hospital (on average at 2 weeks)
Nutritional status (Weight for height/length)
Time frame: 6 months after discharge from hospital
Nutritional status (Mid-upper-arm circumference)
Time frame: baseline
Nutritional status (Mid-upper-arm circumference)
Time frame: at discharge from the hospital (on average at 2 weeks)
Nutritional status (Mid-upper-arm circumference)
Time frame: 6 months after discharge from hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Derived from this study: PubMed 31521161Abessa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marita Granitzer, prof. dr. principal investigator
Hasselt Univerity
Questions about this trial
What is this clinical trial studying?
A study testing Play-based family centered stimulation in people with Severly Acutely Malnourished Children, run by Hasselt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Language outcome (time frame: baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03036176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.