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Family Centered Developmental Intervention on Severely Acutely Malnourished Children

Primary Purpose

Severly Acutely Malnourished Children

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Play-based family centered stimulation
no intervention
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Severly Acutely Malnourished Children

Eligibility Criteria

6 Months - 66 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    SAM intervention group

    SAM control Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Language outcome
    Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.
    Language outcome
    Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.
    Language outcome
    Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.
    Personal-Social outcome
    Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.
    Personal-Social outcome
    Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.
    Personal-Social outcome
    Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.
    Fine motor outcome
    Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.
    Fine motor outcome
    Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.
    Fine motor outcome
    Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.
    Gross motor outcome
    Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.
    Gross motor outcome
    Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.
    Gross motor outcome
    Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.
    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
    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
    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

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    January 20, 2017
    Last Updated
    January 27, 2017
    Sponsor
    Hasselt University
    Collaborators
    Jimma University, University Ghent, PXL University College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03036176
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2011 (undefined)
    Primary Completion Date
    August 2012 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hasselt University
    Collaborators
    Jimma University, University Ghent, PXL University College

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severly Acutely Malnourished Children

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    339 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SAM intervention group
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    SAM control Group
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Play-based family centered stimulation
    Intervention Description
    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
    Other
    Intervention Name(s)
    no intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Language outcome
    Description
    Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.
    Time Frame
    baseline
    Title
    Language outcome
    Description
    Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.
    Time Frame
    at discharge from the hospital (on average at 2 weeks)
    Title
    Language outcome
    Description
    Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.
    Time Frame
    6 months after discharge from hospital
    Title
    Personal-Social outcome
    Description
    Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.
    Time Frame
    baseline
    Title
    Personal-Social outcome
    Description
    Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.
    Time Frame
    at discharge from the hospital (on average at 2 weeks)
    Title
    Personal-Social outcome
    Description
    Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.
    Time Frame
    6 months after discharge
    Title
    Fine motor outcome
    Description
    Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.
    Time Frame
    baseline
    Title
    Fine motor outcome
    Description
    Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.
    Time Frame
    at discharge from the hospital (on average at 2 weeks)
    Title
    Fine motor outcome
    Description
    Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.
    Time Frame
    6 months after discharge
    Title
    Gross motor outcome
    Description
    Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.
    Time Frame
    baseline
    Title
    Gross motor outcome
    Description
    Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.
    Time Frame
    at discharge from the hospital (on average at 2 weeks)
    Title
    Gross motor outcome
    Description
    Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.
    Time Frame
    6 months after discharge
    Title
    Social-emotional outcome
    Description
    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
    Time Frame
    baseline
    Title
    Social-emotional outcome
    Description
    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
    Time Frame
    at discharge from the hospital (on average at 2 weeks)
    Title
    Social-emotional outcome
    Description
    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
    Time Frame
    6 months after discharge
    Secondary Outcome Measure Information:
    Title
    Linear growth
    Description
    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.
    Time Frame
    baseline
    Title
    Linear growth
    Description
    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.
    Time Frame
    at discharge from the hospital (on average at 2 weeks)
    Title
    Linear growth
    Description
    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.
    Time Frame
    6 months after discharge from hospital
    Title
    Nutritional status (Weight -for-age)
    Description
    Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.
    Time Frame
    baseline
    Title
    Nutritional status (Weight -for-age)
    Description
    Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.
    Time Frame
    at discharge from the hospital (on average at 2 weeks)
    Title
    Nutritional status (Weight -for-age)
    Description
    Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.
    Time Frame
    6 months after discharge from hospital
    Title
    Nutritional status (Weight for height/length)
    Description
    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.
    Time Frame
    baseline
    Title
    Nutritional status (Weight for height/length)
    Description
    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.
    Time Frame
    at discharge from the hospital (on average at 2 weeks)
    Title
    Nutritional status (Weight for height/length)
    Description
    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.
    Time Frame
    6 months after discharge from hospital
    Title
    Nutritional status (Mid-upper-arm circumference)
    Description
    Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.
    Time Frame
    baseline
    Title
    Nutritional status (Mid-upper-arm circumference)
    Description
    Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.
    Time Frame
    at discharge from the hospital (on average at 2 weeks)
    Title
    Nutritional status (Mid-upper-arm circumference)
    Description
    Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.
    Time Frame
    6 months after discharge from hospital

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    66 Months
    Accepts Healthy Volunteers
    No
    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: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marita Granitzer, prof. dr.
    Organizational Affiliation
    Hasselt Univerity
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31521161
    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.
    Results Reference
    derived

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    Family Centered Developmental Intervention on Severely Acutely Malnourished Children

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