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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
339

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasselt University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Ghent
Jimma University
PXL University College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Severly Acutely Malnourished Children

Clinical Trials on Play-based family centered stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings