<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02988180</url>
  </required_header>
  <id_info>
    <org_study_id>DGSC-2015</org_study_id>
    <nct_id>NCT02988180</nct_id>
  </id_info>
  <brief_title>Intervention on Development and Growth at Children in Poverty</brief_title>
  <acronym>RAI</acronym>
  <official_title>Developmental and Growth Status of Children (6-60 Months of Age) in Extreme Poverty in Jimma Town of Ethiopia: Effects of Developmental Stimulation - RAI (Risk Analysis and Intervention)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jimma University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>VLIR-UOS (Vlaamse Interuniversitaire Raad).</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hasselt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children in extreme poverty lack adequate care and face increased health risks. The earlier&#xD;
      poverty strikes in the developmental process, the more deleterious and long-lasting its&#xD;
      effects. There is, however, growing evidence that early interventions can prevent the&#xD;
      negative consequences. Such interventions are effective, particularly when they are of high&#xD;
      quality, organized at home and parents are involved. Recently, baseline assessment of&#xD;
      developmental and nutritional status of SOS children and children in extreme poverty in Jimma&#xD;
      region of South-West Ethiopia revealed that these children have developmental problems in&#xD;
      language, motor, social-emotional skills and nutritional status. The impact of play-oriented&#xD;
      stimulation activities integrated into the existing SOS basic program, on developmental&#xD;
      outcomes, has never been investigated in this context. The main objective of the study is,&#xD;
      therefore, to evaluate the impact of play-oriented stimulation integrated into the basic SOS&#xD;
      program on the developmental outcomes of children living with foster families. This was done&#xD;
      by comparing the intervention children with their age-matched children (control), not&#xD;
      receiving the stimulation package. It was hypothesized that this package would significantly&#xD;
      improve the developmental skills of these children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Personal-social outcome</measure>
    <time_frame>baseline</time_frame>
    <description>Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Personal-social outcome</measure>
    <time_frame>month 3</time_frame>
    <description>Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Personal-social outcome</measure>
    <time_frame>month 6</time_frame>
    <description>Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fine motor outcome</measure>
    <time_frame>baseline</time_frame>
    <description>Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fine motor outcome</measure>
    <time_frame>3 months</time_frame>
    <description>Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fine motor outcome</measure>
    <time_frame>6 months</time_frame>
    <description>Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>gross motor outcome</measure>
    <time_frame>baseline</time_frame>
    <description>Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>gross motor outcome</measure>
    <time_frame>3 months</time_frame>
    <description>Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>gross motor outcome</measure>
    <time_frame>6 months</time_frame>
    <description>Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>language outcome</measure>
    <time_frame>baseline</time_frame>
    <description>Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>language outcome</measure>
    <time_frame>3 months</time_frame>
    <description>Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>language outcoome</measure>
    <time_frame>6 months</time_frame>
    <description>Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social-emotional outcome</measure>
    <time_frame>baseline</time_frame>
    <description>Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social-emotional outcome</measure>
    <time_frame>3 months</time_frame>
    <description>Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social-emotional outcome</measure>
    <time_frame>6 months</time_frame>
    <description>Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>weight</measure>
    <time_frame>baseline</time_frame>
    <description>A child's weight was measured by using a calibrated electronic weighing scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>weight</measure>
    <time_frame>3 months</time_frame>
    <description>A child's weight was measured by using a calibrated electronic weighing scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>weight</measure>
    <time_frame>6 months</time_frame>
    <description>A child's weight was measured by using a calibrated electronic weighing scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>baseline</time_frame>
    <description>For children under two years of age, a length measuring board on a flat table was used. 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Child Malnutrition</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Children in the intervention group received basic services such as family-home, food, clothing, health care, protection and education for older children. In addition, there received play-based developmental stimulation integrated into the services.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The age-matched control children received the basic services such as family-home, food, clothing, health care, protection and education. However, they were not provided with the play-based developmental stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>basic services</intervention_name>
    <description>The age-matched control children received the basic services such as family-home, food, clothing, health care, protection and education. However, they were not provided with the play-based developmental stimulation.</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>the play-based developmental stimulation</intervention_name>
    <description>Children in the intervention group received basic services such as family-home, food, clothing, health care, protection and education for older children. In addition, there received play-based developmental stimulation integrated into the services.</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children who were selected by the SOS children's village as lacking parental care and&#xD;
             receive basic services;&#xD;
&#xD;
          -  Children living in Jimma town;&#xD;
&#xD;
          -  Children from 3 months to 59 months of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with observable physical disabilities which hinders mobility;&#xD;
&#xD;
          -  Children with severe mental retardation;&#xD;
&#xD;
          -  Children with discernable hearing and visual impairments.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>59 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Teklu Gemechu Abessa</last_name>
    <role>Study Chair</role>
    <affiliation>Jimma University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mekitie Wondafrash, nutritionist</last_name>
    <role>Study Chair</role>
    <affiliation>Jimma University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patrick Kolsteren, prof.dr</last_name>
    <role>Study Chair</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Berhanu Nigussie Worku, psychologist</last_name>
    <role>Study Chair</role>
    <affiliation>Jimma University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ghent University</name>
      <address>
        <city>Ghent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>2. Jimma University</name>
      <address>
        <city>Jimma</city>
        <country>Ethiopia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Ethiopia</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>prof. dr. Marita Granitzer</investigator_full_name>
    <investigator_title>prof.dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Child Nutrition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02988180
org study id: DGSC-2015
nct id: NCT02988180
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Children in extreme poverty lack adequate care and face increased health risks. The earlier
      poverty strikes in the developmental process, the more deleterious and long-lasting its
      effects. There is, however, growing evidence that early interventions can prevent the
      negative consequences. Such interventions are effective, particularly when they are of high
      quality, organized at home and parents are involved. Recently, baseline assessment of
      developmental and nutritional status of SOS children and children in extreme poverty in Jimma
      region of South-West Ethiopia revealed that these children have developmental problems in
      language, motor, social-emotional skills and nutritional status. The impact of play-oriented
      stimulation activities integrated into the existing SOS basic program, on developmental
      outcomes, has never been investigated in this context. The main objective of the study is,
      therefore, to evaluate the impact of play-oriented stimulation integrated into the basic SOS
      program on the developmental outcomes of children living with foster families. This was done
      by comparing the intervention children with their age-matched children (control), not
      receiving the stimulation package. It was hypothesized that this package would significantly
      improve the developmental skills of these children.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Investigator)
measure: Personal-social outcome
time frame: baseline
description: Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis
measure: Personal-social outcome
time frame: month 3
description: Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis
measure: Personal-social outcome
time frame: month 6
description: Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis
measure: fine motor outcome
time frame: baseline
description: Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis
measure: fine motor outcome
time frame: 3 months
description: Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis
measure: fine motor outcome
time frame: 6 months
description: Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis
measure: gross motor outcome
time frame: baseline
description: Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis
measure: gross motor outcome
time frame: 3 months
description: Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis
measure: gross motor outcome
time frame: 6 months
description: Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis
measure: language outcome
time frame: baseline
description: Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis
measure: language outcome
time frame: 3 months
description: Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis
measure: language outcoome
time frame: 6 months
description: Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis
measure: Social-emotional outcome
time frame: baseline
description: Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children
measure: Social-emotional outcome
time frame: 3 months
description: Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children
measure: Social-emotional outcome
time frame: 6 months
description: Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children
measure: weight
time frame: baseline
description: A child's weight was measured by using a calibrated electronic weighing scale.
measure: weight
time frame: 3 months
description: A child's weight was measured by using a calibrated electronic weighing scale.
measure: weight
time frame: 6 months
description: A child's weight was measured by using a calibrated electronic weighing scale.
measure: Height
time frame: baseline
description: For children under two years of age, a length measuring board on a flat table was used. 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.
measure: Height
time frame: 3 months
description: 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.
measure: Height
time frame: 6 months
description: 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.
arm group label: intervention group
arm group type: Other
description: Children in the intervention group received basic services such as family-home, food, clothing, health care, protection and education for older children. In addition, there received play-based developmental stimulation integrated into the services.
arm group label: control group
arm group type: Other
description: The age-matched control children received the basic services such as family-home, food, clothing, health care, protection and education. However, they were not provided with the play-based developmental stimulation.
intervention type: Other
intervention name: basic services
description: The age-matched control children received the basic services such as family-home, food, clothing, health care, protection and education. However, they were not provided with the play-based developmental stimulation.
arm group label: control group
arm group label: intervention group
intervention type: Other
intervention name: the play-based developmental stimulation
description: Children in the intervention group received basic services such as family-home, food, clothing, health care, protection and education for older children. In addition, there received play-based developmental stimulation integrated into the services.
arm group label: intervention group
criteria: 
gender: All
minimum age: 3 Months
maximum age: 59 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Teklu Gemechu Abessa
role: Study Chair
affiliation: Jimma University
last name: Mekitie Wondafrash, nutritionist
role: Study Chair
affiliation: Jimma University
last name: Patrick Kolsteren, prof.dr
role: Study Chair
affiliation: University Ghent
last name: Berhanu Nigussie Worku, psychologist
role: Study Chair
affiliation: Jimma University
facility: 
facility: 
country: Belgium
country: Ethiopia
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: prof. dr. Marita Granitzer
investigator title: prof.dr.
mesh term: Malnutrition
mesh term: Child Nutrition Disorders
sharing ipd: Undecided