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Enhanced Child Friendly Space Interventions for Children

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ClinicalTrials.gov Identifier: NCT03897894
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborators:
Elrha
World Vision
Information provided by (Responsible Party):
Cassie Landers, Ed.D, MPH, Columbia University

Brief Summary:
A 3-arm randomised controlled trial will be conducted to compare the effectiveness of a new enhanced Child Friendly Space service package with the basic Child Friendly Space service implementation, and to a waitlist control condition, within the West Nile refugee response in Uganda.

Condition or disease Intervention/treatment Phase
Psychosocial Stressors Child, Only Mental Health Wellness 1 Child Development Behavioral: Child Friendly Space Not Applicable

Detailed Description:

A Child Friendly Space (CFS) is an acute phase humanitarian intervention designed to provide children with a safe, supportive, and stable environment early after the onset of crisis that will promote their social and emotional well-being, as well strengthen the existing systems of protection required to support children in reaching developmental milestones. Typically, CFSs house a range of structured and unstructured activities led by trained animators in a community-designated safe area.

The basic service package offers a mixture of recreational and non-formal education activities over a twelve-week period. Each session lasts around 1.5 - 3 hours. Structured activities offered include basic literacy and numeracy lessons, life skills exercises, health and hygiene sessions, and traditional song and dance. Many activities are centered around various forms of play that enable expression and age-appropriate skill development. Unstructured free play and playground time is allocated throughout the daily session.

The enhanced service package provides 40 sequential sessions selected by CFS program staff in advance and implemented over a twelve-week period. Activities are meant to build upon and reinforce one another and are organized into seven psychosocial themes: 1) Building community: "Our space together", 2) Emotional learning: "My feelings", 3) Wellbeing and coping: "Feeling good", 4) Social support: "My friends and family", 5) Relating to others: "Being a good friend", 6) Protection and boundaries: "My safety", and 7) Building on strengths: "All my supports". Each session takes approximately 1.5 - 2 hours to facilitate and will conclude with 1-1.5 hours unstructured free play time.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Randomised Control Trial of Enhanced Child Friendly Space Interventions for Girls and Boys Affected by Conflict and Displacement
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Enhanced Service Package
The enhanced service package provides 40 sequential sessions selected by CFS program staff in advance and implemented over a twelve-week period. Activities are meant to build upon and reinforce one another and are organized into seven psychosocial themes: 1) Building community: "Our space together", 2) Emotional learning: "My feelings", 3) Wellbeing and coping: "Feeling good", 4) Social support: "My friends and family", 5) Relating to others: "Being a good friend", 6) Protection and boundaries: "My safety", and 7) Building on strengths: "All my supports". Each session takes approximately 1.5 - 2 hours to facilitate and will conclude with 1-1.5 hours unstructured free play time.
Behavioral: Child Friendly Space
Child Friendly Spaces (CFS) are one of the most widely used interventions to provide Mental Health and Psychosocial Support (MHPSS) as well as provide a protective environment for children in humanitarian settings.

Experimental: Basic Service Package
The basic service package offers a mixture of recreational and non-formal education activities over a twelve-week period. Each session lasts around 1.5 - 3 hours. Structured activities offered include basic literacy and numeracy lessons, life skills exercises, health and hygiene sessions, and traditional song and dance. Many activities are centered around various forms of play that enable expression and age-appropriate skill development. Unstructured free play and playground time is allocated throughout the daily session.
Behavioral: Child Friendly Space
Child Friendly Spaces (CFS) are one of the most widely used interventions to provide Mental Health and Psychosocial Support (MHPSS) as well as provide a protective environment for children in humanitarian settings.

No Intervention: Control
Waitlist control will receive delayed treatment of intervention after the primary assessment period.



Primary Outcome Measures :
  1. Child and Youth Resilience Measure (CYRM-28) [ Time Frame: up to 1 hour from the start of a session ]
    A 28-item caregiver (for children aged 6-8 years) or child-reported (for children aged 9-14 years) measure that explores the resources that may bolster the resilience of children. Each item of the child self-report has response options rated on a 5-point scale ranging from 1 (Not at all) to 5 (A Lot). Higher scores are indicative of increased presence of resilience processes. Each item of the caregiver-reported measure has three response options - 1 (No), 2(Sometimes), and 3 (Yes). Higher scores are indicative of increased presence of resilience processes of the child (better outcome).


Secondary Outcome Measures :
  1. Child PTSD Symptom Scale (CPSS) Part 1 [ Time Frame: up to 1 hour from the start of a session ]
    A two-part 27-item measure of psychological distress that maps to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Post-traumatic Stress Disorder (PTSD). Part one features 20 PTSD symptom items rated on a 5-point scale of frequency and severity from 0 (not at all) to 4 (6 or more times a week). Scores on part one range from 0 to 80, with higher scores indicating greater psychological distress (more symptoms) and lower scores indicating a better outcome. This will be administered to children aged 9 to 14 years.

  2. Child PTSD Symptom Scale (CPSS) Part 2 [ Time Frame: up to 1 hour from the start of a session ]
    A two-part 27-item measure of psychological distress that maps to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Post-traumatic Stress Disorder (PTSD). Part two features 7 dichotomous functionality items from 0 (no) to 1 (yes). Scores on part two range from 0 to 7, with higher scores indicating greater daily functional impairment. This will be administered to children aged 9 to 14 years.

  3. Children's Hope Scale (CHS) [ Time Frame: up to 1 hour from the start of a session ]
    A 6-item measure of children's perception of agency and pathways thinking towards goals. The CHS measures goal-oriented thinking using six youth-appropriate items. Each item has response options rated on a six-point Likert-type scale ranging from one (None of the Time) to six (All of the Time). Higher scores are indicative of more positive goal-oriented thinking (greater hopefulness). This will be administered to children aged 9 to 14 years. Caregivers of children aged 6 to 8 years will be asked to answer on behalf of their child.

  4. Children's Revised Impact of Events Scale (CRIES-8) [ Time Frame: up to 1 hour from the start of a session ]
    A 8-item screening measure of intrusive and avoidant cognitions related to PTSD and is frequently used in evaluating stress reactions after traumatic experiences. Response options are rated on a 4-point scale from 1 (Not at all) to 4 (Often). Scores range from 8 to 32, with higher scores indicating PTSD symptoms consistent with intrusion and avoidance of the child and lower scores indicating lesser PTSD symptoms (better outcome). This will be administered to caregivers of children aged 6 to 8 years.

  5. Short Mood and Feelings Questionnaire (S-MFQ) [ Time Frame: up to 1 hour from the start of a session ]
    A 13-item screening measure for depression. Each item is rated on a 3-point Likert scale with response options of 0 (Not True), 1(Sometimes True), and 2 (True). Scores range from 0 to 26, with lower scores indicating the child is likely not suffering from depression (better outcome). This will be administered to caregivers of children aged 6 to 8 years.

  6. Emergency Developmental Assets Profile (EMDAP) [ Time Frame: up to 1 hour from the start of a session ]
    A 13-item measure of developmental assets essential for children to thrive into adulthood. Each item is answered on a four-point scale from 0 (Not at All/Rarely) to 3 (Extremely/Almost Always). Scores range from 0 to 30, with higher scores indicating the child has more developmental assets (better outcome). This will be administered to children aged 9 to 14 years.



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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary caregiver has a child between the ages 6-8
  • Child is between the ages of 9-14 years

Exclusion Criteria:

  • No child resides in the home between the ages of 6 and 14 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897894


Contacts
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Contact: Janna Metzler, DrPH 212-551-3029 jlm2200@cumc.columbia.edu

Locations
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Uganda
World Vision West Nile Response Office Recruiting
Arua, Uganda
Contact: Terry Saw, MPH         
Sponsors and Collaborators
Columbia University
Elrha
World Vision
Investigators
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Principal Investigator: Cassie Landers, PhD Columbia University

Additional Information:
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Responsible Party: Cassie Landers, Ed.D, MPH, Assistant Professor of Population and Family Health, Columbia University
ClinicalTrials.gov Identifier: NCT03897894     History of Changes
Other Study ID Numbers: AAAS1367
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cassie Landers, Ed.D, MPH, Columbia University:
resilience
child protection
child development