- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03897894
Enhanced Child Friendly Space Interventions for Children
A Randomised Control Trial of Enhanced Child Friendly Space Interventions for Girls and Boys Affected by Conflict and Displacement
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Arua, Uganda
- World Vision West Nile Response Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
up to 1 hour from the start of a session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to 1 hour from the start of a session
|
|
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.
|
up to 1 hour from the start of a session
|
|
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.
|
up to 1 hour from the start of a session
|
|
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.
|
up to 1 hour from the start of a session
|
|
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.
|
up to 1 hour from the start of a session
|
|
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.
|
up to 1 hour from the start of a session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cassie Landers, PhD, Columbia University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AAAS1367
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.