Enhanced Child Friendly Space Interventions for Children

Child Development Clinical Trial

Official title:

A Randomised Control Trial of Enhanced Child Friendly Space Interventions for Girls and Boys Affected by Conflict and Displacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03897894
• Other study ID #: AAAS1367
• Status: Completed
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: November 20, 2020

Study information

• Verified date: December 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2015
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Child, Only
• Mental Health Wellness 1
• Psychosocial Stressors

Intervention

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.

Locations

Country	Name	City	State
Uganda	World Vision West Nile Response Office	Arua

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Elrha, World Vision

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child and Youth Resilience Measure (CYRM-28)	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	Child PTSD Symptom Scale (CPSS) Part 1	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
Secondary	Child PTSD Symptom Scale (CPSS) Part 2	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
Secondary	Children's Hope Scale (CHS)	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
Secondary	Children's Revised Impact of Events Scale (CRIES-8)	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
Secondary	Short Mood and Feelings Questionnaire (S-MFQ)	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
Secondary	Emergency Developmental Assets Profile (EMDAP)	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

External Links

•   Project description on Donor Website