NCT03897894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,015

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 28, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

1.5 years

First QC Date

March 29, 2019

Last Update Submit

December 4, 2020

Conditions

Keywords

resiliencechild protectionchild development

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Child PTSD Symptom Scale (CPSS) Part 1

    up to 1 hour from the start of a session

  • Child PTSD Symptom Scale (CPSS) Part 2

    up to 1 hour from the start of a session

  • Children's Hope Scale (CHS)

    up to 1 hour from the start of a session

  • Children's Revised Impact of Events Scale (CRIES-8)

    up to 1 hour from the start of a session

  • Short Mood and Feelings Questionnaire (S-MFQ)

    up to 1 hour from the start of a session

  • +1 more secondary outcomes

Study Arms (3)

Enhanced Service Package

EXPERIMENTAL

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

Basic Service Package

EXPERIMENTAL

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

Control

NO INTERVENTION

Waitlist control will receive delayed treatment of intervention after the primary assessment period.

Interventions

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.

Basic Service PackageEnhanced Service Package

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

World Vision West Nile Response Office

Arua, Uganda

Location

Related Publications (1)

  • Metzler J, Saw T, Nono D, Kadondi A, Zhang Y, Leu CS, Gabriel A, Savage K, Landers C. Improving adolescent mental health and protection in humanitarian settings: longitudinal findings from a multi-arm randomized controlled trial of child-friendly spaces among South Sudanese refugees in Uganda. J Child Psychol Psychiatry. 2023 Jun;64(6):907-917. doi: 10.1111/jcpp.13746. Epub 2023 Jan 2.

Related Links

Study Officials

  • Cassie Landers, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Population and Family Health

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 1, 2019

Study Start

May 28, 2019

Primary Completion

November 20, 2020

Study Completion

November 20, 2020

Last Updated

December 8, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations