Psychosocial StressorsNCT03897894
Enhanced Child Friendly Space Interventions for Children
A study testing Child Friendly Space in people with Psychosocial Stressors and Child, Only, run by Columbia University at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosocial Stressors, Child, Only, Mental Health Wellness 1
- What is being tested?
- Child Friendly Space
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,015 participants
- Where
- 1 siteUganda
- Study dates
- 28 May 2019to 20 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary caregiver has a child between the ages 6-8
- Child is between the ages of 9-14 years
Who cannot join
- No child resides in the home between the ages of 6 and 14 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Control Trial of Enhanced Child Friendly Space Interventions for Girls and Boys Affected by Conflict and Displacement
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.
Read the 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.
- Being tested
- Child Friendly Space
- Keywords
- resilience, child protection, child development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child Friendly SpaceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Child Friendly Space |
| Control | No intervention | Waitlist control will receive delayed treatment of intervention after the primary assessment period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 1 hour from the start of a session
Secondary outcomes (6)
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.
Measured: up to 1 hour from the start of a session
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.
Measured: up to 1 hour from the start of a session
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.
Measured: up to 1 hour from the start of a session
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.
Measured: up to 1 hour from the start of a session
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.
Measured: up to 1 hour from the start of a session
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.
Measured: up to 1 hour from the start of a session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start28 May 2019
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychosocial StressorsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Elrha, World Vision
- Responsible party
- Principal investigator, Cassie Landers, Ed.D, MPH, Columbia University
- Investigators
- Cassie Landers, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897894
- Sponsor's protocol ID
- AAAS1367
- Status last verified
- Dec 2020
- First submitted
- 29 Mar 2019
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36593181
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial of Enhanced Child Friendly Space Interventions for Girls and Boys Affected by Conflict and Displacement
- ClinicalTrials.gov ID
- NCT03897894
- Acronym / sponsor ID
- AAAS1367
- Keywords
- resilience, child protection, child development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,015 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Elrha, World Vision
- Study start
- 28 May 2019 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enhanced Service Package | Experimental | Behavioral: Child Friendly SpaceThe 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. |
| Basic Service Package | Experimental | Behavioral: Child Friendly SpaceThe 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. |
| Control | No intervention | –Waitlist control will receive delayed treatment of intervention after the primary assessment period. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Primary caregiver has a child between the ages 6-8
- Child is between the ages of 9-14 years
Key exclusion criteria (1 listed)
- No child resides in the home between the ages of 6 and 14 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Child Friendly SpaceChild 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. | Behavioural | Basic Service Package, Enhanced Service Package |
Primary outcome
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).
6 secondary outcomes
Child PTSD Symptom Scale (CPSS) Part 1
Time frame: 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
Children's Hope Scale (CHS)
Time frame: 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
Short Mood and Feelings Questionnaire (S-MFQ)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Derived from this study: PubMed 36593181Metzler 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.
- Project description on Donor WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cassie Landers, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Child Friendly Space in people with Psychosocial Stressors and Child, Only, run by Columbia University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child and Youth Resilience Measure (CYRM-28) (time frame: up to 1 hour from the start of a session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03897894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.