A Family-based, Resilience-focused Intervention for War-affected Communities in North-eastern Democratic Republic of Congo
This study is enrolling participants by invitation only.
Sponsor:
Queen's University, Belfast
Collaborators:
Harvard School of Public Health
Discover the Journey
Information provided by (Responsible Party):
Paul O'Callaghan, Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT01542398
First received: February 21, 2012
Last updated: March 1, 2012
Last verified: February 2012
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Purpose
The main research question of the study is whether a family-based, life-skills focused psychosocial intervention is effective in reducing psychological distress and stigma and improving inter-personal relations and functioning among war-affected children in the Democratic Republic of Congo.
| Condition | Intervention | Phase |
|---|---|---|
|
Psychological Distress |
Behavioral: Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Title: Is a Family-based, Life Skills Focused Intervention Effective in Reducing Psychological Distress and Stigma and Improving Inter-personal Relations and Functioning Among Former LRA Abductees and Other War-affected Children in Their Community in Dungu, the Democratic Republic of Congo? |
Further study details as provided by Queen's University, Belfast:
Primary Outcome Measures:
- Reduction in Psychological Distress among participants confirmed by self-report and care-giver report [ Time Frame: 1-week before intervention, 3-weeks later, 3-months later ] [ Designated as safety issue: No ]Psychological distress will be measured using the Child Response Impact of Events Scale 8 and the African Youth Psychosocial Assessment Instrument (depression and anxiety and conduct subscales)
Secondary Outcome Measures:
- Improvement in Family Functioning confirmed by self-report [ Time Frame: 1-week before intervention, 3-weeks later and 3-months later ] [ Designated as safety issue: No ]Improvement in family functioning will be measured using an eight-item family functioning scale questionnaire
- Improvement in Community Functioning confirmed by self-report [ Time Frame: 1-week before intervention, 3-weeks later, 3-months later ] [ Designated as safety issue: No ]Community functioning will be measured using an 8-item community functioning scale and the pro-social scale of the African Youth Psychosocial Assessment Instrument
- Improvement in Daily Functioning confirmed by self-report [ Time Frame: 1-week before intervention, 3-weeks later, 3-months later ] [ Designated as safety issue: No ]Daily Functioning will be measured using the 11-item Youth Daily Task Functioning Questionnaire and examines how easy or difficult it is for young people to carry out common everyday tasks such as fetching water, collecting firewood or tending animals
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Family-Focused Psychosocial Intervention
Intervention Group
|
Behavioral: Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention
A 12-module manualised intervention focusing on reducing psychological distress, improving family and community functioning and boosting daily functioning of adolescents through the use of Mobile Cinema Screenings and task-based, participatory, group-sessions
|
| No Intervention: Waiting List Control |
Eligibility| Ages Eligible for Study: | 7 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- War-affected
- eastern Democratic Republic of Congo
- Formerly abducted child or vulnerable child
Exclusion Criteria:
- severe/violent behavioural problems
- severe learning difficulties
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542398
Locations
| Congo | |
| Dungu | |
| Dungu, Haut-Uele, Congo, DRC | |
Sponsors and Collaborators
Queen's University, Belfast
Harvard School of Public Health
Discover the Journey
Investigators
| Study Director: | Ciarán Shannon, BA, MA, DClin | British Psychological Society (Chartered Clinical Psychologist) |
More Information
No publications provided
| Responsible Party: | Paul O'Callaghan, Principal Investigator, Queen's University, Belfast |
| ClinicalTrials.gov Identifier: | NCT01542398 History of Changes |
| Other Study ID Numbers: | PREC 06-2012 |
| Study First Received: | February 21, 2012 |
| Last Updated: | March 1, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Queen's University, Belfast:
|
community-based war-affected psychosocial support family-focused psychological distress |
adolescents Democratic Republic of Congo family functioning community functioning daily functioning |
ClinicalTrials.gov processed this record on May 23, 2013