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:
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
  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?

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Queen's University, Belfast

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 16, 2014