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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01542398
Recruitment Status : Unknown
Verified February 2012 by Paul O'Callaghan, Queen's University, Belfast.
Recruitment status was:  Enrolling by invitation
First Posted : March 2, 2012
Last Update Posted : March 2, 2012
Sponsor:
Collaborators:
Harvard School of Public Health
Discover the Journey
Information provided by (Responsible Party):
Paul O'Callaghan, Queen's University, Belfast

Brief Summary:
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 or disease Intervention/treatment Phase
Psychological Distress Behavioral: Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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?
Study Start Date : March 2012
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : July 2012

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Improvement in Family Functioning confirmed by self-report [ Time Frame: 1-week before intervention, 3-weeks later and 3-months later ]
    Improvement in family functioning will be measured using an eight-item family functioning scale questionnaire

  2. Improvement in Community Functioning confirmed by self-report [ Time Frame: 1-week before intervention, 3-weeks later, 3-months later ]
    Community functioning will be measured using an 8-item community functioning scale and the pro-social scale of the African Youth Psychosocial Assessment Instrument

  3. Improvement in Daily Functioning confirmed by self-report [ Time Frame: 1-week before intervention, 3-weeks later, 3-months later ]
    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



Information from the National Library of Medicine

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Boutique Cardigan Boutique Signature Boutique Cardigan Studio Boutique Studio Signature Signature Studio Cardigan Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542398


Locations
Congo
Dungu
Dungu, Haut-Uele, Congo, DRC
Sponsors and Collaborators
Queen's University, Belfast
Harvard School of Public Health
Discover the Journey
Boutique Signature Signature Cardigan Cardigan Boutique Studio Studio Boutique Boutique Signature Studio Cardigan Investigators
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Study Director: Ciarán Shannon, BA, MA, DClin British Psychological Society (Chartered Clinical Psychologist)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: March 2, 2012
Last Verified: February 2012

Keywords provided by Paul O'Callaghan, 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