- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01542398
A Family-based, Resilience-focused Intervention for War-affected Communities in North-eastern Democratic Republic of Congo
June 21, 2018 updated by: Paul O'Callaghan, Queen's University, Belfast
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?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
159
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Haut-Uele
-
Dungu, Haut-Uele, Congo, DRC
- Dungu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- War-affected
- eastern Democratic Republic of Congo
- Formerly abducted child or vulnerable child
Exclusion Criteria:
- severe/violent behavioural problems
- severe learning difficulties
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Waiting List Control
|
|
Experimental: Family-Focused Psychosocial Intervention
Intervention Group
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in Post-traumatic Stress Reaction Symptoms Among Participants
Time Frame: 1-week before intervention, 3-weeks later
|
To assess post-traumatic stress reaction symptoms the 8-item Impact of Events Scale (CRIES-8) was used (Yule, 1997).
Respondents indicating how frequently they experience a symptom on a 4-point Likert scale (0, 1, 2, 3).
Thus the minimum score was 0 while the maximum score was 24.
A high score indicates a high level of post-traumatic stress symptoms.
This 8-item CRIES, which was designed for children over 7 years of age, has an identical factor structure to the 22-item version (Yule, 1997) which was previously validated with a sample of 1,046 war-affected adolescents in the eastern Democratic Republic of Congo (Mels, Derluyn, Broekaert & Rosseel, 2010) (internal reliability range: 0·79 to 0·84; Cronbach's alpha for the total scale: 0·93).
In the current study, internal consistency was 0·557.
|
1-week before intervention, 3-weeks later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
African Youth Psychosocial Assessment Inventory - Depression and Anxiety Subscales
Time Frame: pre-intervention, 3 weeks later
|
Internalising symptoms were assessed using the African Youth Psychosocial Assessment Instrument (AYPA) (Betancourt et al., 2009).This 17 item Likert (0 = minimum, 51 = maximum) measure was developed in northern Uganda after extensive qualitative consultation with young people, caregivers and mental health workers.
A high score on the AYPA indicates a high level of internalizing symptoms.
It is the only African developed, validated questionnaire available, had been used in separate studies with war-affected children in the DR Congo (McMullen et al., 2013; O'Callaghan, McMullen, Shannon, Rafferty & Black; 2013) and includes symptoms of distress which do not appear in Western-developed measures (e.g.
muttering to oneself, feeling pain in your heart, sitting with your head in your hand etc.).
Test-retest reliability (carried out with a subset of 30 participants) for the AYPA was 0·91, inter-rater reliability was 0·58 (n = 26) and internal consistency was 0·787 (internalising symptoms).
|
pre-intervention, 3 weeks later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ciarán Shannon, BA, MA, DClin, British Psychological Society (Chartered Clinical Psychologist)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
February 21, 2012
First Submitted That Met QC Criteria
March 1, 2012
First Posted (Estimate)
March 2, 2012
Study Record Updates
Last Update Posted (Actual)
December 28, 2018
Last Update Submitted That Met QC Criteria
June 21, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PREC 06-2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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