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

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.

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

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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