A Family-based, Resilience-focused Intervention for War-affected Communities in North-eastern Democratic Republic of Congo

Psychological Distress Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542398
• Other study ID #: PREC 06-2012
• Status: Completed
• Phase: Phase 1
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: June 2018
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 99 Years

Eligibility

Inclusion Criteria:

• War-affected

• eastern Democratic Republic of Congo

• Formerly abducted child or vulnerable child

Exclusion Criteria:

• severe/violent behavioural problems

• severe learning difficulties

Related Conditions & MeSH terms

• Psychological Distress

Intervention

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

Locations

Country	Name	City	State
Congo	Dungu	Dungu	Haut-Uele

Sponsors (3)

Lead Sponsor	Collaborator
Queen's University, Belfast	Discover the Journey, Harvard School of Public Health

Country where clinical trial is conducted

Congo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Post-traumatic Stress Reaction Symptoms Among Participants	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	African Youth Psychosocial Assessment Inventory - Depression and Anxiety Subscales	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