NCT01542398

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

December 28, 2018

Completed
Last Updated

December 28, 2018

Status Verified

June 1, 2018

Enrollment Period

1 month

First QC Date

February 21, 2012

Results QC Date

October 22, 2014

Last Update Submit

June 21, 2018

Conditions

Psychological Distress

Keywords

community-basedwar-affectedpsychosocial supportfamily-focusedpsychological distressadolescentsDemocratic Republic of Congofamily functioningcommunity functioningdaily functioning

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • African Youth Psychosocial Assessment Inventory - Depression and Anxiety Subscales

    pre-intervention, 3 weeks later

Study Arms (2)

Family-Focused Psychosocial Intervention

EXPERIMENTAL

Intervention Group

Behavioral: Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention

Waiting List Control

NO INTERVENTION

Interventions

Family-Focused, Community-Based, Resilience-Targetting Psychosocial InterventionBEHAVIORAL

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

Family-Focused Psychosocial Intervention

Eligibility Criteria

Age7 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • War-affected
  • eastern Democratic Republic of Congo
  • Formerly abducted child or vulnerable child

You may not qualify if:

  • severe/violent behavioural problems
  • severe learning difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dungu

Dungu, Haut-Uele, DRC, Republic of the Congo

Location

Related Publications (1)

  • O'Callaghan P, Branham L, Shannon C, Betancourt TS, Dempster M, McMullen J. A pilot study of a family focused, psychosocial intervention with war-exposed youth at risk of attack and abduction in north-eastern Democratic Republic of Congo. Child Abuse Negl. 2014 Jul;38(7):1197-207. doi: 10.1016/j.chiabu.2014.02.004. Epub 2014 Mar 15.

    PMID: 24636358DERIVED

Results Point of Contact

Title
Dr Paul O'Callaghan
Organization
Queen's University, Belfast
pocallaghan02@qub.ac.uk
+44 7501 43 46 32

Study Officials

  • Ciarán Shannon, BA, MA, DClin

    British Psychological Society (Chartered Clinical Psychologist)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2012

First Posted

March 2, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2012

Study Completion

July 1, 2012

Last Updated

December 28, 2018

Results First Posted

December 28, 2018

Record last verified: 2018-06

Locations

RE(1)