Trial Outcomes & Findings for A Family-based, Resilience-focused Intervention for War-affected Communities in North-eastern Democratic Republic of Congo (NCT NCT01542398)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

159 participants

Primary outcome timeframe

1-week before intervention, 3-weeks later

Results posted on

2018-12-28

Participant Flow

Participant milestones

Participant milestones
Measure	Family-Focused Psychosocial Intervention Intervention Group Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention: An 8-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	Waiting List Control Group Waiting List Control Group of Adolescents who received the intervention once it was shown to be effective for the Intervention Group
Overall Study STARTED	79	80
Overall Study Post-Intervention Assessment	78	80
Overall Study COMPLETED	71	67
Overall Study NOT COMPLETED	8	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Family-Focused Psychosocial Intervention n=79 Participants Intervention Group 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	Waiting List Control n=80 Participants	Total n=159 Participants Total of all reporting groups
Age, Continuous	13.16 years STANDARD_DEVIATION 2.85 • n=5 Participants	13.76 years STANDARD_DEVIATION 2.76 • n=7 Participants	13.42 years STANDARD_DEVIATION 2.79 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	35 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	45 Participants n=7 Participants	88 Participants n=5 Participants
Region of Enrollment Congo	79 participants n=5 Participants	80 participants n=7 Participants	159 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family-Focused Psychosocial Intervention n=79 Participants Intervention Group Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention: An 8-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	Waiting List Control Group n=80 Participants Waiting List Control Group of Adolescents who received the intervention once it was shown to be effective for the Intervention Group
Reduction in Post-traumatic Stress Reaction Symptoms Among Participants Pre-Intervention Mean Scores	11.79 units on a scale Standard Deviation 5.28	11.80 units on a scale Standard Deviation 5.56
Reduction in Post-traumatic Stress Reaction Symptoms Among Participants Post-Intervention Mean Scores	12.17 units on a scale Standard Deviation 5.70	10.03 units on a scale Standard Deviation 4.76

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Family-Focused Psychosocial Intervention n=79 Participants Intervention Group Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention: An 8-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	Waiting List Control Group n=80 Participants Waiting List Control Group of Adolescents who received the intervention once it was shown to be effective for the Intervention Group
African Youth Psychosocial Assessment Inventory - Depression and Anxiety Subscales Pre-Intervention Scores	14.88 units on a scale Standard Deviation 7.07	13.53 units on a scale Standard Deviation 6.19
African Youth Psychosocial Assessment Inventory - Depression and Anxiety Subscales 3 week Post-Intervention Scores	12.09 units on a scale Standard Deviation 6.26	11.57 units on a scale Standard Deviation 5.36

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waiting List Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Paul O'Callaghan

Queen's University, Belfast

Phone: +44 7501 43 46 32

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place