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

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?

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01542398
Enrollment
159
Registered
2012-03-02
Start date
2012-03-31
Completion date
2012-07-31
Last updated
2018-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological Distress

Keywords

community-based, war-affected, psychosocial support, family-focused, psychological distress, adolescents, Democratic Republic of Congo, family functioning, community functioning, daily functioning

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.

Interventions

BEHAVIORALFamily-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

Sponsors

Harvard School of Public Health (HSPH)
CollaboratorOTHER
Discover the Journey
CollaboratorUNKNOWN
Queen's University, Belfast
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* severe/violent behavioural problems * severe learning difficulties

Design outcomes

Primary

MeasureTime frameDescription
Reduction in Post-traumatic Stress Reaction Symptoms Among Participants1-week before intervention, 3-weeks laterTo 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.

Secondary

MeasureTime frameDescription
African Youth Psychosocial Assessment Inventory - Depression and Anxiety Subscalespre-intervention, 3 weeks laterInternalising 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).

Countries

Republic of the Congo

Participant flow

Participants by arm

ArmCount
Family-Focused Psychosocial Intervention
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
79
Waiting List Control80
Total159

Baseline characteristics

CharacteristicFamily-Focused Psychosocial InterventionWaiting List ControlTotal
Age, Continuous13.16 years
STANDARD_DEVIATION 2.85
13.76 years
STANDARD_DEVIATION 2.76
13.42 years
STANDARD_DEVIATION 2.79
Region of Enrollment
Congo
79 participants80 participants159 participants
Sex: Female, Male
Female
36 Participants35 Participants71 Participants
Sex: Female, Male
Male
43 Participants45 Participants88 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 790 / 80
other
Total, other adverse events
0 / 790 / 80
serious
Total, serious adverse events
0 / 790 / 80

Outcome results

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.

Time frame: 1-week before intervention, 3-weeks later

ArmMeasureGroupValue (MEAN)Dispersion
Family-Focused Psychosocial InterventionReduction in Post-traumatic Stress Reaction Symptoms Among ParticipantsPre-Intervention Mean Scores11.79 units on a scaleStandard Deviation 5.28
Family-Focused Psychosocial InterventionReduction in Post-traumatic Stress Reaction Symptoms Among ParticipantsPost-Intervention Mean Scores12.17 units on a scaleStandard Deviation 5.7
Waiting List Control GroupReduction in Post-traumatic Stress Reaction Symptoms Among ParticipantsPre-Intervention Mean Scores11.80 units on a scaleStandard Deviation 5.56
Waiting List Control GroupReduction in Post-traumatic Stress Reaction Symptoms Among ParticipantsPost-Intervention Mean Scores10.03 units on a scaleStandard Deviation 4.76
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).

Time frame: pre-intervention, 3 weeks later

ArmMeasureGroupValue (MEAN)Dispersion
Family-Focused Psychosocial InterventionAfrican Youth Psychosocial Assessment Inventory - Depression and Anxiety SubscalesPre-Intervention Scores14.88 units on a scaleStandard Deviation 7.07
Family-Focused Psychosocial InterventionAfrican Youth Psychosocial Assessment Inventory - Depression and Anxiety Subscales3 week Post-Intervention Scores12.09 units on a scaleStandard Deviation 6.26
Waiting List Control GroupAfrican Youth Psychosocial Assessment Inventory - Depression and Anxiety SubscalesPre-Intervention Scores13.53 units on a scaleStandard Deviation 6.19
Waiting List Control GroupAfrican Youth Psychosocial Assessment Inventory - Depression and Anxiety Subscales3 week Post-Intervention Scores11.57 units on a scaleStandard Deviation 5.36

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026