A Phase 1 interventional study of Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention in Psychological Distress, sponsored by Queen's University, Belfast. Completed at 1 site in Congo. Open to participants aged 7 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-28.
Sponsored by Queen's University, Belfast · Phase 1, Interventional, and Treatment
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.
Queen's University, Belfast is the lead sponsor of 117 studies on the registry; 14 are open to participants now.
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Intervention Group
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
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
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
| Milestone | Family-Focused Psychosocial Intervention | Waiting List Control Group |
|---|---|---|
| Started | 79 | 80 |
| Post-intervention assessment | 78 | 80 |
| Completed | 71 | 67 |
| Not completed | 8 | 13 |
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.
| units on a scale | Family-Focused Psychosocial Intervention | Waiting List Control Group |
|---|---|---|
| Pre-Intervention Mean Scores | 11.79 ± 5.28 | 11.80 ± 5.56 |
| Post-Intervention Mean Scores | 12.17 ± 5.70 | 10.03 ± 4.76 |
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).
| units on a scale | Family-Focused Psychosocial Intervention | Waiting List Control |
|---|---|---|
| Pre-Intervention Scores | 14.88 ± 7.07 | 13.53 ± 6.19 |
| 3 week Post-Intervention Scores | 12.09 ± 6.26 | 11.57 ± 5.36 |
Collected over Participants were informally monitored (through thrice weekly check-ins with the village leaders who were supporting the intervention) to ensure that the study intervention was not causing harm or resulting in Adverse Events for people in either the intervention or waiting-list control group. No Adverse Events were reported to the team during the duration of the study or in the study month follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/79 (0%) | 0/79 (0%) | 0/79 (0%) |
| Waiting List Control Group | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) |
| Age, Continuous(years) | Family-Focused Psychosocial Intervention | Waiting List Control | Total |
|---|---|---|---|
| Mean | 13.16 ± 2.85 | 13.76 ± 2.76 | 13.42 ± 2.79 |
| Sex: Female, Male(Participants) | Family-Focused Psychosocial Intervention | Waiting List Control | Total |
|---|---|---|---|
| Female | 36 | 35 | 71 |
| Male | 43 | 45 | 88 |
| Region of Enrollment(participants) | Family-Focused Psychosocial Intervention | Waiting List Control | Total |
|---|---|---|---|
| Congo | 79 | 80 | 159 |
The record gives a start of Mar 2012, a primary completion of Apr 2012 and a completion of Jul 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2018, 6 years 8 months after primary completion.
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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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