Psychological DistressPhase 1NCT01542398

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

A Phase 1 study testing Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention in people with Psychological Distress, run by Queen's University, Belfast at 1 site in Republic of the Congo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 7 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Psychological Distress
What is being tested?: Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 159 participants
Where: 1 siteRepublic of the Congo
Study dates: Mar 2012to Jul 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 99 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

severe/violent behavioural problems
severe learning difficulties

Trial locations and contacts

1 site in 1 country.

Republic of the Congo1 site

Dungu
Dungu, Haut-Uele, DRC

Other trials in Republic of the Congo

About this study

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?

Conditions: Psychological Distress
Being tested: Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention
Keywords: community-based, war-affected, psychosocial support, family-focused, psychological distress, adolescents, Democratic Republic of Congo, family functioning, community functioning, daily functioning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01542398
Study group	Role	What they receive
Family-Focused Psychosocial Intervention	Experimental	Intervention Group Receives: Behavioral: Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention
Waiting List Control	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1-week before intervention, 3-weeks later

Secondary outcomes (1)

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).
Measured: pre-intervention, 3 weeks later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Jul 2012

First posted2 Mar 2012 (estimated)
Study startMar 2012
Primary completionApr 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Psychological DistressStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01542398
Sponsor's protocol ID: PREC 06-2012
Status last verified: Jun 2018
First submitted: 21 Feb 2012
Last updated: 28 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 24636358

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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?
ClinicalTrials.gov ID: NCT01542398
Acronym / sponsor ID: PREC 06-2012
Conditions: Psychological Distress
Keywords: community-based, war-affected, psychosocial support, family-focused, psychological distress, adolescents, Democratic Republic of Congo, family functioning
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Queen's University, BelfastUniversity, hospital or other
Collaborators: Harvard School of Public Health (HSPH), Discover the Journey
Study start: Mar 2012
Primary completion: Apr 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 2 Mar 2012 (estimated)
Results: Posted 28 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Family-Focused Psychosocial Intervention	Experimental	Behavioral: Family-Focused, Community-Based, Resilience-Targetting Psychosocial InterventionIntervention Group
Waiting List Control	No intervention	–

Who may qualify

Ages: 7 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

severe/violent behavioural problems
severe learning difficulties

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Family-Focused, Community-Based, Resilience-Targetting Psychosocial InterventionA 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	Behavioural	Family-Focused Psychosocial Intervention

Primary outcome

Reduction in Post-traumatic Stress Reaction Symptoms Among Participants
Time frame: 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.

1 secondary outcome

African Youth Psychosocial Assessment Inventory - Depression and Anxiety Subscales
Time frame: pre-intervention, 3 weeks later

Results and safety

Results posted to the registry on 28 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Family-Focused Psychosocial Intervention	79	71
Waiting List Control Group	80	67

Primary outcome: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants

Time frame: 1-week before intervention, 3-weeks later. Mean (Standard Deviation). Unit: units on a scale

Measure	Family-Focused Psychosocial Intervention n = 79	Waiting List Control Group n = 80
Pre-Intervention Mean Scores	11.79 (5.28)	11.80 (5.56)
Post-Intervention Mean Scores	12.17 (5.70)	10.03 (4.76)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Group	0 of 79 (0%)	0 of 79 (0%)	0 of 79
Waiting List Control Group	0 of 80 (0%)	0 of 80 (0%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24636358O'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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ciarán Shannon, BA, MA, DClin study director

British Psychological Society (Chartered Clinical Psychologist)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (time frame: 1-week before intervention, 3-weeks later). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01542398, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2018.