Stress Disorders, Post-TraumaticNCT01509872
Psychological and Psychosocial Intervention With War-Affected Children
A study testing Trauma Focused Cognitive Behavioral Therapy and Child Friendly Space in people with Stress Disorders, Post-Traumatic and Depression, run by Queen's University, Belfast at 1 site in Republic of the Congo.
Trial summary
The investigators are interested in knowing whether a group-based, trauma-focused intervention (Trauma Focused Cognitive Behavioral Therapy) is superior to a more general, non trauma-focused, psychosocial intervention (Child Friendly Spaces) in reducing post-traumatic stress, depression and anxiety and conduct… Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Depression, Anxiety
- What is being tested?
- Trauma Focused Cognitive Behavioral Therapy and Child Friendly Space
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRepublic of the Congo
- Study dates
- Oct 2011to Apr 2012
- Phase
- Interventional
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- under 18 years of age,
- witness to a violent event involving a real or perceived direct threat to life,
- ability to attend a 3-week intervention
Who cannot join
- psychosis,
- mental retardation,
- inability to understand Swahili,
- severe emotional \& behavioral problems that made group participation impossible
Trial locations and contacts
1 site in 1 country.
Republic of the Congo1 site
Child Friendly Space
Mwenga, South Kivu
About this study
Official title: An RCT Comparing Trauma-Focused Cognitive Behavioral Therapy (a Specific Psychological Intervention) and A Child Friendly Space (a Non-trauma Focused Psychosocial Intervention) in Reducing Psychological Distress Among War-affected Children
The investigators are interested in knowing whether a group-based, trauma-focused intervention (Trauma Focused Cognitive Behavioral Therapy) is superior to a more general, non trauma-focused, psychosocial intervention (Child Friendly Spaces) in reducing post-traumatic stress, depression and anxiety and conduct problems and increasing pro-social behavior among war-affected children in the Democratic Republic of Congo.
- Being tested
- Trauma Focused Cognitive Behavioral Therapy, Child Friendly Space
- Keywords
- Trauma-Focused Cognitive Behavior Therapy, War-affected Children, Post-traumatic Stress Symptoms, Psychosocial Distress
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Focused Cognitive Behavioral TherapyBehavioural
9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy
Child Friendly SpaceBehavioural
9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention
| Study group | Role | What they receive |
|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy | Experimental | Trauma-Focused Cognitive Behaviour Therapy (Cohen, Mannarino, Deblinger, 2006; Smith and Saunders, 2005) is a child-friendly, manualised psychological intervention for children who experience nightmares, flashbacks, anxiety, anger, social isolation, poor concentration or self-blame after experiencing or witnessing a violent and terrifying life event (e.g. rape, murder, abduction etc). This intervention was culturally modified for use with war-affected children. Receives: Behavioral: Trauma Focused Cognitive Behavioral Therapy |
| A Child Friendly Space | Active comparator | A Child Friendly Space is a psychosocial intervention combining creative (e.g. art), imaginative (e.g. drama), physical (e.g. football), communicative (e.g. group discussions) and manipulative activities (e.g. story telling). It aids children's natural development by providing a safe place for children to learn, express themselves, grow and develop, supported by trained animators and peer educators. Receives: Behavioral: Child Friendly Space |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index
The UCLA PTSD Reaction Index is a self-report questionnaire that measures exposure to traumatic events and assesses post-tramatic stress symptoms in school-age children and adolescents. The Congolese Swahili version used in the study had 22 items and assesses the frequency of occurrence of PTSD symptoms during the past week (rated from 0 = none of the time to 4 = most of the time). The scale ranged from 0 (no symptoms) to 88 (highest score possible). Although no cut-off score was used, the higher the score of the scale the higher the number of PTSD symptoms experienced.
Measured: baseline, 3 week post-intervention and 6-month follow up
Secondary outcomes (3)
Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument
The African Youth Psychosocial Assessment Instrument is a self-report questionnaire that measures internalizing, externalizing, conduct and pro-social (daily life functioning) skills symptoms. The Congolese Swahili version of the AYPA contained 19 questions on internalizing symptoms and assesses the frequency of occurrence of internalizing symptoms during the past week (rated from 0 = none of the time to 4 = most of the time). The lowest score obtainable on the measure was 0, while the highest score obtainable was 76. Although no cut-off score was used, the higher the score on the scale, the greater the psychosocial distress being reported.
Measured: baseline, 3 week post-intervention and 6 month follow up
Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument
The African Youth Psychosocial Assessment Instrument is a self-report questionnaire that measures internalizing, externalizing, conduct and pro-social (daily life functioning) skills symptoms. The Congolese Swahili version of the AYPA contained 10 questions about symptoms of conduct disorder and assesses the frequency of occurrence of externalizing symptoms during the past week (rated from 0 = none of the time to 4 = most of the time). The lowest score obtainable on the measure was 0, while the highest score obtainable was 40. Although no cut-off score was used, the higher the score on the scale, the greater the psychosocial adjustment difficulties being reported.
Measured: baseline, 3-week post-intervention, 6-month follow up
Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument
The African Youth Psychosocial Assessment Instrument is a self-report questionnaire that measures internalizing, externalizing, conduct and pro-social (daily life functioning) skills symptoms. The Congolese Swahili version of the AYPA contained 8 questions about pro-social behavior and assesses the frequency of occurrence of positive behaviors (e.g. sharing with others, listening to others and elders etc.) during the past week (rated from 0 = none of the time to 4 = most of the time). The lowest score obtainable on the measure was 0, while the highest score obtainable was 32. Although no cut-off score was used, the higher the score on the scale, the more pro-social the individual's behavior is.
Measured: baseline, 3-week post-intervention, 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionApr 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.
- Other trials for Stress Disorders, Post-TraumaticStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Transcultural Psychosocial Organization Nepal, UNICEF
- Responsible party
- Principal investigator, Paul O'Callaghan, Queen's University, Belfast
- Investigators
- Dr Ciarán Shannon, BA, MA, DClin, Study director, British Psychological Society (Chartered Clinical Psychologist)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509872
- Sponsor's protocol ID
- PREC73-2011
- Status last verified
- Apr 2019
- First submitted
- 6 Jan 2012
- Last updated
- 9 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT Comparing Trauma-Focused Cognitive Behavioral Therapy (a Specific Psychological Intervention) and A Child Friendly Space (a Non-trauma Focused Psychosocial Intervention) in Reducing Psychological Distress Among War-affected Children
- ClinicalTrials.gov ID
- NCT01509872
- Acronym / sponsor ID
- PREC73-2011
- Keywords
- Trauma-Focused Cognitive Behavior Therapy, War-affected Children, Post-traumatic Stress Symptoms, Psychosocial Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Transcultural Psychosocial Organization Nepal, UNICEF
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 Jan 2012 (estimated)
- Results
- Posted 9 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are interested in knowing whether a group-based, trauma-focused intervention (Trauma Focused Cognitive Behavioral Therapy) is superior to a more general, non trauma-focused, psychosocial intervention (Child Friendly Spaces) in reducing post-traumatic stress, depression and anxiety and conduct problems and increasing pro-social behavior among war-affected children in the Democratic Republic of Congo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy | Experimental | Behavioral: Trauma Focused Cognitive Behavioral TherapyTrauma-Focused Cognitive Behaviour Therapy (Cohen, Mannarino, Deblinger, 2006; Smith and Saunders, 2005) is a child-friendly, manualised psychological intervention for children who experience nightmares, flashbacks, anxiety, anger, social isolation, poor concentration or self-blame after experiencing or witnessing a violent and terrifying life event (e.g. rape, murder, abduction etc). This intervention was culturally modified for use with war-affected children. |
| A Child Friendly Space | Active comparator | Behavioral: Child Friendly SpaceA Child Friendly Space is a psychosocial intervention combining creative (e.g. art), imaginative (e.g. drama), physical (e.g. football), communicative (e.g. group discussions) and manipulative activities (e.g. story telling). It aids children's natural development by providing a safe place for children to learn, express themselves, grow and develop, supported by trained animators and peer educators. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- under 18 years of age,
- witness to a violent event involving a real or perceived direct threat to life,
- ability to attend a 3-week intervention
Key exclusion criteria (4 listed)
- psychosis,
- mental retardation,
- inability to understand Swahili,
- severe emotional \& behavioral problems that made group participation impossible
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 |
|---|---|---|
| Trauma Focused Cognitive Behavioral Therapy9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy | Behavioural | Trauma-Focused Cognitive Behavioral Therapy |
| Child Friendly Space9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention | Behavioural | A Child Friendly Space |
Primary outcome
Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index
Time frame: baseline, 3 week post-intervention and 6-month follow up
The UCLA PTSD Reaction Index is a self-report questionnaire that measures exposure to traumatic events and assesses post-tramatic stress symptoms in school-age children and adolescents. The Congolese Swahili version used in the study had 22 items and assesses the frequency of occurrence of PTSD symptoms during the past week (rated from 0 = none of the time to 4 = most of the time). The scale ranged from 0 (no symptoms) to 88 (highest score possible). Although no cut-off score was used, the higher the score of the scale the higher the number of PTSD symptoms experienced.
3 secondary outcomes
Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument
Time frame: baseline, 3 week post-intervention and 6 month follow up
Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument
Time frame: baseline, 3-week post-intervention, 6-month follow up
Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument
Time frame: baseline, 3-week post-intervention, 6-month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dr 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?
A study testing Trauma Focused Cognitive Behavioral Therapy and Child Friendly Space in people with Stress Disorders, Post-Traumatic and Depression, run by Queen's University, Belfast at 1 site in Republic of the Congo.
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 4 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 9 Apr 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2019). 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?
Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (time frame: baseline, 3 week post-intervention and 6-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2019.