Post-traumatic Stress DisorderPhase 2NCT01494831
Randomized Control Trial of Group Intervention With Former War-affected Boys in the Democratic Republic of Congo
A Phase 2 study testing TF-CBT in people with Post-traumatic Stress Disorder and Depression, run by Queen's University, Belfast.
Trial summary
The purpose of this study is to evaluate, in a randomised control trial (RCT), the effectiveness of group-based, trauma-focused Cognitive Behaviour Therapy (TF-CBT) in reducing psychological distress in former child soldiers and other war-affected children in the Democratic Republic of Congo (DRC). Read more about this study
- Who is it for?
- Ages 13 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder, Depression, Conduct Disorder
- What is being tested?
- TF-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 13 to 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- War-affected children and adolescents
Who cannot join
- No traumatic war events experienced
- Psychosis
- Inability to speak Swahili, French or English
About this study
Official title: Evaluation of a Group-based, Cognitive-behavioural Intervention With Former Child Soldiers and Other War-affected Children in the Democratic Republic of Congo: A Randomised Controlled Trial.
The purpose of this study is to evaluate, in a randomised control trial (RCT), the effectiveness of group-based, trauma-focused Cognitive Behaviour Therapy (TF-CBT) in reducing psychological distress in former child soldiers and other war-affected children in the Democratic Republic of Congo (DRC).
Read the detailed description
To the best of the author's knowledge this is the first group-based mental health or psychosocial intervention developed specifically for psychologically distressed former child soldiers. While CBT is the modality with most empirical evidence for treating war-affected young people, this is the first evaluation with child soldiers specifically.
Former child soldiers and war affected 'street boys' (aged 13-17) in eastern DRC, will be screened for symptoms of psychological distress and then randomly assigned to either a treatment group or a waiting-list control. The treatment groups will receive a 15-session manualised, culturally-adapted, TF-CBT intervention. This includes psycho-education, relaxation, affect modulation, cognitive processing and constructing a trauma narrative. After treatment and post-testing, the waiting-list controls then begin their intervention.
- Conditions
- Post-traumatic Stress Disorder, Depression, Conduct Disorder
- Being tested
- TF-CBT
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TF-CBTBehavioural
Also called Trauma-focused Cognitive Behavioral Therapy
15 sessions of group-based, trauma-focused cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| TF-CBT | Experimental | Not described Receives: Behavioral: TF-CBT |
| Waiting List control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI
Measured: Post-intervention and 3 month
Secondary outcomes (1)
Change in psychosocial distress- measures by African Youth Psychosocial Assessment
Psychosocial distress- depression, anxiety, conduct problems, antisocial behaviour
Measured: Post-intervention and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John McMullen, Queen's University, Belfast
- Investigators
- Harry Dr Rafferty, Study director, Queens University Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494831
- Sponsor's protocol ID
- PREC23
- Status last verified
- Jan 2012
- First submitted
- 15 Dec 2011
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McMullen J, O'Callaghan P, Shannon C, Black A, Eakin J. Group trauma-focused cognitive-behavioural therapy with former child soldiers and other war-affected boys in the DR Congo: a randomised controlled trial. J Child Psychol Psychiatry. 2013 Nov;54(11):1231-41. doi: 10.1111/jcpp.12094. Epub 2013 Jun 6.
PubMed 23738530
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Group-based, Cognitive-behavioural Intervention With Former Child Soldiers and Other War-affected Children in the Democratic Republic of Congo: A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT01494831
- Acronym / sponsor ID
- PREC23
- Conditions
- Post-traumatic Stress Disorder, Depression, Conduct Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate, in a randomised control trial (RCT), the effectiveness of group-based, trauma-focused Cognitive Behaviour Therapy (TF-CBT) in reducing psychological distress in former child soldiers and other war-affected children in the Democratic Republic of Congo (DRC).
Detailed description
To the best of the author's knowledge this is the first group-based mental health or psychosocial intervention developed specifically for psychologically distressed former child soldiers. While CBT is the modality with most empirical evidence for treating war-affected young people, this is the first evaluation with child soldiers specifically.
Former child soldiers and war affected 'street boys' (aged 13-17) in eastern DRC, will be screened for symptoms of psychological distress and then randomly assigned to either a treatment group or a waiting-list control. The treatment groups will receive a 15-session manualised, culturally-adapted, TF-CBT intervention. This includes psycho-education, relaxation, affect modulation, cognitive processing and constructing a trauma narrative. After treatment and post-testing, the waiting-list controls then begin their intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TF-CBT | Experimental | Behavioral: TF-CBT |
| Waiting List control | No intervention | – |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- War-affected children and adolescents
Key exclusion criteria (3 listed)
- No traumatic war events experienced
- Psychosis
- Inability to speak Swahili, French or English
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 |
|---|---|---|
| TF-CBTAlso: Trauma-focused Cognitive Behavioral Therapy15 sessions of group-based, trauma-focused cognitive behavioral therapy | Behavioural | TF-CBT |
Primary outcome
Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI
Time frame: Post-intervention and 3 month
1 secondary outcome
Change in psychosocial distress- measures by African Youth Psychosocial Assessment
Time frame: Post-intervention and 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
- Derived from this study: PubMed 23738530McMullen J, O'Callaghan P, Shannon C, Black A, Eakin J. Group trauma-focused cognitive-behavioural therapy with former child soldiers and other war-affected boys in the DR Congo: a randomised controlled trial. J Child Psychol Psychiatry. 2013 Nov;54(11):1231-41. doi: 10.1111/jcpp.12094. Epub 2013 Jun 6.
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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.
Harry Dr Rafferty study director
Queens University Belfast
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TF-CBT in people with Post-traumatic Stress Disorder and Depression, run by Queen's University, Belfast.
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 1 inclusion and 3 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 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 measured by UCLA-PTSD-RI (time frame: Post-intervention and 3 month). 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 NCT01494831, 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 18 Jan 2012.