- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01494831
Randomized Control Trial of Group Intervention With Former War-affected Boys in the Democratic Republic of Congo
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- War-affected children and adolescents
Exclusion Criteria:
- No traumatic war events experienced
- Psychosis
- Inability to speak Swahili, French or English
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: TF-CBT
|
15 sessions of group-based, trauma-focused cognitive behavioral therapy
Andre navne:
|
|
Ingen indgriben: Waiting List control
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI
Tidsramme: Post-intervention and 3 month
|
Post-intervention and 3 month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in psychosocial distress- measures by African Youth Psychosocial Assessment
Tidsramme: Post-intervention and 3 month
|
Psychosocial distress- depression, anxiety, conduct problems, antisocial behaviour
|
Post-intervention and 3 month
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Harry Dr Rafferty, Queens University Belfast
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PREC23
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