Psychological and Psychosocial Intervention With War-Affected Children

NCT ID: NCT01509872

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-04-30

Brief 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 problems and increasing pro-social behavior among war-affected children in the Democratic Republic of Congo.

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety; Conduct; Pro-social Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Trauma-Focused Cognitive Behavioral Therapy

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.

Group Type: EXPERIMENTAL

Trauma Focused Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy

A Child Friendly Space

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.

Group Type: ACTIVE_COMPARATOR

Child Friendly Space

Intervention Type: BEHAVIORAL

9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention

Interventions

Trauma Focused Cognitive Behavioral Therapy

9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy

Intervention Type: BEHAVIORAL

Child Friendly Space

9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• psychosis,
• mental retardation,
• inability to understand Swahili,
• severe emotional & behavioral problems that made group participation impossible

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Transcultural Psychosocial Organization Nepal

OTHER

Sponsor Role: collaborator

UNICEF

OTHER

Sponsor Role: collaborator

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

Paul O'Callaghan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Ciarán Shannon, BA, MA, DClin

Role: STUDY_DIRECTOR

British Psychological Society (Chartered Clinical Psychologist)

Locations

Child Friendly Space

Mwenga, South Kivu, Republic of the Congo

Countries

Republic of the Congo

Other Identifiers

PREC73-2011

Identifier Type: -

Identifier Source: org_study_id