Clinical trial NCT02368808: Adolescent Bereavement Initiative in the Free State, South Africa
Official title: Coping With Loss: A Bereavement Initiative for Adolescent Girls in the Free State, South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grief
Bereavement
Keywords: orphans and vulnerable children
South Africa
peer support group
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2015-02-23
Enrollment: 843
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coping with Loss is a randomized controlled trial to assess the effectiveness of a bereavement intervention targeting female adolescents who have experienced the death of someone important in their lives. Adolescents aged 12 and older in the Free State province of South Africa will be invited to participate in an 8-session school-based peer support group focused on coping with loss. Interventions will be implemented by Social Workers from Child Welfare Bloemfontein and Childline Free State (CWBFN \& CLFS) that have provided support services for orphans and vulnerable children (OVC) in the Free State Province since 2013. The study population will be identified through the CWBFN \& CLFS intake process and consist of bereaved female adolescents from up to 11 participating schools. Eligible adolescents will be randomly assigned to receive the intervention in 2015 or wait-listed for enrollment following the study period. Survey data will be collected from adolescents and caregivers before and two months following the completion of the interventions. Data will be analyzed to assess for pre- and post-test differences between the intervention and wait-listed group on key psychosocial outcomes, including measures of grief, resilience, mental health, social support, academic competence and adolescent-caregiver interactions.

Detailed description: The HIV/AIDS epidemic, accidental injuries and violence have gradually increased the mortality rate among prime age adults in South Africa since 1997 (Statistics South Africa, 2006) leading to an increase in the number of children experiencing bereavement. Of the approximately four million orphans in South Africa in 2012, over half (62.5%) are due to parental death from AIDS (UNICEF, 2013). Studies have found that parental loss in childhood and adolescence is associated with a range of immediate and later life outcomes including problems at school, depression, criminality, early sexual activity, and unemployment (Aynsley-Green, 2012). However, support counselling for bereaved children and adolescents is virtually nonexistent in South Africa (Collingwood, 2014) and children are often not encouraged to express grief or participate in mourning rituals for the deceased. A randomized controlled trial of AIDS orphans in Uganda found that school-based peer support groups reduced the symptoms of anxiety, depression and anger compared to a control group that did not participate in the peer support groups (Kumakech, 2009). This base of evidence demonstrates both the unmet need and potential impact of a bereavement initiative that will be offered by CWBFN \& CLFS in Free State. This research will contribute to the evidence base for effective programming for bereaved adolescents in South Africa as well as other high HIV prevalence populations.

The aim of this study is to assess the effectiveness of time-limited adolescent grief counseling peer groups in improving the psychosocial wellbeing of bereaved female adolescents. Results from the study will be used to develop evidence-based youth bereavement counselling programs to be implemented in additional areas of South Africa. The results will be presented to South African OVC social service organizations as well as submitted to peer-reviewed scientific journals for wider dissemination.

(Note that the original study design included a family component/sessions for caregivers that was not able to be realized by the program implementers)

Eligibility criteria: Inclusion Criteria:

* Attends one of the participating schools
* English or Sesotho speaker

Exclusion Criteria:

* Previous participation in CWBFN\&CLFS grief counselling group

Primary outcomes:
measure: Change in Grief Intensity
timeFrame: Baseline, 2 months post-intervention
measure: Change in Mental Health
timeFrame: Baseline, 2 months post-intervention
Secondary outcomes:
measure: Change in Caregiver-Adolescent Interactions
timeFrame: Baseline, 2 months post-intervention
measure: Change in Social Support
timeFrame: Baseline, 2 months post-intervention
measure: Change in Academic Competence
timeFrame: Baseline, 2 months post-intervention
measure: Change in Resilience
timeFrame: Baseline, 2 months post-intervention
Other outcomes:
Locations:
Study officials:
affiliation: Tulane University School of Social Work
name: Tonya R Thurman, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thurman TR, Luckett BG, Nice J, Spyrelis A, Taylor TM. Effect of a bereavement support group on female adolescents' psychological health: a randomised controlled trial in South Africa. Lancet Glob Health. 2017 Jun;5(6):e604-e614. doi: 10.1016/S2214-109X(17)30146-8. Epub 2017 Apr 24.