NCT02368808

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
843

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

10 months

First QC Date

February 9, 2015

Last Update Submit

March 10, 2017

Conditions

Keywords

orphans and vulnerable childrenSouth Africapeer support group

Outcome Measures

Primary Outcomes (2)

  • Change in Grief Intensity

    Grief intensity, including general grief, intrusive thoughts and prolonged grief, is assessed through adolescent self-report of items from three standardized scales (1) Core Bereavement Items (CBI) five-item grief subscale (Burnett et al, 1997); (2) Intrusive Grief Thoughts Scale (IGTS) (ASU Program for Prevention Research, 1999); and the (3) Inventory of Complicated Grief -Revised for Children (ICG-RC) six-item screening tool (Melhem, Porta, Payne \& Brent, 2013).

    Baseline, 2 months post-intervention

  • Change in Mental Health

    Depressive symptomology will be assessed through adolescent self-report of the 20-item Center for Epidemiologic Studies Depression Scale for Children (CES-DC) (Weissman 1980, Faulstich 1986). Items assess the frequency of symptoms of depression including feelings of happiness, appetite, self-esteem, energy levels, sleep patterns, etc. Adolescent behaviour is assessed using the Brief Problem Monitor-Parent Form (BPM-P) (Achenbach 2011). BPM-P is a 19-item subset of the Child Behavior Checklist (CBCL) that captures problem behaviour, including internalizing and externalizing behaviour in children ages 6-18. Caregivers report on adolescent behaviour over the past four weeks.

    Baseline, 2 months post-intervention

Secondary Outcomes (4)

  • Change in Caregiver-Adolescent Interactions

    Baseline, 2 months post-intervention

  • Change in Social Support

    Baseline, 2 months post-intervention

  • Change in Academic Competence

    Baseline, 2 months post-intervention

  • Change in Resilience

    Baseline, 2 months post-intervention

Study Arms (2)

Abangane Support Group

EXPERIMENTAL

Bereavement support group for adolescents

Behavioral: Abangane Support Group

Wait List

NO INTERVENTION

Wait-listed adolescents will be able to participate in Abangane at the close of the study.

Interventions

The Abangane support group program consists of 8 sessions for bereaved adolescents with standardized activities and discussion content based the Khululeka Grief Support Program in Cape Town, South Africa. The materials include a resource book that provides training and referral agencies for grief group facilitators as well as exercises and creative activities designed to stimulate group discussions that will help adolescents to deal with loss and grief.

Abangane Support Group

Eligibility Criteria

Age13 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Previous participation in CWBFN\&CLFS grief counselling group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Officials

  • Tonya R Thurman, MPH, PhD

    Tulane University School of Social Work

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 23, 2015

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 13, 2017

Record last verified: 2017-03