GriefNCT02368808
Adolescent Bereavement Initiative in the Free State, South Africa
A study testing Abangane Support Group in people with Grief and Bereavement, run by Tulane University School of Social Work.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years, women only
- Conditions the study is for
- Grief, Bereavement
- What is being tested?
- Abangane Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 843 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Nov 2015
- Phase
- Interventional
- 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 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Attends one of the participating schools
- English or Sesotho speaker
Who cannot join
- Previous participation in CWBFN\&CLFS grief counselling group
About this study
Official title: Coping With Loss: A Bereavement Initiative for Adolescent Girls in the Free State, South Africa
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.
Read the 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)
- Conditions
- Grief, Bereavement
- Being tested
- Abangane Support Group
- Keywords
- orphans and vulnerable children, South Africa, peer support group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abangane Support GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Abangane Support Group | Experimental | Bereavement support group for adolescents Receives: Behavioral: Abangane Support Group |
| Wait List | No intervention | Wait-listed adolescents will be able to participate in Abangane at the close of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline, 2 months post-intervention
Secondary outcomes (4)
Change in Caregiver-Adolescent Interactions
Caregiver-Adolescent interactions are assessed through adolescent report of connectedness to caregiver and caregiver report of positive parenting practices, such as discipline, supervision, and supportiveness. Connectedness to Caregiver is assessed using the Inventory of Parent and Peer Attachment (Amsden \& Greenberg, 1987). Positive parenting, discipline and supervision were measured using the Alabama Parenting Questionnaire short form (APQ-9) (Elgar et al). Harsh punishment is assessed through both caregiver and adolescent report using an adapted version of the Parent-Child Conflict Tactics Scale (CTSPC)'s psychological aggression and physical assault subscales (Straus et al., 1998). Supportiveness was measured with The Parent Behavior Inventory (PBI)'s Supportive/Engaged subscale, which measures parental affect towards the adolescent in their care (Lovejoy, Weis, O'hare \& Rubin, 1999).
Measured: Baseline, 2 months post-intervention
Change in Social Support
Social Support is assessed through items focused on social support received in dealing with the bereavement itself, basic social support, and emotional social support. Social support for coping with bereavement was measured using self-generated items, such as You can discuss your feelings about this loss with your family. Emotional social support is measured with the giving and receiving emotional support subscales of the 2-Way Social Support Scale (Shakespeare-Finch \& Obst, 2011). Basic social support consists of four items from the MEASURE evaluation (Measure Evaluation, 2014).
Measured: Baseline, 2 months post-intervention
Change in Academic Competence
Academic competence is assessed through adolescent self-report of academic self-efficacy, motivation and attendance. Academic self-efficacy is based on the academic self-efficacy subscale of the Self-Efficacy Questionnaire for Children (SEQ-C) (Muris, 2001) and assesses perceived performance in school including success in paying attention, passing tests, and completing homework. Academic motivation assesses the perceived importance of education and efforts to do well in school. Attendance is measured with one self-generated item which asks about absenteeism in the seven days prior to the survey, not including school holidays.
Measured: Baseline, 2 months post-intervention
Change in Resilience
Resilience is assessed through positive appraisal coping abilities, including perceived coping, personal growth, emotional regulation and future expectations. Perceived coping is assessed with a self-generated scale based on items from the Grief Evaluation Measure (GEM) (Jordan \& Baker, 2005). Personal growth as a result of the loss is assessed using the personal growth subscale of the Hogan Grief Reaction Checklist (Hogan, Greenfield \& Schmidt, 2001). Emotional regulation is based on the adolescent's emotional self-efficacy, or perceived ability to regulate feelings and emotions, and is assessed with the emotional self-efficacy subscale of the Self-Efficacy Questionnaire for Children (SEQ-C) (Muris, 2001). Future expectations, or hopes for the future, is based on items from a self-generated scale used in a previous study of OVC in South Africa by the authors (Thurman, 2011) and an adapted subscale of the Social and Health Assessment (SAHA) (Ruchkin 2004).
Measured: Baseline, 2 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2015
- Study completionNov 2015
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 GriefStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University School of Social Work
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Principal investigator, Tonya Renee Thurman, Tulane University School of Social Work
- Investigators
- Tonya R Thurman, MPH, PhD, Principal investigator, Tulane University School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368808
- Sponsor's protocol ID
- AID-674-A-12-00002-CWL
- Status last verified
- Mar 2017
- First submitted
- 9 Feb 2015
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28462880
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping With Loss: A Bereavement Initiative for Adolescent Girls in the Free State, South Africa
- ClinicalTrials.gov ID
- NCT02368808
- Acronym / sponsor ID
- AID-674-A-12-00002-CWL
- Conditions
- Grief, Bereavement
- Keywords
- orphans and vulnerable children, South Africa, peer support group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- Tulane University School of Social WorkUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Feb 2015 (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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abangane Support Group | Experimental | Behavioral: Abangane Support GroupBereavement support group for adolescents |
| Wait List | No intervention | –Wait-listed adolescents will be able to participate in Abangane at the close of the study. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Attends one of the participating schools
- English or Sesotho speaker
Key exclusion criteria (1 listed)
- Previous participation in CWBFN\&CLFS grief counselling group
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 |
|---|---|---|
| Abangane Support GroupThe 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. | Behavioural | Abangane Support Group |
Primary outcome
Change in Grief Intensity
Time frame: Baseline, 2 months post-intervention
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).
Change in Mental Health
Time frame: Baseline, 2 months post-intervention
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.
4 secondary outcomes
Change in Caregiver-Adolescent Interactions
Time frame: Baseline, 2 months post-intervention
Change in Social Support
Time frame: Baseline, 2 months post-intervention
Change in Academic Competence
Time frame: Baseline, 2 months post-intervention
Change in Resilience
Time frame: Baseline, 2 months post-intervention
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 13 Mar 2017.
- Derived from this study: PubMed 28462880Thurman 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.
- Individual participant dataSharing planned: Undecided
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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.
Tonya R Thurman, MPH, PhD principal investigator
Tulane University School of Social Work
Questions about this trial
What is this clinical trial studying?
A study testing Abangane Support Group in people with Grief and Bereavement, run by Tulane University School of Social Work.
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 2 inclusion and 1 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 13 Mar 2017. 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.
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 Grief Intensity (time frame: Baseline, 2 months post-intervention). The study lists 2 primary outcomes in all. 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 NCT02368808, 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 13 Mar 2017.