Bereavement Clinical Trial
Official title:
Coping With Loss: A Bereavement Initiative for Adolescent Girls in the Free State, South Africa
Verified date | March 2017 |
Source | Tulane University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 843 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 13 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Attends one of the participating schools - English or Sesotho speaker Exclusion Criteria: - Previous participation in CWBFN&CLFS grief counselling group |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tulane University School of Social Work | United States Agency for International Development (USAID) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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). | Baseline, 2 months post-intervention | |
Secondary | 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). | Baseline, 2 months post-intervention | |
Secondary | 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. | Baseline, 2 months post-intervention | |
Secondary | 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). | Baseline, 2 months post-intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00194844 -
Couples Miscarriage Healing Project:Randomized Trial
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT03286647 -
Oral Hygiene Self-efficacy in Patients With Grief
|
N/A | |
Recruiting |
NCT05587517 -
A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients
|
Phase 2 | |
Recruiting |
NCT06102096 -
Culturally Adapted iCBT for Arabic-speaking Refugee and Migrant Youth With Common Mental Health Problems
|
N/A | |
Completed |
NCT03330145 -
Complicated Grief Among Children After a Death From Cancer or Another Cause: A Longitudinal and Prospective Study (CAPS)
|
N/A | |
Completed |
NCT02631291 -
Promoting Widowed Elders Lifestyle After Loss
|
N/A | |
Completed |
NCT04600076 -
MOMSonLINE2 ; A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers
|
N/A | |
Recruiting |
NCT05624879 -
Accelerated Resolution Therapy for Early Maladaptive Grief
|
N/A | |
Recruiting |
NCT04656977 -
Providing Psychological and Emotional Support After Perinatal Loss: A Virtual Reality-Based Intervention
|
N/A | |
Completed |
NCT04376385 -
An Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)
|
N/A | |
Completed |
NCT05156346 -
Pragmatic RCT to Assess the Effectiveness of an Online Self-help Programme for Older Adults After Spousal Bereavement
|
N/A | |
Completed |
NCT01433653 -
Cognitive Behavioral Therapy for Complicated Grief
|
N/A | |
Recruiting |
NCT06047808 -
Feasibility Study of the Storytelling Through Music Intervention With Bereaved Parents
|
N/A | |
Recruiting |
NCT05142605 -
Evaluation of Grief Therapy Approaches for Bereaved Parents
|
N/A | |
Completed |
NCT03177772 -
Group Therapy For Dementia Caregivers At Risk For Complicated Grief
|
||
Completed |
NCT01384942 -
Meaning-based Group Counselling for Bereavement
|
Phase 2 | |
Completed |
NCT01292512 -
Bereavement Management - Description, Assessment and Care
|
N/A | |
Recruiting |
NCT04883151 -
A Psychological Intervention for Families in Pediatric Palliative Care
|
N/A | |
Active, not recruiting |
NCT05930912 -
Psychiatric Orders in Psychoanalytic Treatment of ASD
|
||
Completed |
NCT02838290 -
Occupational Distress in Doctors: The Effect of an Induction Programme
|
N/A |