Childhood Traumatic GriefNCT01822366
Randomized Controlled Trial of Trauma-focused CBT in Tanzania and Kenya
A study testing Trauma-focused Cognitive Behavioral Therapy in people with Childhood Traumatic Grief and Post Traumatic Stress, run by Duke University at 3 sites in 3 countries.
Trial summary
The primary goal is to study the effectiveness of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in treating traumatic grief and traumatic stress for orphaned children and young adolescents in two East African sites with high prevalence HIV, Moshi, Tanzania (TZ) and Bungoma, Kenya (KE), through a randomized… Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Childhood Traumatic Grief, Post Traumatic Stress, Post Traumatic Stress Disorder
- What is being tested?
- Trauma-focused Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,280 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Aug 2012to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 7-13 living in Moshi, Tanzania or Bungoma, Kenya who have had one or both parents die since they were 3 years old or older.
- Children must have scores on study measures indicating they have symptoms of traumatic grief and/or traumatic stress.
- Children must be living with an adult guardian who is willing to participate in 12 weekly group sessions.
- Adult guardians of eligible children.
Who cannot join
- Living in an institution (not with a guardian).
- Parent(s) died before child was 3 years old.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
University of Washington Department of Psychology
Seattle, Washington, 98195
About this study
Official title: Improving Health Outcomes by Preventing HIV/STD Risk
The primary goal is to study the effectiveness of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in treating traumatic grief and traumatic stress for orphaned children and young adolescents in two East African sites with high prevalence HIV, Moshi, Tanzania (TZ) and Bungoma, Kenya (KE), through a randomized controlled trial (RCT). In a previous feasibility study of TF-CBT with orphans in Tanzania, the investigators have found a group-based TF-CBT intervention to be feasible and acceptable, with promising clinical outcomes. In the feasibility study, lay counselors with no prior mental health experience delivered the intervention with training and supervision by our team of mental health and TF-CBT experts.
Building on this initial study, the investigators are conducting a RCT to test the effectiveness of TF-CBT for traumatic grief and traumatic stress compared to receipt of usual care orphan services in TZ and KE. The study involves collaboration with HIV/AIDS grassroots organizations and local Co-Investigators in TZ and KE, both of whom are longstanding collaborators with the investigators' US team and are located in mixed urban and rural areas, allowing examination of effectiveness in two countries and two settings (urban/rural). Using a task-shifting approach, in which lay individuals are trained as counselors, the investigators will train six counselors in each country, who deliver 20 groups in each site (8 rural, 12 urban), resulting in 320 children and adolescents (ages 7-13) who receive TF-CBT and 320 who receive usual care. Outcomes for children are assessed at 12-14 weeks (i.e., corresponding with the end of TF-CBT), 6-months post-treatment, and 12-months post-treatment. TF-CBT experts from the investigators' team partner with the lay counselors from the feasibility study (e.g., local trainers) to train the TZ and KE counselors, and these local trainers provide the TF-CBT supervision, while supervised themselves by the US-based TF-CBT and mental health experts. The investigators expect this trial to yield recommendations regarding an effective intervention for orphans that is acceptable, feasible, and includes local responsibility as a means to enhance potential sustainability in Low- and Middle-Income Countries (LMICs). Findings will inform other efforts to scale up mental health interventions to address the substantial mental health gap.
- Conditions
- Childhood Traumatic Grief, Post Traumatic Stress, Post Traumatic Stress Disorder, Depressive Symptoms, Behavioral Problems, Child Overall Daily Functioning
- Being tested
- Trauma-focused Cognitive Behavioral Therapy
- Keywords
- Children, Adolescents, Trauma-focused Cognitive Behavioral Therapy (TF-CBT), Low- and Middle-Income Countries (LMIC), Randomized Controlled Trial (RCT), Evidence-Based Practice (EBP), Childhood Traumatic Grief (CTG), Post-Traumatic Stress Disorder (PTSD), Kenya, Tanzania, East Africa, Mental Health
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Problem Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-focused Cognitive Behavioral TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Comparison Condition | No intervention | Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control. |
| Trauma-focused CBT group therapy | Experimental | Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment. Receives: Behavioral: Trauma-focused Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Syndrome (PTSS)
Measured using the Child PTSD Symptoms Scale (CPSS). Caregiver and Child reported separately. Scale range 0-57, with 57 representing extremely high PTSS symptomatology (worse outcome). 634 children and 634 caregivers (1268 total) analyzed at baseline and 3-month follow-up--includes all 1280 enrolled at baseline, minus 12 lost to follow-up.
Measured: Baseline, 3 months
Childhood Traumatic Grief
Measured using the Inventory of Complicated Grief (ICG). Child report only. Scale range 0-112, with 112 representing extremely high grief symptomatology (worse outcome). 634 children and 634 caregivers (1268 total) analyzed at baseline and 3-month follow-up--includes all 1280 enrolled at baseline, minus 12 lost to follow-up.
Measured: Baseline, 3 months
Secondary outcomes (1)
Behavioral Difficulties
Child report: Measured using the combined mean score of 1) the broadband externalizing scale of the Youth Self-Report (YSR) and 2) behavior-related items developed locally that are culturally specific. All items included are measured on a scale of 0-2, with 0 representing no behavioral difficulties (better) and 2 representing frequent behavioral difficulties (worse).
Caregiver report: Measured using the combined mean score of 1) the broadband externalizing scale of the Child Behavior Checklist (CBCL) and 2) behavior-related items developed locally that are culturally specific. All items included are measured on a scale of 0-2, with 0 representing no behavioral difficulties (better) and 2 representing frequent behavioral difficulties (worse).
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startAug 2012
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood Traumatic GriefStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Tanzania Women Research Foundation (TAWREF), Ace Africa, University of Washington
- Responsible party
- Sponsor
- Investigators
- Shannon Dorsey, PhD, Principal investigator, University of WashingtonKate Whetten, PhD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822366
- Sponsor's protocol ID
- Pro00039770
- Other IDs
- R01MH096633
- Status last verified
- Apr 2021
- First submitted
- 25 Mar 2013
- Last updated
- 5 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dorsey S, Lucid L, Martin P, King KM, O'Donnell K, Murray LK, Wasonga AI, Itemba DK, Cohen JA, Manongi R, Whetten K. Effectiveness of Task-Shifted Trauma-Focused Cognitive Behavioral Therapy for Children Who Experienced Parental Death and Posttraumatic Stress in Kenya and Tanzania: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):464-473. doi: 10.1001/jamapsychiatry.2019.4475.
PubMed 31968059
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Outcomes by Preventing HIV/STD Risk
- ClinicalTrials.gov ID
- NCT01822366
- Acronym / sponsor ID
- Pro00039770
- Conditions
- Childhood Traumatic Grief, Post Traumatic Stress, Post Traumatic Stress Disorder, Depressive Symptoms, Behavioral Problems, Child Overall Daily Functioning
- Keywords
- Children, Adolescents, Trauma-focused Cognitive Behavioral Therapy (TF-CBT), Low- and Middle-Income Countries (LMIC), Randomized Controlled Trial (RCT), Evidence-Based Practice (EBP), Childhood Traumatic Grief (CTG), Post-Traumatic Stress Disorder (PTSD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,280 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Tanzania Women Research Foundation (TAWREF), Ace Africa, University of Washington
- Study start
- Aug 2012 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Posted 23 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal is to study the effectiveness of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in treating traumatic grief and traumatic stress for orphaned children and young adolescents in two East African sites with high prevalence HIV, Moshi, Tanzania (TZ) and Bungoma, Kenya (KE), through a randomized controlled trial (RCT). In a previous feasibility study of TF-CBT with orphans in Tanzania, the investigators have found a group-based TF-CBT intervention to be feasible and acceptable, with promising clinical outcomes. In the feasibility study, lay counselors with no prior mental health experience delivered the intervention with training and supervision by our team of mental health and TF-CBT experts.
Building on this initial study, the investigators are conducting a RCT to test the effectiveness of TF-CBT for traumatic grief and traumatic stress compared to receipt of usual care orphan services in TZ and KE. The study involves collaboration with HIV/AIDS grassroots organizations and local Co-Investigators in TZ and KE, both of whom are longstanding collaborators with the investigators' US team and are located in mixed urban and rural areas, allowing examination of effectiveness in two countries and two settings (urban/rural). Using a task-shifting approach, in which lay individuals are trained as counselors, the investigators will train six counselors in each country, who deliver 20 groups in each site (8 rural, 12 urban), resulting in 320 children and adolescents (ages 7-13) who receive TF-CBT and 320 who receive usual care. Outcomes for children are assessed at 12-14 weeks (i.e., corresponding with the end of TF-CBT), 6-months post-treatment, and 12-months post-treatment. TF-CBT experts from the investigators' team partner with the lay counselors from the feasibility study (e.g., local trainers) to train the TZ and KE counselors, and these local trainers provide the TF-CBT supervision, while supervised themselves by the US-based TF-CBT and mental health experts. The investigators expect this trial to yield recommendations regarding an effective intervention for orphans that is acceptable, feasible, and includes local responsibility as a means to enhance potential sustainability in Low- and Middle-Income Countries (LMICs). Findings will inform other efforts to scale up mental health interventions to address the substantial mental health gap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Comparison Condition | No intervention | –Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control. |
| Trauma-focused CBT group therapy | Experimental | Behavioral: Trauma-focused Cognitive Behavioral TherapyHalf of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children ages 7-13 living in Moshi, Tanzania or Bungoma, Kenya who have had one or both parents die since they were 3 years old or older.
- Children must have scores on study measures indicating they have symptoms of traumatic grief and/or traumatic stress.
- Children must be living with an adult guardian who is willing to participate in 12 weekly group sessions.
- Adult guardians of eligible children.
Key exclusion criteria (2 listed)
- Living in an institution (not with a guardian).
- Parent(s) died before child was 3 years old.
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 |
|---|---|---|
| Trauma-focused Cognitive Behavioral Therapy | Behavioural | Trauma-focused CBT group therapy |
Primary outcome
Posttraumatic Stress Syndrome (PTSS)
Time frame: Baseline, 3 months
Measured using the Child PTSD Symptoms Scale (CPSS). Caregiver and Child reported separately. Scale range 0-57, with 57 representing extremely high PTSS symptomatology (worse outcome). 634 children and 634 caregivers (1268 total) analyzed at baseline and 3-month follow-up--includes all 1280 enrolled at baseline, minus 12 lost to follow-up.
Childhood Traumatic Grief
Time frame: Baseline, 3 months
Measured using the Inventory of Complicated Grief (ICG). Child report only. Scale range 0-112, with 112 representing extremely high grief symptomatology (worse outcome). 634 children and 634 caregivers (1268 total) analyzed at baseline and 3-month follow-up--includes all 1280 enrolled at baseline, minus 12 lost to follow-up.
1 secondary outcome
Behavioral Difficulties
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31968059Dorsey S, Lucid L, Martin P, King KM, O'Donnell K, Murray LK, Wasonga AI, Itemba DK, Cohen JA, Manongi R, Whetten K. Effectiveness of Task-Shifted Trauma-Focused Cognitive Behavioral Therapy for Children Who Experienced Parental Death and Posttraumatic Stress in Kenya and Tanzania: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):464-473. doi: 10.1001/jamapsychiatry.2019.4475.
- Pamoja Tunaweza (Together We Can)Link provided by the sponsor.
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.
Shannon Dorsey, PhD principal investigator
University of Washington
Kate Whetten, PhD, MPH principal investigator
Duke University
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-focused Cognitive Behavioral Therapy in people with Childhood Traumatic Grief and Post Traumatic Stress, run by Duke University at 3 sites in 3 countries.
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 4 inclusion and 2 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 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Kenya, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 23 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Posttraumatic Stress Syndrome (PTSS) (time frame: Baseline, 3 months). 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 NCT01822366, 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 5 May 2021.