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GriefBASICNCT03243396

Building and Sustaining Interventions for Children: Task-sharing Mental Health Care in Low-resource Settings

A study testing Trauma-Focused Cognitive Behavioral Therapy in people with Grief and Post Traumatic Stress Disorder, run by Duke University at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The BASIC study will take place in Kanduyi/Bungoma South Sub-County, in western Kenya, and focuses on children orphaned by one or two parents. Growing evidence demonstrates that orphaned children in low- and middle-income countries are at higher risk of mental health problems, but mental health professionals are… Read more about this study

Who is it for?
Ages 11 to 14 years
Conditions the study is for
Grief, Post Traumatic Stress Disorder, Depression
What is being tested?
Trauma-Focused Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
956 participants
Where
1 siteKenya
Study dates
1 Feb 2018to 25 Jan 2024
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 11 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Child or young adolescent between the ages of 11 and 14 at the time of enrollment
  • Child lost one or both parents to death at least 6 months ago or later, and when the child was 4 years old or older
  • Child lives in the community with at least one adult guardian (18 years old or older)
  • Child is experiencing borderline or clinically significant levels of post-traumatic stress or childhood traumatic grief (as indicated by a score of 18 or higher on the Child Posttraumatic Stress Scale, or a score of 35 or higher on the Inventory of Complicated Grief)

Who cannot join

  • Child has a known developmental or cognitive disability
  • Child attends private school
  • Child and family are about to move
  • Children who lost a parent less than 6 months ago (since they may be experiencing a normal grief reaction and may not necessarily be in need of the treatment for CTG)
  • Caregiver of the child refuses to participate
  • Lay counselor is not literate
Show all 9Show fewer
  • Lay counselor does not have a mobile phone
  • Lay counselor refuses to serve as a counselor
  • Site leader refuses to allow their site to participate in the study

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • ACE Africa

    Bungoma, Bungoma County

Other trials in Kenya

About this study

Official title: Building and Sustaining Interventions for Children (BASIC): Task-sharing Mental Health Care in Low-resource Settings

The BASIC study will take place in Kanduyi/Bungoma South Sub-County, in western Kenya, and focuses on children orphaned by one or two parents. Growing evidence demonstrates that orphaned children in low- and middle-income countries are at higher risk of mental health problems, but mental health professionals are largely unavailable in this area. Research suggests that some mental health treatments can be delivered effectively in low- and middle-income countries using a task-shifting approach, in which lay counselors with little or no prior mental health experience are trained to provide treatment, and deliver with supervision. However, very little is known about how to support local systems and organizations in delivering mental health care via task-shifting, particularly in a way that could scale-able and sustainable in the low-resource context. The BASIC team's prior work suggests that partnering with two government sectors, education and health, could be a low-cost and sustainable strategy to implement task-shifted mental health services. By training teachers (via the Education sector) and community health volunteers (via the Health sector) to provide mental health care, a larger population could potentially be reached. Before attempting any country or system-wide implementation, it is important to know what is needed to enable successful implementation in either or both sectors, client outcomes for those receiving mental health care when delivered via Education or Health, and cost of delivery in both sectors. The team aims to collect outcomes that are relevant to policy makers, and that can be considered along with cost and experiences in both sectors.

Read the detailed description

Building and Sustaining Interventions for Children (BASIC): Task-sharing mental health care in low-resource settings builds on our 15-year history of collaborations with research partners in Kenya, prior NIH-funded work that identified mental health needs of orphaned children in low- and middle-income countries, and iterative and collaborative intervention adaptation and testing using a task-sharing approach, to address these needs.Our goal is to identify locally sustainable implementation policies and practices (IPPs) that lead to effective implementation of task-shared evidence-based treatment (EBT) delivery (a locally adapted version of Trauma-focused Cognitive Behavioral Therapy (TF-CBT), Pamoja Tunaweza in this study) in 2 governmental sectors in Kenya. Both sectors were identified by our Kenyan partners as potential platforms for scale- up-Education via teacher delivery and Health via community health volunteer (CHV) delivery. Both Education and Health may be viable sectors for mental health care delivery, but the IPPs that predict implementation success and intervention effectiveness in either/ both sectors are unknown. This study identifies con-textually relevant, practical, and actionable IPPs that can inform implementation planning, while also assessing child outcomes and intervention costs in both sectors.

The recent devolvement of the Kenyan government (leading to more local decision-making), the launch of a National Mental Health Policy, and our Kenyan partners' empowerment work building enthusiasm for TF-CBT are converging to create a local climate in which BASIC could become part of the county plan, if evidence-based guidance for implementation, using mostly existing resources, existed. The trial design is an incomplete stepped wedge cluster randomized controlled trial (SW-CRT) including 40 schools and the 40 surrounding villages. The school and the surrounding community are considered a "village cluster." Each of the 40 "village clusters" has 1 team of teachers and 1 team of CHVs delivering Pamoja Tunaweza, resulting in 120 trained lay counselors in each sector, who provide TF-CBT to 1,280 youth and one of their guardians, across seven sequences of the SW-CRT. Site leaders are enrolled for data collection (up to 80), but do not provide services. The study uses a novel method, qualitative comparative analyses (QCA), that holds potential for substantially advancing the field of implementation science. QCA leverages the rigor of quantitative approaches and the detail of qualitative approaches, and allows for complex causality and equifinality (i.e., an outcome can be reached by multiple means).

Study aims are: 1) Identify actionable IPPs that predict adoption (delivery) and fidelity (high- quality delivery) after 10 sites in each sector implement TF-CBT (sequence 1). Use identified IPPs to (Aim 1a) guide implementation planning support for subsequent sites and to (Aim 1b) generate testable hypotheses about IPPs as causal mechanisms; 2) Test mechanisms of implementation success in both sectors across all 7 sequences; and 3) Test TF-CBT effectiveness (i.e., mental health outcomes; functioning) and cost in both sectors. This research has important implications for implementing an evidence-based treatment in low-resource settings, including the US.

Being tested
Trauma-Focused Cognitive Behavioral Therapy
Keywords
Mental health, Cognitive behavioral therapy, Task-shifting, Global health, Teacher, Community health volunteer, Children, Orphans, Abandoned children, TF-CBT, Mental health policy, Ministry of Education, Ministry of Health, Delivery, Implementation science, Qualitative comparative analysis, Implementation practices and policies, Youth, Adoption, Fidelity
Medical subject headings
Stress Disorders, Post-Traumatic, Depression, Psychological Well-Being, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trauma-Focused Cognitive Behavioral TherapyBehavioural

    Also called Pamoja Tunaweza

    Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).

Study groups in NCT03243396
Study groupRoleWhat they receive
Health-Sector Delivered CBTExperimentalThese child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers.
Receives: Behavioral: Trauma-Focused Cognitive Behavioral Therapy
Education-Sector Delivered CBTExperimentalThese child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school.
Receives: Behavioral: Trauma-Focused Cognitive Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Posttraumatic Stress Symptoms (Child Report)

    Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (child report), including additional items validated locally. Higher scores represent more severe symptoms. The range of scores is 0 to 66. Scores are the sum of 22 items asking about how often specific things have bothered someone in the past 4 weeks. Each item is measured on a scale of 0 to 3, where 0=never happens and 3=almost always.

    Measured: Baseline, End of 8-session Treatment (assessed up to 18 weeks)

  2. Fidelity

    Ability of the group leader to adhere to established Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) protocols and guidelines, as assessed by the Fidelity and Adherence Rating Scales developed by the study team. Assessed in each observed TF-CBT session by supervisors. Higher scores represent higher adherence to TF-CBT. Adherence is measured on a scale of 0 to 6. Scores reported are observations of Child groups.

    Measured: End of first year of site implementation (2 groups, 8 sessions each)

  3. Number of Sites That Adopted the Intervention

    Adoption is a binary yes/no outcome defined as initiating and delivering the 8-session TF-CBT groups by a 3-counselor team and is measured by counselor self-report (and confirmed by supervisors who observed groups). Assessed for each "trimester" end for schools and communities, summarized over the year. We report the number of sites out of 40 total that adopted the intervention.

    Measured: End of first year of site implementation (2 groups, 8 sessions each)

  4. Number of Sites That Sustained the Intervention

    Sustainment is a binary yes/no outcome defined as maintained delivery 2 years after the study intervention period (2 groups delivered within a calendar year, with at least 80% capacity as compared to their group enrollment during initial implementation). It is measured by counselor self-report (and confirmed by supervisors). At times the number of youth that would be 80% enrolled required rounding down to the nearest whole person. We report the number of sites out of 40 total that sustained the intervention.

    Measured: Two years after the first TF-CBT groups for each site

Secondary outcomes (11)

  1. Change in Posttraumatic Stress Symptoms (Caregiver Report)

    Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (caregiver report), including additional items validated locally. Higher scores represent more severe symptoms. The range of scores is 0 to 66. Scores are the sum of 22 items asking about how often specific things have bothered someone in the past 4 weeks. Each item is measured on a scale of 0 to 3, where 0=never happens and 3=almost always.

    Measured: Baseline, End of 8-session Treatment (assessed up to 18 weeks)

  2. Change in Depressive Symptoms (Child Report)

    Level of experienced depressive symptoms, as assessed by the Adolescent version of the Patient Health Questionnaire (8-question version) and additional items validated locally. Higher scores represent more severe symptoms. The range of scores is 0 to 36. Scores are the sum of 12 item asking how often items have bothered someone in the past 2 weeks. Each item is measured on a scale of 0 to 3, where 0=not at all happens and 3=nearly every day.

    Measured: Baseline, End of 8-session Treatment (assessed up to 18 weeks)

  3. Change in Grief (Child Report)

    Level of grief related to a traumatic event experienced by the child, as assessed by the Inventory of Complex Grief. Higher scores represent more severe symptoms. The range of scores is 0 to 112. Scores are the sum of 28 items asking about how often they have experienced each item past month. Each item is measured on a scale of 0 to 4, where 0=almost never (less than once a month) and 4=always (several times a day).

    Measured: Baseline, End of 8-session Treatment (assessed up to 18 weeks)

  4. TF-CBT Knowledge Score

    Test of the level of knowledge of the lay counselors about TF-CBT, as assessed by the TF-CBT Knowledge Assessment. Higher scores represent greater group leader knowledge of TF-CBT. Scores could range from 0 to 32.5. The knowledge test was administered to all lay counselors at the end of their TF-CBT training to confirm their readiness to deliver the intervention. For each sequence, training occurred just before implementation of the intervention.

    Measured: Immediately Post-Training (on final day of training for the sequence, up to 6 days)

  5. Change in Prosocial Behavior (Child Report)

    Change in behavioral strengths of the child, as assessed by the Prosocial Behavior subscale of the Strengths and Difficulties Questionnaire before and after the intervention. There are 5 items asking about the degree to which the child reports prosocial behavior. Each item has 3 possible responses on a scale of 0 to 2, where 0=not at all true and 2=certainly true. The total score summing across the 5 items could range from 0 to 10. Higher scores are more favorable, representing more prosocial behavior.

    Measured: Baseline, End of 8-session Treatment (assessed up to 18 weeks)

  6. Change in Behavioral Problems (Guardian Report)

    Change in behavioral problems of the child, as assessed by the Conduct Problems subscale of the Strengths and Difficulties Questionnaire, including additional items validated locally. There are 9 items asking about the degree to which the guardian reports conduct problems observed in the child. Each item has 3 possible responses on a scale of 0 to 2, where 0=not at all true and 2=certainly true. The total score summing across the 5 items could range from 0 to 18. Lower scores are more favorable, representing decreased behavioral problems.

    Measured: Baseline, End of 8-session Treatment (assessed up to 18 weeks)

  7. School Attendance

    School attendance measured by the number of school days missed in the past two weeks, as reported by the guardian.

    Measured: Baseline

  8. Change in Proportion of Children Engaged in Excessive Child Labor for Pay

    Change in proportion of children engaged in excessive child labor for pay in the past week, as assessed by the Child Work and Labor Questionnaire and reported by the child. UNICEF's definition of excessive labor for children aged 12 and older is 14 hours per week for pay and 28 hours per week with or without pay. This is constructed as a binary variable, and we present a difference in the proportion of children who worked 14 or more hours in the past week for income-generating activities (work without pay was not assessed). Lower proportion is more favorable, representing fewer children engaged in excessive child labor for pay.

    Measured: Baseline to third annual follow-up

  9. Change in Proportion of Children Engages in Excessive Household Assistance Without Pay

    Change in proportion of children engaged in chores (non-income generating work around the home) in the past week, as reported by the child. This is constructed as a binary variable, and we present a difference in the proportion of children who did chores for 14 or more hours in the past week. Lower proportion is more favorable, representing fewer children engaged in excessive household assistance without pay.

    Measured: Baseline to third annual follow-up

  10. Safer Sex Peer Norms Score

    Agreement exhibited by the child with positive peer norms regarding sexual behavior, as assessed by the Safer Sex Peer Norms subscale on the Safer Sex Peer Norms and Substance Use Questionnaire. This measure is only administered if the child is 16 or older, so for this outcome, we report specifically on the Safer Sex Peer Norms assessment collected at the 3rd annual follow-up timepoint. Scores are the sum of 7-item asking about agreement with the item. Each item is measured on a scale of 1 to 4, where 1=strongly disagree and 4=strongly agree. The range of total scores is 0 to 28. Higher scores are more favorable, representing stronger agreement with positive peer norms.

    Measured: Third annual follow-up

  11. Change in Proportion of Children Reporting Any Current Substance Use

    Change in proportion of children reporting any current alcohol, tobacco, or other drug use, as assessed by the Safer Sex Peer Norms and Substance Use Questionnaire and reported by the child. This is reported as a binary variable representing the proportion of children who report current drug use or drinking alcohol in the past 7 days or using tobacco in the past 7 days. Lower proportion is more favorable.

    Measured: Baseline to third annual follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2017
  2. Study start1 Feb 2018
  3. Primary completion25 Jan 2024
  4. Study completion25 Jan 2024

Resources

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
Crossover
Model description
Child mental health outcomes are assessed using an incomplete stepped wedge, cluster randomized controlled trial with 7 sequences. Child participants \& one guardian each are randomized to receive the treatment (therapy sessions) from lay counselors in the Health (Community Health Volunteer) or Education (teacher) sector, with timing based on the sequence to which their village cluster was randomly assigned. These participants are the focus of the Interventional Study Design in Aim 3. Also included are lay counselors \& site leaders (Head Teachers, Deputy Teachers, \& Community Health Extension Workers), given that it is a hybrid effectiveness-implementation trial. These participants, the focus of implementation questions in Aims 1 \& 2, provide TF-CBT \& do not receive therapy sessions themselves. The village clusters are randomized to sequences in the SW-CRT, \& if randomized to sequences 2-7, they receive coaching support informed by sequence 1 on how to effectively implement TF-CBT.
Masking
None (open label)
Enrolment
956 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03243396
Sponsor's protocol ID
Pro00081913
Other IDs
1R01MH112633
Acronym
BASIC
Status last verified
Mar 2025
First submitted
13 Jul 2017
Last updated
1 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thornicroft G, Alem A, Antunes Dos Santos R, Barley E, Drake RE, Gregorio G, Hanlon C, Ito H, Latimer E, Law A, Mari J, McGeorge P, Padmavati R, Razzouk D, Semrau M, Setoya Y, Thara R, Wondimagegn D. WPA guidance on steps, obstacles and mistakes to avoid in the implementation of community mental health care. World Psychiatry. 2010 Jun;9(2):67-77. doi: 10.1002/j.2051-5545.2010.tb00276.x.

    PubMed 20671888

  • Saxena S, Thornicroft G, Knapp M, Whiteford H. Resources for mental health: scarcity, inequity, and inefficiency. Lancet. 2007 Sep 8;370(9590):878-89. doi: 10.1016/S0140-6736(07)61239-2.

    PubMed 17804062

  • Eaton J, McCay L, Semrau M, Chatterjee S, Baingana F, Araya R, Ntulo C, Thornicroft G, Saxena S. Scale up of services for mental health in low-income and middle-income countries. Lancet. 2011 Oct 29;378(9802):1592-603. doi: 10.1016/S0140-6736(11)60891-X. Epub 2011 Oct 16.

    PubMed 22008429

  • Betancourt TS, Chambers DA. Optimizing an Era of Global Mental Health Implementation Science. JAMA Psychiatry. 2016 Feb;73(2):99-100. doi: 10.1001/jamapsychiatry.2015.2705. No abstract available.

    PubMed 26720304

  • Patel V, Chowdhary N, Rahman A, Verdeli H. Improving access to psychological treatments: lessons from developing countries. Behav Res Ther. 2011 Sep;49(9):523-8. doi: 10.1016/j.brat.2011.06.012. Epub 2011 Jul 7.

    PubMed 21788012

  • Cragun D, Radford C, Dolinsky JS, Caldwell M, Chao E, Pal T. Panel-based testing for inherited colorectal cancer: a descriptive study of clinical testing performed by a US laboratory. Clin Genet. 2014 Dec;86(6):510-20. doi: 10.1111/cge.12359. Epub 2014 Mar 20.

    PubMed 24506336

  • McAlearney AS, Walker D, Moss AD, Bickell NA. Using Qualitative Comparative Analysis of Key Informant Interviews in Health Services Research: Enhancing a Study of Adjuvant Therapy Use in Breast Cancer Care. Med Care. 2016 Apr;54(4):400-5. doi: 10.1097/MLR.0000000000000503.

    PubMed 26908085

  • Marcus Thygeson N, Solberg LI, Asche SE, Fontaine P, Gregory Pawlson L, Scholle SH. Using fuzzy set qualitative comparative analysis (fs/QCA) to explore the relationship between medical "homeness" and quality. Health Serv Res. 2012 Feb;47(1 Pt 1):22-45. doi: 10.1111/j.1475-6773.2011.01303.x. Epub 2011 Aug 22.

    PubMed 22092269

  • Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

    PubMed 22310560

  • Kohn R, Saxena S, Levav I, Saraceno B. The treatment gap in mental health care. Bull World Health Organ. 2004 Nov;82(11):858-66. Epub 2004 Dec 14.

    PubMed 15640922

  • Thornicroft G, Cooper S, Bortel TV, Kakuma R, Lund C. Capacity building in global mental health research. Harv Rev Psychiatry. 2012 Jan-Feb;20(1):13-24. doi: 10.3109/10673229.2012.649117.

    PubMed 22335179

  • Patel V. The future of psychiatry in low- and middle-income countries. Psychol Med. 2009 Nov;39(11):1759-62. doi: 10.1017/s0033291709005224.

    PubMed 20162837

  • Patel V, Araya R, Chatterjee S, Chisholm D, Cohen A, De Silva M, Hosman C, McGuire H, Rojas G, van Ommeren M. Treatment and prevention of mental disorders in low-income and middle-income countries. Lancet. 2007 Sep 15;370(9591):991-1005. doi: 10.1016/S0140-6736(07)61240-9.

    PubMed 17804058

  • van Ginneken N, Tharyan P, Lewin S, Rao GN, Meera SM, Pian J, Chandrashekar S, Patel V. Non-specialist health worker interventions for the care of mental, neurological and substance-abuse disorders in low- and middle-income countries. Cochrane Database Syst Rev. 2013 Nov 19;(11):CD009149. doi: 10.1002/14651858.CD009149.pub2.

    PubMed 24249541

  • Bolton P, Bass J, Neugebauer R, Verdeli H, Clougherty KF, Wickramaratne P, Speelman L, Ndogoni L, Weissman M. Group interpersonal psychotherapy for depression in rural Uganda: a randomized controlled trial. JAMA. 2003 Jun 18;289(23):3117-24. doi: 10.1001/jama.289.23.3117.

    PubMed 12813117

Questions about this trial

What is this clinical trial studying?

A study testing Trauma-Focused Cognitive Behavioral Therapy in people with Grief and Post Traumatic Stress Disorder, run by Duke University at 1 site in Kenya.

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 9 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 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. 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 1 Apr 2025). 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?

Change in Posttraumatic Stress Symptoms (Child Report) (time frame: Baseline, End of 8-session Treatment (assessed up to 18 weeks)). The study lists 4 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 NCT03243396, which also lists 115 linked publications.

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 1 Apr 2025.

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