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

Depression Clinical Trial

— BASIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243396
• Other study ID #: Pro00081913
• Secondary ID: 1R01MH112633
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: January 25, 2024

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2296
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Depression
• Grief
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Trauma-Focused Cognitive Behavioral Therapy
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).

Locations

Country	Name	City	State
Kenya	ACE Africa	Bungoma	Bungoma County

Sponsors (5)

Lead Sponsor	Collaborator
Duke University	Ace Africa, Johns Hopkins University, National Institute of Mental Health (NIMH), University of Washington

Country where clinical trial is conducted

Kenya, 

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* Note: There are 113 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship Closeness	Closeness of the child's relationship with their caregiver, as assessed by caregiver report in the Closeness subscale of the Child-Parent Relationship Scale. Higher scores represent greater closeness.	End of 8-session Treatment (assessed up to 18 weeks)
Other	Relationship Conflict	Conflict in the child's relationship with their caregiver, as assessed by caregiver report in the Conflict subscale of the Child-Parent Relationship Scale. Higher scores represent more conflict.	End of 8-session Treatment (assessed up to 18 weeks)
Other	Guardian-provided Social Support	Social support provided to the child by their parent or guardian, as assessed by child report in the Child and Adolescent Social Support Scale. Higher scores represent more support.	End of 8-session Treatment (assessed up to 18 weeks)
Other	Intervention Acceptability	Assessed using both reflective and formative measures at the group leader level. The reflective measure is the Acceptability of Intervention Measure (AIM), with scores ranging from 1 (least acceptable) to 5 (most acceptable) calculated as a mean score to reflect the acceptability of the TF-CBT intervention in a given setting. The formative measure is the Johns Hopkins University (JHU) Implementation science case for Acceptability (using only 5 items that mapped directly onto Proctor's definition of acceptability and did not overlap with items on the AIM measure). This is not treated as a scale, and items are analyzed independently of each other.	End of first year of site implementation (2 groups, 8 sessions each)
Other	Intervention Feasibility	Assessed using both reflective and formative measures at the group leader level. The reflective measure is the Feasibility of Intervention Measure (FIM), with scores ranging from 1 (least feasible) to 5 (most feasible) calculated as a mean score to reflect the feasibility of implementing TF-CBT in a given setting. The formative measure is the Johns Hopkins University Implementation science scale for Feasibility (using 12 items). This is not treated as a scale, and items are analyzed independently of each other. 2 additional items were included that inquired about the estimated hours per week that respondents felt Pamoja Tunaweza/TF-CBT would require, given the importance of this information for understanding added workload and feasibility for providers in the two contexts ("On average, how many hours per week do you spend on Pamoja Tunaweza/TF-CBT [e.g., preparing for sessions, delivering sessions, and supervision]?").	End of first year of site implementation (2 groups, 8 sessions each)
Other	Intervention Appropriateness	A formative measure is used to assess perceived appropriateness of the TF-CBT intervention at the group leader level, with scores ranging from 1 (least appropriate) to 5 (most appropriate). This is not treated as a scale, and items are analyzed independently of each other. Six items were adapted from the Johns Hopkins University implementation measures that aligned with Proctor and colleagues' (20) definition of appropriateness. Minor changes were made to fit wording to the local context. Two additional items were developed to measure appropriateness domain content for which Johns Hopkins University items did not exist. Given challenges in creating new items, Hujig's Theoretical Domains Framework was used when possible to guide item creation (42). In the resulting 8-item measure, 4 items assessed the perceived fit of delivering TF-CBT with one's role. The additional 4 items assessed the perceived fit of delivering TF-CBT within the specific setting.	End of first year of site implementation (2 groups, 8 sessions each)
Primary	Change in Posttraumatic Stress Symptoms (child report)	Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (child report). Higher scores represent more severe symptoms.	Baseline, End of 8-session Treatment (assessed up to 18 weeks)
Primary	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 fidelity and adherence to TF-CBT.	End of first year of site implementation (2 groups, 8 sessions each)
Primary	Adoption	Adoption is is a binary yes/no outcome defined as delivery of 2 on-site 8-session TF-CBT groups by a 3-counselor team and is measured by counselor self-report (and confirmed by supervisors). Assessed for each "trimester" end for schools and communities, summarized over the year.	End of first year of site implementation (2 groups, 8 sessions each)
Primary	Sustainment	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).	Two years after the first TF-CBT groups for each site
Secondary	Change in Posttraumatic Stress Symptoms (caregiver report)	Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (caregiver report). Higher scores represent more severe symptoms.	Baseline, End of 8-session Treatment (assessed up to 18 weeks)
Secondary	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). Higher scores represent more severe symptoms.	Baseline, End of 8-session Treatment (assessed up to 18 weeks)
Secondary	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.	Baseline, End of 8-session Treatment (assessed up to 18 weeks)
Secondary	TF-CBT Knowledge	Test of the level of knowledge of the group leader about TF-CBT, as assessed by the TF-CBT Knowledge Assessment. Higher scores represent greater group leader knowledge of TF-CBT.	Immediately Post-Training (on final day of training)
Secondary	Prosocial Behavior (child report)	Behavioral strengths of the child, as assessed by the Prosocial Behavior subscale of the Strengths and Difficulties Questionnaire. Higher scores represent more prosocial behavior.	End of 8-session Treatment (assessed up to 18 weeks)
Secondary	Behavioral Difficulties (guardian report)	Behavioral difficulties of the child, as assessed by the Conduct Problems subscale of the Strengths and Difficulties Questionnaire. Higher scores represent more abnormal symptoms.	End of 8-session Treatment (assessed up to 18 weeks)
Secondary	School Attendance	School attendance measured by the number of school days missed in the past two weeks, as reported by the guardian.	At study completion, average 1.5 years
Secondary	Child Labor	Hours of paid labor required of the child in the past week, as assessed by the Child Work and Labor Questionnaire. 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.	At study completion, average 1.5 years
Secondary	Household Assistance	Hours of chores (non-income generating work around the home) required of the child in the past week, as reported by the child.	At study completion, average 1.5 years
Secondary	Safer Sex Peer Norms	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. Higher scores represent stronger agreement with positive peer norms. This measure is only administered at any follow up (usually the 2nd or 3rd-year) if the participant is 16 or older.	At study completion, average 1.5 years
Secondary	Substance Use	Substance use is a binary yes/no outcome defined as any alcohol, tobacco, or other drug use reported by the child, as assessed by the Substance Use subscale on the Safer Sex Peer Norms and Substance Use Questionnaire.	At study completion, average 1.5 years