Clinical trial NCT05737667: Advancing mHealth-supported Adoption and Sustainment of an Evidence-based Mental Health Intervention in Sierra Leone
Official title: Advancing mHealth-supported Adoption and Sustainment of an Evidence-based Mental Health Intervention for Youth in a School-based Delivery Setting in Sierra Leone
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-02-21
Enrollment: 1454
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will examine a new implementation strategy for the Youth Readiness Intervention (YRI), an evidence-based mental health intervention. The strategy will (a) leverage a delivery setting (schools) and workforce (teachers) used effectively in low- and middle- income countries; and (b) innovate with technology and mHealth tools to enhance mental health service delivery quality. The YRI will be implemented as an extracurricular resilience-building after school activity in Sierra Leone. Teachers will deliver the YRI and receive either mobile phone-supported supervision or standard in-person supervision. Mobile-based supervision will integrate WhatsApp, a free cross-platform messaging and voice service used widely throughout Africa, with mHealth digital tools. The mHealth tools will support supervision through key features, including voice activated content, fillable forms (i.e., YRI fidelity checklist), and visual dashboards to monitor fidelity. A hybrid type 3 implementation-effectiveness design will allow for evaluation of both mobile phone-based supervision as a new implementation strategy, and clinical effectiveness of the YRI on youth mental and behavioral health as secondary outcomes.

Detailed description: This study will examine a new implementation strategy for the Youth Readiness Intervention (YRI), an evidence-based mental health intervention. The strategy will (a) leverage a delivery setting (schools) and workforce (teachers) used effectively in low- and middle- income countries; and (b) innovate with technology and mHealth tools to enhance mental health service delivery quality. The YRI will be implemented as an extracurricular resilience-building after school activity in Sierra Leone. Teachers will deliver the YRI and receive either mobile phone-supported supervision or standard in-person supervision. Mobile-based supervision will integrate WhatsApp, a free cross-platform messaging and voice service used widely throughout Africa, with new mobile-based digital tools. The mHealth tools will support supervision through key features, including voice activated content, fillable forms (i.e., YRI fidelity checklist), visual dashboards to monitor fidelity, and training videos to support school-based YRI delivery.

The Exploration, Preparation, Implementation, Sustainment framework, a broad multilevel, context-sensitive implementation science model, will guide the study. A hybrid type 3 implementation-effectiveness design will allow for evaluation of both mobile phone-based supervision as a new implementation strategy, and clinical effectiveness of the YRI on youth mental and behavioral health as secondary outcomes.

Aim 1 (Exploration and Preparation) will investigate barriers and facilitators to successful YRI implementation aided by mobile-based tools in Sierra Leone's secondary schools. A mixed methods evaluation with teachers, principals, and government ministry officials will inform co-development of an implementation blueprint prior to YRI delivery. User-centered design methods will be used to adapt the mHealth supervision app and incorporate WhatsApp to create an integrated user model of mobile phone-based supervision. Aim 2 (Implementation) will examine the feasibility, acceptability, cost, and fidelity to the YRI delivered by teachers receiving mobile-based supervision compared with those receiving standard supervision via a mixed methods approach. Aim 3 (Impact of Delivery Approach on YRI Effectiveness) will compare the effectiveness of the YRI in improving mental health, emotion regulation and daily functioning in youth (aged 14-24) when delivered in school settings by teachers who receive either mobile-based supervision (N=480 youth) or those who receive standard supervision (N=480 youth). Aim 4 (Sustainment) will (a) investigate mechanisms of adoption and sustainment of the YRI delivered by teachers through a mixed methods evaluation with teachers, youth, and principals; and (b) conduct a cost-effectiveness and return on investment analysis to evaluate relative costs vs. benefits of the YRI from a broad societal perspective, including educational outcomes.

Eligibility criteria: School Inclusion Criteria:

* We will include secondary schools in the Western Region that are willing to provide the Youth Readiness Intervention (YRI) as an extracurricular activity

School Exclusion Criteria:

* We will exclude schools that do not meet the inclusion criteria.

Teacher Inclusion Criteria:

* We will include teachers who are (a) currently employed at a Western Region urban or rural secondary school; (b) willing to provide the YRI as an extracurricular activity

Teacher Exclusion Criteria:

* We will exclude teachers who do meet inclusion criteria.

Youth Inclusion Criteria:

* We will include youth who are (a) currently enrolled in a secondary school in the Western Region (urban or rural); (b) male or female aged 14-24; (c) able to attend after school activities. We will require both youth assent and parental consent for all youth under age 18.

Youth Exclusion Criteria:

* We will exclude youth who do not meet all inclusion criteria and/or who report active, severe suicidality or psychosis as determined by a study social worker.

Primary outcomes:
measure: Fidelity
timeFrame: For 12 weeks, starting from the date of the first YRI session
measure: Acceptability
timeFrame: An average of 24 weeks
measure: Appropriateness
timeFrame: An average of 24 weeks
Secondary outcomes:
measure: emotion regulation skills
timeFrame: An average of 24 weeks
measure: Anxiety and Depression
timeFrame: An average of 24 weeks
measure: Functional Impairment
timeFrame: An average of 1 year
Other outcomes:
Locations:
city: Freetown
country: Sierra Leone
facility: Innovations for Poverty Action
Study officials:
affiliation: Brown University
name: Alethea Desrosiers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Betancourt TS, McBain R, Newnham EA, Akinsulure-Smith AM, Brennan RT, Weisz JR, Hansen NB. A behavioral intervention for war-affected youth in Sierra Leone: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Dec;53(12):1288-97. doi: 10.1016/j.jaac.2014.09.011. Epub 2014 Oct 2.