Advancing mHealth-supported Adoption and Sustainment of an Evidence-based Mental Health Intervention in Sierra Leone

NCT05737667 | Active Not Recruiting

• 2 other identifiers: 2022003442R01MH130320
• Study Type: interventional
• Target: 1,454
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health

Outcome Measures

Primary Outcomes (3)

• Fidelity

  Fidelity will be measured with the YRI Fidelity Checklist, a tool developed and tested in previous trials that is completed after each YRI session.

  For 12 weeks, starting from the date of the first YRI session

• Acceptability

  Acceptability, or the level of satisfaction with the intervention, will be assessed with the Johns Hopkins University Implementation Science Questionnaire. The scale has 12 items scored on a 4-point Likert scale: 1=Not at all, 2=A little bit, 3=A moderate amount, 4=A lot. Higher scores mean greater acceptability.

  An average of 24 weeks

• Appropriateness

  Appropriateness, or the relevance and fit of the intervention, will be assessed with Johns Hopkins University Implementation Science Questionnaire. The scale has 12 items scored on a 4-point Likert scale: 1=Not at all, 2=A little bit, 3=A moderate amount, 4=A lot. Higher scores mean greater appropriateness.

  An average of 24 weeks

Secondary Outcomes (3)

• emotion regulation skills

  An average of 24 weeks

• Anxiety and Depression

  An average of 24 weeks

• Functional Impairment

  An average of 1 year

Study Arms (3)

YRI+Mobile Supervision

EXPERIMENTAL

Youth Readiness Intervention delivered by teachers receiving mobile-based supervision

Behavioral: Youth Readiness Intervention (YRI)

YRI+Standard Supervision

ACTIVE COMPARATOR

Youth Readiness Intervention delivered by teachers receiving standard supervision

Behavioral: Youth Readiness Intervention (YRI)

Control

NO INTERVENTION

Wait listed control

Interventions

Youth Readiness Intervention (YRI) BEHAVIORAL

The YRI is a culturally adapted group intervention that integrates common practice elements of cognitive behavioral and interpersonal therapies. The YRI's core treatment elements target improving emotion regulation skills, interpersonal functioning, and problem-solving skills. The YRI has 12 session that last about 90 minutes. The YRI will be delivered in schools by teachers receiving either mobile-based supervision or standard, in-person supervision.

YRI+Mobile Supervision; YRI+Standard Supervision

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Brown University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Innovations for Poverty Action

Freetown, Sierra Leone

Location

Related Publications (2)

• 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.

  PMID: 25457927 BACKGROUND

• Desrosiers A, Carrol B, Ritsema H, Higgins W, Momoh F, Betancourt TS. Advancing sustainable implementation of an evidence-based mental health intervention in Sierra Leone's schools: protocol for a hybrid type 3 implementation-effectiveness trial. BMC Public Health. 2024 Feb 3;24(1):362. doi: 10.1186/s12889-024-17928-w.

  PMID: 38310232 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Alethea Desrosiers, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 21, 2023
• Study Start: February 15, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: 6 months after publication of study results

Locations

SI (1)