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Mental HealthNCT05737667

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

A study testing Youth Readiness Intervention (YRI) in people with Mental Health, run by Brown University at 1 site in Sierra Leone.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Health
What is being tested?
Youth Readiness Intervention (YRI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,454 participants
Where
1 siteSierra Leone
Study dates
15 Feb 2023to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 14 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Sierra Leone1 site

  • Innovations for Poverty Action

    Freetown

Other trials in Sierra Leone

About this study

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

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.

Read the 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.

Conditions
Mental Health
Being tested
Youth Readiness Intervention (YRI)
Medical subject headings
Psychological Well-Being

What participants receive

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

  • Youth Readiness Intervention (YRI)Behavioural

    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.

Study groups in NCT05737667
Study groupRoleWhat they receive
YRI+Mobile SupervisionExperimentalYouth Readiness Intervention delivered by teachers receiving mobile-based supervision
Receives: Behavioral: Youth Readiness Intervention (YRI)
YRI+Standard SupervisionActive comparatorYouth Readiness Intervention delivered by teachers receiving standard supervision
Receives: Behavioral: Youth Readiness Intervention (YRI)
ControlNo interventionWait listed control

What is being measured

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

  1. 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.

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

  2. 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.

    Measured: An average of 24 weeks

  3. 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.

    Measured: An average of 24 weeks

Secondary outcomes (3)

  1. emotion regulation skills

    Emotion regulation skills, or the ability to modulate emotional responses, will be measured with the Difficulties in Emotion Regulation Scale. This is a 36-item scale and responses are scored on a 5-point Likert scale: 1=Almost Never, 2=Sometimes, 3=About half the time, 4=Most of the time, 5=Almost always. Higher scores indicate poorer emotion regulation skills.

    Measured: An average of 24 weeks

  2. Anxiety and Depression

    Anxiety and Depression will be measured with the Hopkins Symptom Checklist, a 25-item inventory that measures symptoms of anxiety and depression. Part I of the measure has 10 items assessing anxiety symptoms and Part II has 15 items assessing depression symptoms. Each item is rated on a 4-point scale: 1 = Not at all, 2 = A little, 3 = Quite a bit, and 4 = Extremely. Item scores are summed to derive scores for the total scale and subscales, i.e., anxiety and depression. Higher scores reflect worse functioning.

    Measured: An average of 24 weeks

  3. Functional Impairment

    Functional Impairment will be measured by the World Health Organization Disability Assessment Schedule short-form. This scale contains 12 items and assesses functioning across five domains: mobility, self-care, understanding and communication, life activities and societal participation. Items are scored on a 5-point Likert scale (0-4) and summed to derive a total scale. Higher scores reflect worse functioning.

    Measured: An average of 1 year

Timeline

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

  1. First posted21 Feb 2023
  2. Study start15 Feb 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,454 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05737667
Sponsor's protocol ID
2022003442
Other IDs
R01MH130320
Status last verified
Jun 2026
First submitted
2 Feb 2023
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The PI and her collaborators will abide by the principles for sharing research resources and data, as described by NIH in NIH Data Sharing Policy and Implementation Guidance and more specifically in "Data Sharing Expectations for National Institute of Mental Health (NIMH)-funded Clinical Trials". The data generated in this clinical trial will be entered into the NIMH Data Archive repository, as required by the Notice of Award, and presented at national and international conferences and published in a timely fashion. All final peer-reviewed manuscripts that arise from this trial will be submitted to the digital archive PubMed Central. Published data will be available in print or electronically from publishers, subject to subscription or printing charges. Research data that document, support and validate research findings will be made available after the main findings from the final research data set have been published.

Publications

  • 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.

    PubMed 25457927

  • 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.

    PubMed 38310232

Questions about this trial

What is this clinical trial studying?

A study testing Youth Readiness Intervention (YRI) in people with Mental Health, run by Brown University at 1 site in Sierra Leone.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. 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 Sierra Leone. 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?

This study is still under way. Results are not available in the source record yet.

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?

Fidelity (time frame: For 12 weeks, starting from the date of the first YRI session). The study lists 3 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 NCT05737667, which also lists 2 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 22 Jun 2026.

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