NCT05103540

Brief Summary

The research will use the Social Ecologic Model of behavior and WHO mhGAP framework to design a comprehensive intervention across three levels (individual, interpersonal, and social) of influence. The study will then pilot the intervention in 15 secondary schools through a Stepped-Wedge Cluster-Randomized trial. After screening for eligibility and selecting participating schools and individuals, investigators will randomize at the cluster level and switch the groups from control to intervention arms at three months' intervals till the research has moved all the clusters. The study will collect data at baseline, the switch points, and the end of the study. The goal is to evaluate the feasibility, effectiveness of a comprehensive suicide behavior prevention intervention among in-school adolescents in Nigeria. Another aim is to identify barriers and facilitators of implementation and the best practices for scaling up the intervention. It is hypothesized that because our intervention is based on the best contextual evidence and built on a sound theoretical model, it will successfully mitigate suicide ideation. Also, the nature and efficiency of the stepped wedge cluster randomized design will enhance the feasibility in the local context, characterized by political, logistic, and ethical constraints.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Jul 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Jul 2025Jun 2028

First Submitted

Initial submission to the registry

October 21, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
3.7 years until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

2.9 years

First QC Date

October 21, 2021

Last Update Submit

August 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Suicide Ideation

    Adolescent Suicide Ideation measured using the Positive and Negative Suicide Ideation (PANSI) Inventory. The scores range from six to thirty for PANSI-Positive Inventory (PI) and eight to 40 for PANSI-Negative Suicide Inventory (NSI). Higher scores on PANSI-NSI scale and lower marks on PANSI-PI) symbolize the higher frequency of suicidal thoughts.

    12 weeks

Secondary Outcomes (3)

  • Gratitude

    12 weeks

  • Grit

    12 weeks

  • Mental Health Status

    12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Comprehensive theory-based suicide behavior program

Behavioral: Comprehensive SEM-Based Program

Control

NO INTERVENTION

No intervention will be given to the group

Interventions

The SEM theorizes that there are multiple inter-related levels of influences on human behavior, and a successful preventive program should address factors at each stratum. My intervention addresses three levels; individual, interpersonal, and social. Firstly, the research will collaborate with relevant stakeholders to design and obtain a commitment from the schools to a suicidal behavior prevention policy and protocol document. Secondly, the intervention will train staff and students on best practices to improve students' connectedness thereby, creating a positive school environment. Thirdly, the study will identify and train gatekeepers on the proper response to suicidal thoughts and other suicidal behaviors; and serve as the link between the students and a school-linked mental health specialist. We will train the gatekeepers to use school-based screening tools. Lastly, this research will educate all students on suicidal behaviors.

Intervention

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Duly enrolled students
  • Aged 10-19 years
  • No plans of leaving the school in the next year
  • Give consent
  • Parental/guardians' assent

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Olumide Abiodun

    Babcock University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 21, 2021

First Posted

November 2, 2021

Study Start

July 1, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

All study data will be de-identified