NCT06440031

Brief Summary

Suicide and self-harm are global disease burden that contributes significantly to years of lost life and mortality.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

12 months

First QC Date

May 28, 2024

Last Update Submit

May 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in acceptance and satisfaction with the intervention

    Primary outcome measure would be assessed using the Service Satisfaction Scale

    Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention

Secondary Outcomes (6)

  • Change in suicidal ideation

    Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention

  • Change in hopelessness

    Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention

  • Change in Health Status

    Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention

  • Change in repetition rate's of self-harm

    Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention

  • Change in use of health services

    Change is being assessed from baseline, end of intervention at 12 weeks, and at 12 weeks post-intervention

  • +1 more secondary outcomes

Study Arms (2)

CaMaPi

EXPERIMENTAL
Behavioral: CaMaPi

TAU

ACTIVE COMPARATOR
Other: TAU

Interventions

CaMaPiBEHAVIORAL

CaMaPi is a manually assisted brief psychological intervention that is based on the principles of Cognitive Behaviour Therapy (CBT). The intervention includes psycho-education and a comprehensive cognitive behavioural assessment of the suicidal ideation and self-harm attempt using virtual stories of four young people to be delivered in 8-10 sessions for over three months

CaMaPi
TAUOTHER

Treatment as Usual (TAU) is routine care, such as diagnosis, assessment, psychotherapy, monitoring and any form of intervention (e.g., medication prescription) available at the collaborating service.

TAU

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients aged 16-24 years presenting to the participating services, and emergency departments or admitted after an episode of self-harm to the participating hospitals or self-referrals.
  • Participants will have to be living within the catchment area of the participating practices, services and hospitals.
  • Not needing inpatient psychiatric treatment.

You may not qualify if:

  • Severe mental illness (such as Psychotic disorder).
  • Conditions limiting engagement with assessment/intervention.
  • Temporary resident unlikely to be available for follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jidong DE, Ike TJ, Taru MY, Pwajok JY, Nwoga CN, Jidong JE, Mwankon SB, Francis C, Husain N. Culturally Adapted Manual-Assisted Psychological Intervention (CaMaPI) for Adolescents/Young People With a History of Self-Harm and Suicidal Ideation in Nigeria: A Randomised Controlled Feasibility Trial. Clin Psychol Psychother. 2025 May-Jun;32(3):e70098. doi: 10.1002/cpp.70098.

MeSH Terms

Conditions

Self-Injurious BehaviorSuicidal Ideation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSuicide

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 28, 2024

First Posted

June 3, 2024

Study Start

July 1, 2024

Primary Completion

June 30, 2025

Study Completion

September 30, 2025

Last Updated

June 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share