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NCT06672562

Narrative Enhancement and Cognitive Therapy for Self-Stigma in Youth

StatusCompleted
PhaseNot applicable
Primary completion
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 5 more changesShow less
    • Enrollment target: estimated 96 to confirmed 97
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Collaborators: details revised at 1 of 3 entries
    • Publications: details revised at 2 of 2 entries
  2. Primary and study completion dates pushed to Jun 30, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Nov 2024 to Oct 28, 2024
    • Site details revised
    v2
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants Providing Consent to Participate in the Study
Timeframe: Duration of the study enrollment period, up to 1 year
Number of Participants Providing Consent in Two Months
Timeframe: Duration of the study enrollment period, up to 1 year
Number of Sessions Attended by Participants Randomized to NECT-Y
Timeframe: From week 1 to week 14 of the NECT-Y intervention, up to 14 weeks
Number of Participants Completing Study Questionnaires at Week 15
Timeframe: Week 15 (post-treatment)
Number of Participants Completing Study Questionnaires at Week 28
Timeframe: Week 28 (3-month follow up)
Number of Questionnaires Completed at Week 15
Timeframe: Week 15 (post-treatment)
Number of Questionnaires Completed at Week 28
Timeframe: Week 28 (3-month follow up)
Number of Participants With Study-Related Adverse Events as Assessed by an Institutional Adverse Event Log
Timeframe: From study enrollment to 3-month follow up, up to 28 weeks

Secondary (3)

Was NECT-Y Acceptable to Youth Participants?
Was NECT-Y Acceptable to Co-Facilitators?
Was NECT-Y Delivered With Fidelity in Relation to the Intervention Manual as Assessed by a Standardized Fidelity Scale?

Arms and interventions

NECT-YExperimental

Virtual 14-week Narrative Enhancement and Cognitive Therapy group intervention that will be co-facilitated by a clinician and peer support worker.

Treatment as usualPlacebo comparator

No study-specific care will be provided to these participants.

Behavioral: Narrative Enhancement and Cognitive Therapy

Other: Usual care

Sites

1 site in 1 country

  • Centre for Addiction and Mental HealthToronto, Ontario, Canada