NCT06582901 Interventions for Clinical High Risk Youth in Tunisia
| NCT ID | NCT06582901 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Clinical High Risk for Psychosis (CHR) |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2023-09-01 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Study participants will take part in one of the two types of treatments aimed at improving daily functioning as follows: either a Cognitive Training (CT) Program or an Enhanced - Treatment as Usual (E-TAU) Group. All group treatments will be provided at Razi Hospital and one of the sessions will be conducted at home. The Cognitive (thinking skills) Training and Neuropsychological Education Approach to Remediation (CT-NEAR) is a form of cognitive (thinking skills) training that consists of computer-game like brain exercises, learning about thinking skills strategies, and a "bridging group" to help participants use what is learned in daily life. Cognitive exercises are generally fun and playful and are done on a computer. The aim is to train thinking skills and ability to function better in daily life such as at school, university, or at work, or with friends and family. The program lasts 12 weeks with two weekly sessions in groups of 3 to 4 participants. Each session is 1½ hours in length and one of the sessions is which lasts 30 minutes is conducted at home using a tablet that will be provided by the study investigators.
Eligibility Criteria
Inclusion Criteria: * Meets Comprehensive Assessment for At Risk Mental States (CAARMS) criteria for Clinical High Risk * If under the age of 18, the subject has a parent or guardian who can sign consent forms * Premorbid Intelligence Quotient not less than 70 * Sufficient fluency in Arabic, French, or English to avoid invalidating research measures * Residence likely within commuting distance of Razi University Hospital Exclusion Criteria: * Evidence of known neurological disorder, e.g. epilepsy or significant head injury that could account for the CHR symptoms * Evidence of significant and habitual alcohol or substance use in the 6 months prior to study entry * Evidence that the clinical high-risk symptoms were substance-induced
Contact & Investigator
Joseph Ventura, Ph.D.
PRINCIPAL INVESTIGATOR
UCLA Department of Psychiatry & Biobehavioral Sciences
Frequently Asked Questions
Who can join the NCT06582901 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 28 Years, studying Clinical High Risk for Psychosis (CHR). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06582901 currently recruiting?
Yes, NCT06582901 is actively recruiting participants. Contact the research team at jventura@mednet.ucla.edu for enrollment information.
Where is the NCT06582901 trial being conducted?
This trial is being conducted at Tunis, Tunisia.
Who is sponsoring the NCT06582901 clinical trial?
NCT06582901 is sponsored by University of California, Los Angeles. The principal investigator is Joseph Ventura, Ph.D. at UCLA Department of Psychiatry & Biobehavioral Sciences. The trial plans to enroll 54 participants.