Interventions for Clinical High Risk Youth in Tunisia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-28
SponsorUniversity of California, Los Angeles
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive training (CT) plus the neuropsychological educational approach to cognitive remediation (NEAR) model and an Enhanced - Treatment as Usual (E-TAU)
BehavioralPsychosocial interactions computer-based cognitive training (CT) administered in a group setting that includes the Neuropsychological Educational Approach to Cognitive Remediation (NEAR) model:
Enhanced - Treatment as Usual
BehavioralThe Enhanced-Treatment as Usual (E-TAU) sessions are delivered in a group therapy format and guided by the principles of Cognitive Behavioral Therapy (CBT). Participants learn to develop coping skills and are educated on how to improve distortions to reduce anxiety and depression.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Cognitive TrainingExperimental treatment 1 intervention
Group B: Enhanced Treatment as UsualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Cognitive Functioning
Neurocognitive Test Battery. Scored on a composite of various cognitive tests will indicate improved, not improved at follow-up. The composite score ranges from 0 to 50 with higher scores indicating greater improvement.
Time frame
Baseline, 3 monthsSecondary outcomes
1
Global Functioning Scale - Role and Social
Interview-based assessment of work or school functioning and of social functioning. Scores range from 0-100 with higher score indicating better functioning.
Time frame
Baseline, 3 months2
Comprehensive Assessment of At-Risk Mental States
Interview based assessment of clinical status assess change in clinical status from baseline to post - intervention. The scores range from 0-60 with higher scores indicating worse outcomes.
Time frame
Baseline, 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov