- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07487155
Unified Junction of Care, Integrated Treatments and Team Coordination for ADHD in Prison Settings With Substance Use Disorder (JUSTICE-TDAH)
August 7, 2026 updated by: University Hospital, Brest
Substance use disorders (SUD) and attention deficit disorder with or without hyperactivity (ADHD) are frequently co-morbid, particularly among people under court supervision.
The coexistence of these disorders increases the social and legal vulnerability of individuals.
Better identification of ADHD in vulnerable people with SUD is essential to improving their care.
This project aims to provide appropriate support for this at-risk population.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marie BARAIS, MD
- Phone Number: +332 98 01 64 02
- Email: marie.barais@gmail.com
Study Locations
-
-
-
Brest, France, 29200
- Recruiting
- CHU Brest
-
Contact:
- Morgane GUILLOU LANDREAT, MD
- Phone Number: 029822342348
- Email: morgane.guillou@chu-brest.fr
-
Principal Investigator:
- Morgane GUILLOU LANDREAT, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult, under the supervision of the justice system or monitored by a correctional facility
- Diagnosis of Substance Use Disorder (SUD)
- Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
- No objection from the patient
- Affiliated with a Social Security system
Exclusion Criteria:
- Severe or decompensated psychiatric disorders
- Severe cognitive impairment
- Lack of understanding of the French language
- Refusal to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Workshops
Workshops with a small group of patients.
|
Assess the 5 workshops, co-constructed by the scientific committee and thanks to feedback from the qualitative study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
80% of patients participated in the workshops
Time Frame: From enrollment to the end of wordshop at 6 months
|
The primary outcome measure is the acceptability of the program to participants in the pilot workshops, gathered through:
|
From enrollment to the end of wordshop at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SF-12 quality of life
Time Frame: From enrollment to the end of wordshop at 6 months
|
The secondary outcome measure will be measured by the SF-12 quality of life, before and after the 5 workshops.
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life.
|
From enrollment to the end of wordshop at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Morgane GUILLOU-LANDREAT, MD, CHU Brest
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 3, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Study Registration Dates
First Submitted
March 12, 2026
First Submitted That Met QC Criteria
March 17, 2026
First Posted (Actual)
March 23, 2026
Study Record Updates
Last Update Posted (Actual)
August 11, 2026
Last Update Submitted That Met QC Criteria
August 7, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29BRC25.0324 - JUSTICE-TDAH
- IDRCB (Other Identifier: 2025-A02589-40)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient.
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of BrestUH.
Requestors will be required to sign and complete a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.