- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05606978
The Effectiveness of Blended Forensic Ambulant Systemic Therapy (FASTb)
January 17, 2023 updated by: Marjolein van Cappellen, Utrecht University
The Effectiveness of Blended Forensic Ambulant Systemic Therapy (FASTb): A Randomized Controlled Trial Comparing Blended and Regular FAST
The purpose of this study is to investigate whether blended Forensic Ambulant Systemic Therapy (FASTb) is equally effective as regular FAST (FASTr).
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Forensic Ambulant Systemic Therapy (FAST) is a promising treatment for juveniles aged 12-21 showing antisocial behavior and conduct disorders.
Next to regular FAST (FASTr), a blended version was developed (FASTb), in which face-to-face contact is replaced by minimally 50% online contact over the duration of intervention, consisting of video-calls and eHealth modules.
The primary aim of the current study is to investigate whether FASTb is equally effective as FASTr.
All clients (and their caregivers) who meet the inclusion and eligibility criteria and who signed informed consent will be assigned to either the FASTr or FASTb condition.
Randomization will be done on the family level and will not depend on therapist or treatment site.
Study Type
Interventional
Enrollment (Anticipated)
200
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: Marjolein van Cappellen
- Phone Number: +31621944124
- Email: s.m.vancappellen@uu.nl
Study Contact Backup
- Name: Jessica Asscher
- Phone Number: +31624584734
- Email: j.j.asscher@uu.nl
Study Locations
-
Netherlands
-
-
Utrecht, Netherlands
- Not yet recruiting
- de Waag
-
Contact:
- Larissa Hoogsteder
- Phone Number: +31302720685
- Email: lhoogsteder@dewaagnederland.nl
-
Utrecht, Netherlands
- Recruiting
- Utrecht University
-
Contact:
- Jessica Asscher
- Phone Number: +31624584734
- Email: j.j.asscher@uu.nl
-
Contact:
- Marjolein van Cappellen
- Phone Number: +31638710840
- Email: s.m.vancappellen@uu.nl
-
Sub-Investigator:
- Hanneke Creemers
-
-
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
12 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Every juvenile and caregiver who meets the FAST inclusion criteria is considered for the study. FAST therapists determine whether clients meet the inclusion criteria during the standard FAST intake procedure. The inclusion criteria are:
- Juvenile has an estimated IQ-score of 80 or higher and/or sufficient adaptive skills to benefit from the intervention. The estimated IQ-score is measured using the Screener voor intelligentie en licht verstandelijke beperking (SCIL). The score on the SCIL determiners whether an IQ-test and/or a measurement of adaptive skills using the ADAPT is necessary;
- Juvenile is aged 12-21 years old at intervention start;
- Juvenile exhibits externalizing behavior that results in problems in at least two areas of life (family, school, leisure time), determined by referrer information and/or intake;
- Juvenile has a medium to high recidivism risk, measured by the Risicotaxatie-instrument voor de Ambulante Forensische GGZ Jeugd (RAF GGZ Jeugd) and/or the Landelijk Instrumentarium Jeugdstrafrechtketen (LIJ);
- Presence of juvenile-caregiver relationship problems, as measured by the RAF GGZ Jeugd;
- Juvenile has a diagnosis of a DSM-5 behavioral disorder, which is determined using case file analysis or a new diagnostic process;
- Caregiver(s) and juvenile cannot be motivated to follow treatment at the outpatient clinic;
- Juvenile and caregiver(s) have sufficient Dutch language skills, as estimated by the FAST therapist team;
- Treatment can be offered in either a voluntary or mandatory framework;
- Juvenile resides with their caregiver(s) or is expected to return to residing with caregiver(s) within the first two months of intervention.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Clients meet the FAST exclusion criteria, which are:
- Juvenile exhibits severe psychiatric symptoms requiring admission;
- Problem behavior of the juvenile is caused by primary substance abuse problems;
- Caregiver(s) refuse structurally to participate in treatment
- The safety of the therapist or family members cannot be guaranteed sufficiently;
- Clients do not have an electronic device or suitable internet connection to receive blended care;
- Clients have insufficient digital literacy to receive blended care;
- Families need a translator to receive the intervention.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FASTb
Participants receive FAST blended (FASTb): a combination of face-to-face and online therapy
|
FAST blended
|
Active Comparator: FASTr
Participants receive FAST regular (FASTr): face-to-face therapy
|
FAST regular
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Aggression and Delinquency assessed by the Youth Self Report (YSR)
Time Frame: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The YSR is a self-reported instrument.
The Externalizing scale contains 30 items assessing aggression and delinquency.
Possible scores range from 0 (never) to 2 (often).
For the monthly assessment, a shortened version of the YSR Externalizing scale will be administered.
|
T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Aggression and Delinquency assessed with the Child Behavior Checklist (CBCL)
Time Frame: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The CBCL is a caregiver-reported instrument.
The Externalizing scale contains 36 items assessing aggression and delinquency.
Possible scores range from 0 (never) to 2 (often).
For the monthly assessment, a shortened version of the CBCL Externalizing scale will be administered.
|
T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Delinquency assessed with the Self-Report Delinquent Behavior (ZDG)
Time Frame: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The Self-report Delinquent Behavior [Zelfrapportage Delinquent Gedrag; ZDG] is a self-reported instrument, assessing how many times the juvenile has done certain (rule-breaking) things in the past year.
The ZDG contains 30 items.
For the monthly assessment, a shortened version of the ZDG will be administered.
|
T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Percentage of Participants with Out of Home Placement assessed using File Analysis
Time Frame: T1 (baseline); T2 (post-intervention) up to 9 months
|
A participant is viewed as being placed out of home when they do not reside with their primary family, either temporarily or permanently, and either voluntarily or involuntarily.
Out of home placement is registered by therapists during treatment as part of the standard FAST procedure.
|
T1 (baseline); T2 (post-intervention) up to 9 months
|
Percentage of Participants with Out of Home Placement assessed using an Out of Home Placement Questionnaire
Time Frame: T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
A participant is viewed as being placed out of home when they do not reside with their primary family, either temporarily or permanently, and either voluntarily or involuntarily.
Out of home placement will be assessed using a questionnaire measuring living situation, which is filled in by juveniles and caregivers.
The questionnaire contains one item assessing where the juvenile lives most days of the week.
|
T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Recidivism Risk assessed with the RAF GGZ Youth
Time Frame: T1 (baseline); T2 (post-intervention) up to 9 months
|
The RAF GGZ Youth is an extensive risk assessment instrument and includes items measuring recidivism risk.
The RAF GGZ Youth is filled in by the therapist as part of the standard FAST procedure.
Possible scores range from 1 (low) to 5 (high).
|
T1 (baseline); T2 (post-intervention) up to 9 months
|
Percentage of Participants having Recidivated
Time Frame: T4 (two years post-intervention)
|
Recidivism is defined as a conviction, which is coded from official judicial records.
|
T4 (two years post-intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Internalizing Problems assessed with the Youth Self Report (YSR)
Time Frame: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The YSR is a self-reported instrument.
The Internalizing scale contains 31 items, with possible scores ranging from 0 (never) to 2 (often).
|
T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Internalizing Problems assessed with the Child Behavior Checklist (CBCL)
Time Frame: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The CBCL is a caregiver-reported instrument.
The Internalizing scale contains 32 items, with possible scores ranging from 0 (never) to 2 (often).
|
T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Substance Use assessed with the Monitoring Station Substance Use
Time Frame: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Monitoring Station Substance Use [Peilstation Middelengebruik] is a self-reported instrument.
It contains five items assessing frequency and intensity of substance use.
|
T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Substance Use assessed with the RAF GGZ Youth
Time Frame: T1 (baseline); T2 (post-intervention) up to 9 months
|
The RAF GGZ Youth is an extensive risk assessment instrument and includes items measuring substance use.
The RAF GGZ Youth is filled in by the therapist as part of the standard FAST procedure.
|
T1 (baseline); T2 (post-intervention) up to 9 months
|
Change in Substance Use assessed with the FAST Goal Lists
Time Frame: T1 (baseline); T2 (post-intervention) up to 9 months
|
The FAST Goals Lists are filled in by juveniles, caregivers, and therapists as part of the standard FAST-procedure, and assess the achievement of FAST goals in the past two months.
The list includes 1 item on change in substance use.
Possible scores range from 1 (not true at all) to 10 (absolutely true).
|
T1 (baseline); T2 (post-intervention) up to 9 months
|
Change in Contact with Deviant Peers assessed with the Basic Questionnaire Peers (BVL)
Time Frame: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The Basic Questionnaire Peers [Basisvragenlijst Leeftijdsgenoten; BVL] is a self-reported instrument with 13 items.
Possible scores differ per question, for instance measuring amount of friends, or 0 (never) to 4 (5 times or more).
|
T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Contact with Deviant Peers assessed with the Family, Friends, & Self Scale (FFSS)
Time Frame: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The FFSS is a self-reported instrument and contains 16 items.
Possible scores range from 1 (none) to 5 (almost all of them).
|
T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Client Formulated Goals assessed by the FAST Goal Lists
Time Frame: T1 (baseline); T2 (post-intervention) up to 9 months
|
The FAST goal lists are filled in by juveniles, caregivers, and therapists as part of the standard FAST-procedure, and assess the achievement of FAST goals in the past two months.
Possible scores range from 1 (not true at all) to 10 (absolutely true).
|
T1 (baseline); T2 (post-intervention) up to 9 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Social Support assessed by the Parental Support Questionnaire (PSQ)
Time Frame: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The PSQ is a caregiver self-reported instrument and contains 15 items.
Possible scores range from 0 (no) to 1 (yes), and 1 (unsatisfied) to 5 (satisfied).
|
T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Caregiver-Adolescent Conflict assessed by the Network of Relationship Inventory (NRI)
Time Frame: T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The NRI is a juvenile and caregiver self-reported instrument.
The NRI contains six items with possible scores ranging from 1 (little to not) to 5 (the most).
For the monthly assessment, a shortened version of the NRI will be administered.
|
T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Caregiver-Adolescent Relationship Quality assessed by the Inventory of Parent and Peer Attachment (IPPA)
Time Frame: T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The IPPA is a juvenile self-reported instrument and contains 12 items per caregiver.
Possible scores range from 1 (almost never) to 4 (almost always).
For the monthly assessment, a shortened version of the IPPA will be administered.
|
T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Caregiver-Adolescent Relationship Quality assessed by the Parental Stress Index (NOSI)
Time Frame: T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The Parental Stress Index [Nijmeegse Ouderlijke Stress Index; NOSI] is a caregiver self-reported instrument and contains nine items.
Possible scores range from 1 (not applicable at all) to 6 (completely applicable).
For the monthly assessment, a shortened version of the NOSI will be administered.
|
T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Caregiver Responsiveness assessed by the Responsiveness Scale of the Nijmegen Parenting Questionnaire (NOV)
Time Frame: T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The Nijmegen Parenting Questionnaire [Nijmeegse Opvoedingsvragenlijst; NOV] is a juvenile and caregiver self-reported instrument.
The Responsiveness scale contains eight items.
Possible scores range from 1 (completely disagree) to 6 (completely agree).
For monthly assessment, a shortened version of the Responsiveness scale will be administered.
|
T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Caregiver Consistency assessed by the Consistency Scale of the Nijmegen Parenting Questionnaire (NOV)
Time Frame: T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The Nijmegen Parenting Questionnaire [Nijmeegse Opvoedingsvragenlijst; NOV] is a juvenile and caregiver self-reported instrument.
The Consistency scale contains eight items.
Possible scores range from 1 (completely disagree) to 6 (completely agree).
For the monthly assessment, a shortened version of the Consistency scale will be administered.
|
T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Behavioral Control assessed by the Parenting Practices
Time Frame: T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The Parent Practices is a juvenile and caregiver self-reported instrument and contains six items.
Possible scores range from 1 (never) to 5 (always).
For the monthly assessment, a shortened version of the Parenting Practices will be administered.
|
T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Discipline Practices assessed by the Parenting Dimensions Inventory (PDI)
Time Frame: T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The PDI is a juvenile and caregiver self-reported instrument and contains eight items.
Possible scores range from 0 (very unlikely) to 3 (very likely).
For the monthly assessment, a shortened version of the PDI will be administered.
|
T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Psychological Control assessed by the Psychological Control Scale Youth Self-Report (PCS-YSR)
Time Frame: T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The PCS-YSR is a self-reported instrument and contains eight items.
Possible scores range from 1 (not applicable at all) to 5 (completely applicable).
For the monthly assessment, a shortened version of the PCS-YR will be administered.
|
T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Caregiver Competence assessed by the Parental Stress Index (NOSI)
Time Frame: T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
The Parental Stress Index [Nijmeegse Ouderlijke Stress Index; NOSI] is a caregiver self-reported instrument and contains 15 items.
Possible scores range from 1 (completely disagree) to 6 (completely agree).
For the monthly assessment, a shortened version of the NOSI will be administered.
|
T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
|
Change in Cognitive Distortions assessed by the Shortened List Irrational Thoughts (V-LIG)
Time Frame: T1 (baseline); T2 (post-intervention) up to 9 months
|
The Shortened List Irrational Thoughts [Verkorte Lijst Irrationele Gedachten; V-LIG] is a self-reported instrument and contains 18 items.
Possible scores range from 1 (completely disagree) to 6 (completely agree).
|
T1 (baseline); T2 (post-intervention) up to 9 months
|
Demographics assessed by a Demographic Information Questionnaire
Time Frame: T1 (baseline)
|
The Demographic information questionnaire contains items about gender, age, and occupation.
The questionnaire contains nine items for juveniles, 19 for caregivers, and eight for therapists.
|
T1 (baseline)
|
Primary Diagnosis assessed by Therapist File Search
Time Frame: T1 (baseline)
|
The therapist file contains the primary diagnosis of the juvenile.
|
T1 (baseline)
|
Change in Personality assessed by the Inventory of Callous-Unemotional Traits (ICU)
Time Frame: T1 (baseline)
|
The ICU is reported by juveniles, caregivers, and therapists and contains 24 items.
Possible scores range from 1 (completely untrue) to 4 (always true).
|
T1 (baseline)
|
Change in Personality assessed by the Antisocial Process Screening Device (APSD)
Time Frame: T1 (baseline)
|
The APSD is reported by juveniles, caregivers, and therapists and contains 12items for juveniles and 16 items for caregivers and therapists.
Possible scoresrange from 1 (completely true) to 4 (always true).
|
T1 (baseline)
|
Treatment Integrity assessed by the FAST Evaluation Forms
Time Frame: T2 (post-intervention) up to 9 months from baseline
|
The FAST evaluation forms are filled in as part of the standard FAST procedure.
Possible scores range from 0 (no) to 1 (yes), and 1 (very bad, never) to 10 (very good, always).
|
T2 (post-intervention) up to 9 months from baseline
|
Treatment Duration and Intensity assessed by a Treatment Duration and Intensity Questionnaire
Time Frame: T2 (post-intervention) up to 9 months from baseline
|
The treatment duration and intensity questionnaire is reported on by the therapist an contains two items.
The questionnaire is rated in weeks and average hours per week.
|
T2 (post-intervention) up to 9 months from baseline
|
Perceived Treatment Effectiveness assessed by a Perceived Effectiveness Questionnaire
Time Frame: T2 (post-intervention) up to 9 months from baseline
|
The perceived effectiveness questionnaire is reported on by the therapist and contains one item.
Possible scores range from 1 (sometimes effective) to 4 (almost always effective).
|
T2 (post-intervention) up to 9 months from baseline
|
Therapist-Client Alliance assessed by the Relationship with Interventionist
Time Frame: T2 (post-intervention) up to 9 months from baseline
|
The Relationship with Interventionist is a juvenile and caregiver self-reported instrument and contains 12 items.
Possible scores range from 1 (completely disagree) to 6 (completely agree).
|
T2 (post-intervention) up to 9 months from baseline
|
Treatment Satisfaction assessed by the Satisfaction with Program Scale (SPS)
Time Frame: T2 (post-intervention) up to 9 months from baseline
|
The SPS is a juvenile and caregiver self-reported instrument and contains 10 items.
Possible scores range from 1 (completely disagree) to 6 (completely agree).
|
T2 (post-intervention) up to 9 months from baseline
|
Treatment Cooperation assessed by the Cooperation Scale
Time Frame: T2 (post-intervention) up to 9 months from baseline
|
The Cooperation Scale is reported on by juveniles, caregivers, and therapists and contains five items.
Possible scores range from 1 (completely disagree) to 6 (completely agree).
|
T2 (post-intervention) up to 9 months from baseline
|
Treatment Expectancies assessed by the Parent Expectancies for Therapy Scale (PETS)
Time Frame: T1 (baseline)
|
The PETS is a caregiver self-reported instrument and contains seven items.
Possible scores range from 1 (completely disagree) to 5 (completely agree).
|
T1 (baseline)
|
Caregiver Psychopathology assessed by the RAF GGZ Youth
Time Frame: T1 (baseline)
|
The RAF GGZ Youth is an extensive risk assessment instrument and includes items measuring caregiver psychopathology.
The RAF GGZ Youth is filled in by the therapist as part of the standard FAST procedure.
Possible scores range from 0 (problems not present) to 2 (problems definitely present).
|
T1 (baseline)
|
Change in Treatment Motivation assessed by the Treatment Motivation Scales for Forensic Outpatient Treatment (TMS-F)
Time Frame: T1 (baseline)
|
The TMS-F is reported on by juveniles and caregivers and contains 16 items.
Possible scores range from 1 (completely disagree) to 5 (completely agree).
|
T1 (baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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)
November 14, 2022
Primary Completion (Anticipated)
February 1, 2027
Study Completion (Anticipated)
December 1, 2028
Study Registration Dates
First Submitted
October 25, 2022
First Submitted That Met QC Criteria
November 1, 2022
First Posted (Actual)
November 7, 2022
Study Record Updates
Last Update Posted (Actual)
January 18, 2023
Last Update Submitted That Met QC Criteria
January 17, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60-63600-98-1138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
The details on which parts of the data will be shared still have to be discussed.
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.
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