The Effectiveness of Blended Forensic Ambulant Systemic Therapy (NCT05606978) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Effectiveness of Blended Forensic Ambulant Systemic Therapy
Netherlands200 participantsStarted 2022-11-14
Plain-language summary
The purpose of this study is to investigate whether blended Forensic Ambulant Systemic Therapy (FASTb) is equally effective as regular FAST (FASTr).
Who can participate
Age range
12 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Aggression and Delinquency assessed by the Youth Self Report (YSR)
Timeframe: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
2
Change in Aggression and Delinquency assessed with the Child Behavior Checklist (CBCL)
Timeframe: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
3
Change in Delinquency assessed with the Self-Report Delinquent Behavior (ZDG)
Timeframe: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
4
Percentage of Participants with Out of Home Placement assessed using File Analysis
Timeframe: T1 (baseline); T2 (post-intervention) up to 9 months
5
Percentage of Participants with Out of Home Placement assessed using an Out of Home Placement Questionnaire
Timeframe: T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
6
Change in Recidivism Risk assessed with the RAF GGZ Youth