CompletedNot Applicable

The Effectiveness of Forensic Outpatient Systemic Therapy: a Multiple Case Experimental Design

Netherlands21 participantsStarted 2023-08-25

Plain-language summary

The purpose of this study is to investigate the effectiveness and mediators of Forensic Outpatient Systemic Therapy (FAST).

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.

Exclusion criteria

. Juvenile has an estimated IQ-score of 80 or higher and/or sufficient adaptive skills to benefit from FAST;
. Juvenile is aged 12 to 21 years old at the start of the intervention;
. Juvenile exhibits externalizing behavior resulting in problems in at least two life areas (family, school, or leisure time), determined by clinical impressions based on information from intake and/or referrer information;
. Juvenile has a medium to high recidivism risk, measured by the Risk Assessment Instrument for Outpatient Forensic Mental Health Care Youth (RAF GGZ Youth);
. Presence of juvenile-caregiver relationship problems, measured by the RAF GGZ Youth;
. Juvenile has a diagnosis of a DSM-5 behavioral disorder, which is determined using a new diagnostic process or case file analysis;
. Juvenile and caregiver(s) cannot be motivated to follow treatment at the treatment site after multiple attempts by the therapist;
. Juvenile resides with their caregiver(s) or is expected to return to residing with their caregiver(s) within the first two months of FAST.

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

Change in Aggression assessed by the Aggressive Behavior scale of the Youth Self Report (YSR)

Timeframe: Twice a week during phase A, up to 5 weeks; every other week during phase B, up to 8 months; weekly during phase C, 6 weeks

Change in Aggression assessed by the Aggressive Behavior scale of the Child Behavior Checklist (CBCL)

Timeframe: Twice a week during phase A, up to 5 weeks; every other week during phase B, up to 8 months; weekly during phase C, 6 weeks

Change in Client Formulated Subgoals assessed by the FAST Goal list

Timeframe: Twice a week during phase A, up to 5 weeks; every other week during phase B, up to 8 months; weekly during phase C, 6 weeks

Change in Juvenile-Caregiver Conflict assessed by the Network of Relationship Inventory (NRI)

Timeframe: T1 (baseline); twice a week during phase A, up to 5 weeks; every other week during phase B, up to 8 months; T2 (post-intervention) up to 9 months; weekly during phase C, 6 weeks

Change in Caregiver Responsiveness assessed by the the Responsiveness Scale of the Nijmeegse Parenting Questionnaire (NPQ)

Timeframe: T1 (baseline); twice a week during phase A, up to 5 weeks; every other week during phase B, up to 8 months; T2 (post-intervention) up to 9 months; weekly during phase C, 6 weeks

Trial details

NCT IDNCT06032520

SponsorUtrecht University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-18

View on ClinicalTrials.gov More Conduct Disorder trials

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.

Exclusion criteria

. Juvenile has an estimated IQ-score of 80 or higher and/or sufficient adaptive skills to benefit from FAST;
. Juvenile is aged 12 to 21 years old at the start of the intervention;
. Juvenile exhibits externalizing behavior resulting in problems in at least two life areas (family, school, or leisure time), determined by clinical impressions based on information from intake and/or referrer information;
. Juvenile has a medium to high recidivism risk, measured by the Risk Assessment Instrument for Outpatient Forensic Mental Health Care Youth (RAF GGZ Youth);
. Presence of juvenile-caregiver relationship problems, measured by the RAF GGZ Youth;
. Juvenile has a diagnosis of a DSM-5 behavioral disorder, which is determined using a new diagnostic process or case file analysis;
. Juvenile and caregiver(s) cannot be motivated to follow treatment at the treatment site after multiple attempts by the therapist;
. Juvenile resides with their caregiver(s) or is expected to return to residing with their caregiver(s) within the first two months of FAST.