NCT06032520

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

1.9 years

First QC Date

August 28, 2023

Last Update Submit

December 6, 2024

Conditions

Keywords

Multiple Case Experimental DesignForensic Outpatient Systemic TherapyAntisocial BehaviorAggressionMediationEffectiveness

Outcome Measures

Primary Outcomes (6)

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

    The YSR is a self-reported instrument. The Aggressive Behavior scale contains 19 items assessing aggression. Possible scores range from 1 (never) to 100 (always).

    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)

    The CBCL is a caregiver-reported instrument. The Aggressive Behavior scale contains 19 items assessing aggression. Possible scores range from 1 (never) to 100 (always).

    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

    The FAST Goal list is a self-report instrument for juveniles and caregivers. It contains 21 items with possible scores ranging from 0 (not true at all) to 100 (definitely true). The FAST Goal lists are used in an idiographic and client-guided approach. The first questionnaire in phase A contains the entire FAST Goal list and a follow-up question asks participants to prioritize their top three FAST goals. In the subsequent measurements, only the items measuring the three prioritized goals are administered. Added to these three items, a fourth item measures whether prioritization or goals have changed. If so, the participant is asked to state their new prioritization or goals, and the questions about the new goals are added in the subsequent measurements.

    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)

    The NRI is a self-reported instrument for juveniles and caregivers. The NRI contains six items with possible scores ranging from 1 (not at all) to 100 (the most).

    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)

    The NPQ is a self-reported instrument for juveniles and caregivers. The the Responsiveness Scale contains eight items with possible scores ranging from 1 (completely disagree) to 100 (completely agree).

    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 Additional Criminogenic Needs assessed by individualized items

    If severe truancy, substance use, contact with deviant peers, or delinquent behavior are reported at T1 but not prioritized in the top three goals, single items will be administered on these problems as well.

    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

Secondary Outcomes (33)

  • Change in Externalizing Behavior assessed by the Youth Self Report (YSR)

    T1 (baseline); T2 (post-intervention) up to 9 months

  • Change in Externalizing Behavior assessed with the Child Behavior Checklist (CBCL)

    T1 (baseline); T2 (post-intervention) up to 9 months

  • Change in Delinquency assessed with the Self-Report Delinquent Behavior (SDB)

    T1 (baseline); T2 (post-intervention) up to 9 months

  • Percentage of Participants with Out of Home Placement assessed using File Analysis

    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

    T2 (post-intervention) up to 9 months

  • +28 more secondary outcomes

Study Arms (1)

Forensic Outpatient Systemic Therapy (FAST)

FAST is a promising treatment for juveniles showing severe antisocial behavior, including aggression, (domestic) violence, and delinquent behavior. FAST has a flexible intensity and length, addresses individual and systemic risk and protective factors, and is responsive to the abilities of the client (system), intervention characteristics all considered crucial for effective treatment.

Behavioral: FAST

Interventions

FASTBEHAVIORAL

FAST includes around 3 hours of face-to-face direct treatment time weekly and consists of a maximum of 10% online direct treatment time (i.e., treatment via phone, video-calling or texting). The treatment stage of FAST lasts five to nine months depending on the individual goals of the juvenile and the caregiver(s) and is followed by a period of aftercare.

Also known as: Forensic Outpatient Systemic Therapy, Forensische Ambulante Systeem Therapie
Forensic Outpatient Systemic Therapy (FAST)

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population includes juveniles that will receive FAST. FAST is offered by de Waag, an outpatient forensic mental health care center in the Netherlands.

You may not qualify if:

  • 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.
  • Juvenile exhibits severe psychiatric symptoms requiring admission;
  • Problem behavior of the juvenile is caused primarily by substance abuse problems and it is expected that treatment of the substance abuse problems will decrease the problem behavior;
  • The safety of the family members or therapist cannot be sufficiently guaranteed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

de Waag

Utrecht, Netherlands

NOT YET RECRUITING

Utrecht University

Utrecht, Netherlands

RECRUITING

Related Links

MeSH Terms

Conditions

Conduct DisorderAntisocial Personality DisorderAggressionMental DisordersNegotiating

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersPersonality DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial BehaviorCommunication

Central Study Contacts

Marjolein van Cappellen

CONTACT

Jessica Asscher

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 13, 2023

Study Start

August 25, 2023

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

The details on which parts of the data will be shared still have to be discussed.

Locations