Investigating a blended therapy for antisocial behavior in youth

The Effectiveness of Blended Forensic Ambulant Systemic Therapy (FASTb): A Randomized Controlled Trial Comparing Blended and Regular FAST

This study is testing if a new blended therapy that combines online and in-person support can help young people with conduct disorders and antisocial behavior just as well as traditional therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 12 Years to 21 Years
• Sex: All
• Sponsor: Utrecht University (Academic / other)
• Locations: 2 sites (Utrecht and 1 other locations)
• Trial ID: NCT05606978 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of Blended Forensic Ambulant Systemic Therapy (FASTb) compared to regular Forensic Ambulant Systemic Therapy (FASTr) for juveniles aged 12-21 exhibiting conduct disorders and antisocial behavior. The FASTb approach incorporates at least 50% online contact through video calls and eHealth modules, while FASTr relies on traditional face-to-face interactions. Participants and their caregivers will be randomly assigned to either treatment condition, with eligibility determined during the standard FAST intake procedure. The study seeks to determine if the blended approach is as effective as the conventional method.

Who should consider this trial

Good fit: Ideal candidates are juveniles aged 12-21 with an estimated IQ of 80 or higher who exhibit externalizing behaviors affecting multiple life areas.

Not a fit: Patients who do not meet the inclusion criteria or have lower IQ scores may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a more accessible and flexible treatment option for young individuals with antisocial behavior.

How similar studies have performed: Previous studies on blended therapeutic approaches have shown promise, suggesting potential for success in this novel application.

Eligibility criteria

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:

1. 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;
2. Juvenile is aged 12-21 years old at intervention start;
3. 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;
4. 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);
5. Presence of juvenile-caregiver relationship problems, as measured by the RAF GGZ Jeugd;
6. Juvenile has a diagnosis of a DSM-5 behavioral disorder, which is determined using case file analysis or a new diagnostic process;
7. Caregiver(s) and juvenile cannot be motivated to follow treatment at the outpatient clinic;
8. Juvenile and caregiver(s) have sufficient Dutch language skills, as estimated by the FAST therapist team;
9. Treatment can be offered in either a voluntary or mandatory framework;
10. 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:

1. Clients meet the FAST exclusion criteria, which are:

   1. Juvenile exhibits severe psychiatric symptoms requiring admission;
   2. Problem behavior of the juvenile is caused by primary substance abuse problems;
   3. Caregiver(s) refuse structurally to participate in treatment
   4. The safety of the therapist or family members cannot be guaranteed sufficiently;
2. Clients do not have an electronic device or suitable internet connection to receive blended care;
3. Clients have insufficient digital literacy to receive blended care;
4. Families need a translator to receive the intervention.

Where this trial is running

Utrecht and 1 other locations

• de Waag — Utrecht, Netherlands (Not_yet_recruiting)
• Utrecht University — Utrecht, Netherlands (Recruiting)

Study contacts

• Study coordinator: Marjolein van Cappellen

Conditions Conduct Disorder; Antisocial Behavior; Behavioral Disorder