The Effectiveness of Blended Forensic Ambulant Systemic Therapy (FASTb)

Utrecht University

Status: Enrolling

Conditions: Conduct Disorder; Antisocial Behavior; Behavioral Disorder

Treatments: Behavioral: FASTr; Behavioral: FASTb

Study type: Interventional

Funder types: Other

Identifiers

NCT05606978

60-63600-98-1138

Details and patient eligibility

About

The purpose of this study is to investigate whether blended Forensic Ambulant Systemic Therapy (FASTb) is equally effective as regular FAST (FASTr).

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

FASTb

Experimental group

Description:

Participants receive FAST blended (FASTb): a combination of face-to-face and online therapy

Treatment:

Behavioral: FASTb

FASTr

Active Comparator group

Description:

Participants receive FAST regular (FASTr): face-to-face therapy

Treatment:

Behavioral: FASTr