The Effectiveness of Blended Forensic Ambulant Systemic Therapy

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

Detailed Description
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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.

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

Conditions
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Conduct Disorder, Antisocial Behavior, Behavioral Disorder

Intervention / Treatment
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* Behavioral: FASTb
* Behavioral: FASTr


Participation Criteria
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Eligibility Criteria
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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: 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; Treatment can be offered in either a voluntary or mandatory framework; 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: Clients meet the FAST exclusion criteria, which are: Juvenile exhibits severe psychiatric symptoms requiring admission; Problem behavior of the juvenile is caused by primary substance abuse problems; Caregiver(s) refuse structurally to participate in treatment The safety of the therapist or family members cannot be guaranteed sufficiently; Clients do not have an electronic device or suitable internet connection to receive blended care; Clients have insufficient digital literacy to receive blended care; Families need a translator to receive the intervention.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FASTb<br>Participants receive FAST blended (FASTb): a combination of face-to-face and online therapy | Behavioral: FASTb<br>* FAST blended<br>|
| Active Comparator: FASTr<br>Participants receive FAST regular (FASTr): face-to-face therapy | Behavioral: FASTr<br>* FAST regular<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Aggression and Delinquency assessed by the Youth Self Report (YSR) | The YSR is a self-reported instrument. The Externalizing scale contains 30 items assessing aggression and delinquency. Possible scores range from 0 (never) to 2 (often). For the monthly assessment, a shortened version of the YSR Externalizing scale will be administered. | T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention | 
| Change in Aggression and Delinquency assessed with the Child Behavior Checklist (CBCL) | The CBCL is a caregiver-reported instrument. The Externalizing scale contains 36 items assessing aggression and delinquency. Possible scores range from 0 (never) to 2 (often). For the monthly assessment, a shortened version of the CBCL Externalizing scale will be administered. | T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention | 
| Change in Delinquency assessed with the Self-Report Delinquent Behavior (ZDG) | The Self-report Delinquent Behavior [Zelfrapportage Delinquent Gedrag; ZDG] is a self-reported instrument, assessing how many times the juvenile has done certain (rule-breaking) things in the past year. The ZDG contains 30 items. For the monthly assessment, a shortened version of the ZDG will be administered. | T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention | 
| Percentage of Participants with Out of Home Placement assessed using File Analysis | A participant is viewed as being placed out of home when they do not reside with their primary family, either temporarily or permanently, and either voluntarily or involuntarily. Out of home placement is registered by therapists during treatment as part of the standard FAST procedure. | 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 | A participant is viewed as being placed out of home when they do not reside with their primary family, either temporarily or permanently, and either voluntarily or involuntarily. Out of home placement will be assessed using a questionnaire measuring living situation, which is filled in by juveniles and caregivers. The questionnaire contains one item assessing where the juvenile lives most days of the week. | T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention | 
| Change in Recidivism Risk assessed with the RAF GGZ Youth | The RAF GGZ Youth is an extensive risk assessment instrument and includes items measuring recidivism risk. The RAF GGZ Youth is filled in by the therapist as part of the standard FAST procedure. Possible scores range from 1 (low) to 5 (high). | T1 (baseline); T2 (post-intervention) up to 9 months | 
| Percentage of Participants having Recidivated | Recidivism is defined as a conviction, which is coded from official judicial records. | T4 (two years post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Internalizing Problems assessed with the Youth Self Report (YSR) | The YSR is a self-reported instrument. The Internalizing scale contains 31 items, with possible scores ranging from 0 (never) to 2 (often). | T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention | 
| Change in Internalizing Problems assessed with the Child Behavior Checklist (CBCL) | The CBCL is a caregiver-reported instrument. The Internalizing scale contains 32 items, with possible scores ranging from 0 (never) to 2 (often). | T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention | 
| Change in Substance Use assessed with the Monitoring Station Substance Use | Monitoring Station Substance Use [Peilstation Middelengebruik] is a self-reported instrument. It contains five items assessing frequency and intensity of substance use. | T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention | 
| Change in Substance Use assessed with the RAF GGZ Youth | The RAF GGZ Youth is an extensive risk assessment instrument and includes items measuring substance use. The RAF GGZ Youth is filled in by the therapist as part of the standard FAST procedure. | T1 (baseline); T2 (post-intervention) up to 9 months | 
| Change in Substance Use assessed with the FAST Goal Lists | The FAST Goals Lists are filled in by juveniles, caregivers, and therapists as part of the standard FAST-procedure, and assess the achievement of FAST goals in the past two months. The list includes 1 item on change in substance use. Possible scores range from 1 (not true at all) to 10 (absolutely true). | T1 (baseline); T2 (post-intervention) up to 9 months | 
| Change in Contact with Deviant Peers assessed with the Basic Questionnaire Peers (BVL) | The Basic Questionnaire Peers [Basisvragenlijst Leeftijdsgenoten; BVL] is a self-reported instrument with 13 items. Possible scores differ per question, for instance measuring amount of friends, or 0 (never) to 4 (5 times or more). | T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention | 
| Change in Contact with Deviant Peers assessed with the Family, Friends, & Self Scale (FFSS) | The FFSS is a self-reported instrument and contains 16 items. Possible scores range from 1 (none) to 5 (almost all of them). | T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention | 
| Change in Client Formulated Goals assessed by the FAST Goal Lists | The FAST goal lists are filled in by juveniles, caregivers, and therapists as part of the standard FAST-procedure, and assess the achievement of FAST goals in the past two months. Possible scores range from 1 (not true at all) to 10 (absolutely true). | T1 (baseline); T2 (post-intervention) up to 9 months |