The Effectiveness of Blended Forensic Ambulant Systemic Therapy (FASTb)

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

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

Study Overview

• Status: Recruiting
• Conditions: Conduct Disorder; Behavioral Disorder; Antisocial Behavior
• Intervention / Treatment: Behavioral: FASTb; Behavioral: FASTr

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marjolein van Cappellen; Phone Number: +31621944124; Email: [email protected]
• Study Contact Backup: Name: Jessica Asscher; Phone Number: +31624584734; Email: [email protected]

Study Locations

• Netherlands
  • Utrecht, Netherlands
    • Not yet recruiting
    • de Waag
    • Contact: Larissa Hoogsteder; Phone Number: +31302720685; Email: [email protected]
  • Utrecht, Netherlands
    • Recruiting
    • Utrecht University
    • Contact: Jessica Asscher; Phone Number: +31624584734; Email: [email protected]
    • Contact: Marjolein van Cappellen; Phone Number: +31638710840; Email: [email protected]
    • Sub-Investigator: Hanneke Creemers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Social Support assessed by the Parental Support Questionnaire (PSQ)	The PSQ is a caregiver self-reported instrument and contains 15 items. Possible scores range from 0 (no) to 1 (yes), and 1 (unsatisfied) to 5 (satisfied).	T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
Change in Caregiver-Adolescent Conflict assessed by the Network of Relationship Inventory (NRI)	The NRI is a juvenile and caregiver self-reported instrument. The NRI contains six items with possible scores ranging from 1 (little to not) to 5 (the most). For the monthly assessment, a shortened version of the NRI will be administered.	T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
Change in Caregiver-Adolescent Relationship Quality assessed by the Inventory of Parent and Peer Attachment (IPPA)	The IPPA is a juvenile self-reported instrument and contains 12 items per caregiver. Possible scores range from 1 (almost never) to 4 (almost always). For the monthly assessment, a shortened version of the IPPA will be administered.	T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
Change in Caregiver-Adolescent Relationship Quality assessed by the Parental Stress Index (NOSI)	The Parental Stress Index [Nijmeegse Ouderlijke Stress Index; NOSI] is a caregiver self-reported instrument and contains nine items. Possible scores range from 1 (not applicable at all) to 6 (completely applicable). For the monthly assessment, a shortened version of the NOSI will be administered.	T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
Change in Caregiver Responsiveness assessed by the Responsiveness Scale of the Nijmegen Parenting Questionnaire (NOV)	The Nijmegen Parenting Questionnaire [Nijmeegse Opvoedingsvragenlijst; NOV] is a juvenile and caregiver self-reported instrument. The Responsiveness scale contains eight items. Possible scores range from 1 (completely disagree) to 6 (completely agree). For monthly assessment, a shortened version of the Responsiveness scale will be administered.	T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
Change in Caregiver Consistency assessed by the Consistency Scale of the Nijmegen Parenting Questionnaire (NOV)	The Nijmegen Parenting Questionnaire [Nijmeegse Opvoedingsvragenlijst; NOV] is a juvenile and caregiver self-reported instrument. The Consistency scale contains eight items. Possible scores range from 1 (completely disagree) to 6 (completely agree). For the monthly assessment, a shortened version of the Consistency scale will be administered.	T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
Change in Behavioral Control assessed by the Parenting Practices	The Parent Practices is a juvenile and caregiver self-reported instrument and contains six items. Possible scores range from 1 (never) to 5 (always). For the monthly assessment, a shortened version of the Parenting Practices will be administered.	T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
Change in Discipline Practices assessed by the Parenting Dimensions Inventory (PDI)	The PDI is a juvenile and caregiver self-reported instrument and contains eight items. Possible scores range from 0 (very unlikely) to 3 (very likely). For the monthly assessment, a shortened version of the PDI will be administered.	T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
Change in Psychological Control assessed by the Psychological Control Scale Youth Self-Report (PCS-YSR)	The PCS-YSR is a self-reported instrument and contains eight items. Possible scores range from 1 (not applicable at all) to 5 (completely applicable). For the monthly assessment, a shortened version of the PCS-YR will be administered.	T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
Change in Caregiver Competence assessed by the Parental Stress Index (NOSI)	The Parental Stress Index [Nijmeegse Ouderlijke Stress Index; NOSI] is a caregiver self-reported instrument and contains 15 items. Possible scores range from 1 (completely disagree) to 6 (completely agree). For the monthly assessment, a shortened version of the NOSI will be administered.	T1 (baseline); monthly from baseline to post intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
Change in Cognitive Distortions assessed by the Shortened List Irrational Thoughts (V-LIG)	The Shortened List Irrational Thoughts [Verkorte Lijst Irrationele Gedachten; V-LIG] is a self-reported instrument and contains 18 items. Possible scores range from 1 (completely disagree) to 6 (completely agree).	T1 (baseline); T2 (post-intervention) up to 9 months
Demographics assessed by a Demographic Information Questionnaire	The Demographic information questionnaire contains items about gender, age, and occupation. The questionnaire contains nine items for juveniles, 19 for caregivers, and eight for therapists.	T1 (baseline)
Primary Diagnosis assessed by Therapist File Search	The therapist file contains the primary diagnosis of the juvenile.	T1 (baseline)
Change in Personality assessed by the Inventory of Callous-Unemotional Traits (ICU)	The ICU is reported by juveniles, caregivers, and therapists and contains 24 items. Possible scores range from 1 (completely untrue) to 4 (always true).	T1 (baseline)
Change in Personality assessed by the Antisocial Process Screening Device (APSD)	The APSD is reported by juveniles, caregivers, and therapists and contains 12items for juveniles and 16 items for caregivers and therapists. Possible scoresrange from 1 (completely true) to 4 (always true).	T1 (baseline)
Treatment Integrity assessed by the FAST Evaluation Forms	The FAST evaluation forms are filled in as part of the standard FAST procedure. Possible scores range from 0 (no) to 1 (yes), and 1 (very bad, never) to 10 (very good, always).	T2 (post-intervention) up to 9 months from baseline
Treatment Duration and Intensity assessed by a Treatment Duration and Intensity Questionnaire	The treatment duration and intensity questionnaire is reported on by the therapist an contains two items. The questionnaire is rated in weeks and average hours per week.	T2 (post-intervention) up to 9 months from baseline
Perceived Treatment Effectiveness assessed by a Perceived Effectiveness Questionnaire	The perceived effectiveness questionnaire is reported on by the therapist and contains one item. Possible scores range from 1 (sometimes effective) to 4 (almost always effective).	T2 (post-intervention) up to 9 months from baseline
Therapist-Client Alliance assessed by the Relationship with Interventionist	The Relationship with Interventionist is a juvenile and caregiver self-reported instrument and contains 12 items. Possible scores range from 1 (completely disagree) to 6 (completely agree).	T2 (post-intervention) up to 9 months from baseline
Treatment Satisfaction assessed by the Satisfaction with Program Scale (SPS)	The SPS is a juvenile and caregiver self-reported instrument and contains 10 items. Possible scores range from 1 (completely disagree) to 6 (completely agree).	T2 (post-intervention) up to 9 months from baseline
Treatment Cooperation assessed by the Cooperation Scale	The Cooperation Scale is reported on by juveniles, caregivers, and therapists and contains five items. Possible scores range from 1 (completely disagree) to 6 (completely agree).	T2 (post-intervention) up to 9 months from baseline
Treatment Expectancies assessed by the Parent Expectancies for Therapy Scale (PETS)	The PETS is a caregiver self-reported instrument and contains seven items. Possible scores range from 1 (completely disagree) to 5 (completely agree).	T1 (baseline)
Caregiver Psychopathology assessed by the RAF GGZ Youth	The RAF GGZ Youth is an extensive risk assessment instrument and includes items measuring caregiver psychopathology. The RAF GGZ Youth is filled in by the therapist as part of the standard FAST procedure. Possible scores range from 0 (problems not present) to 2 (problems definitely present).	T1 (baseline)
Change in Treatment Motivation assessed by the Treatment Motivation Scales for Forensic Outpatient Treatment (TMS-F)	The TMS-F is reported on by juveniles and caregivers and contains 16 items. Possible scores range from 1 (completely disagree) to 5 (completely agree).	T1 (baseline)

Collaborators and Investigators

• Sponsor: Utrecht University
• Collaborators: de Waag

Publications and helpful links

Helpful Links

• FAST Intervention Description

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Anticipated): February 1, 2027
• Study Completion (Anticipated): December 1, 2028

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Antisocial Personality Disorder; Conduct Disorder
• Other Study ID Numbers: 60-63600-98-1138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The details on which parts of the data will be shared still have to be discussed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No