Clinical trial NCT05606978: The Effectiveness of Blended Forensic Ambulant Systemic Therapy
Official title: The Effectiveness of Blended Forensic Ambulant Systemic Therapy (FASTb): A Randomized Controlled Trial Comparing Blended and Regular FAST
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Conduct Disorder
Antisocial Behavior
Behavioral Disorder
Lead sponsor: Utrecht University
Sponsor class: OTHER
Collaborators: name: De Waag
First posted: 2022-11-07
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change in Aggression and Delinquency assessed by the Youth Self Report (YSR)
timeFrame: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
measure: Change in Aggression and Delinquency assessed with the Child Behavior Checklist (CBCL)
timeFrame: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
measure: Change in Delinquency assessed with the Self-Report Delinquent Behavior (ZDG)
timeFrame: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
measure: Percentage of Participants with Out of Home Placement assessed using File Analysis
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Percentage of Participants with Out of Home Placement assessed using an Out of Home Placement Questionnaire
timeFrame: T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
measure: Change in Recidivism Risk assessed with the RAF GGZ Youth
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Percentage of Participants having Recidivated
timeFrame: T4 (two years post-intervention)
Secondary outcomes:
measure: Change in Internalizing Problems assessed with the Youth Self Report (YSR)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
measure: Change in Internalizing Problems assessed with the Child Behavior Checklist (CBCL)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
measure: Change in Substance Use assessed with the Monitoring Station Substance Use
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
measure: Change in Substance Use assessed with the RAF GGZ Youth
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Substance Use assessed with the FAST Goal Lists
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Contact with Deviant Peers assessed with the Basic Questionnaire Peers (BVL)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
measure: Change in Contact with Deviant Peers assessed with the Family, Friends, & Self Scale (FFSS)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
measure: Change in Client Formulated Goals assessed by the FAST Goal Lists
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
Other outcomes:
measure: Change in Social Support assessed by the Parental Support Questionnaire (PSQ)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
measure: Change in Caregiver-Adolescent Conflict assessed by the Network of Relationship Inventory (NRI)
timeFrame: 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
measure: Change in Caregiver-Adolescent Relationship Quality assessed by the Inventory of Parent and Peer Attachment (IPPA)
timeFrame: 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
measure: Change in Caregiver-Adolescent Relationship Quality assessed by the Parental Stress Index (NOSI)
timeFrame: 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
measure: Change in Caregiver Responsiveness assessed by the Responsiveness Scale of the Nijmegen Parenting Questionnaire (NOV)
timeFrame: 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
measure: Change in Caregiver Consistency assessed by the Consistency Scale of the Nijmegen Parenting Questionnaire (NOV)
timeFrame: 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
measure: Change in Behavioral Control assessed by the Parenting Practices
timeFrame: 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
measure: Change in Discipline Practices assessed by the Parenting Dimensions Inventory (PDI)
timeFrame: 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
measure: Change in Psychological Control assessed by the Psychological Control Scale Youth Self-Report (PCS-YSR)
timeFrame: 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
measure: Change in Caregiver Competence assessed by the Parental Stress Index (NOSI)
timeFrame: 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
measure: Change in Cognitive Distortions assessed by the Shortened List Irrational Thoughts (V-LIG)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Demographics assessed by a Demographic Information Questionnaire
timeFrame: T1 (baseline)
measure: Primary Diagnosis assessed by Therapist File Search
timeFrame: T1 (baseline)
measure: Change in Personality assessed by the Inventory of Callous-Unemotional Traits (ICU)
timeFrame: T1 (baseline)
measure: Change in Personality assessed by the Antisocial Process Screening Device (APSD)
timeFrame: T1 (baseline)
measure: Treatment Integrity assessed by the FAST Evaluation Forms
timeFrame: T2 (post-intervention) up to 9 months from baseline
measure: Treatment Duration and Intensity assessed by a Treatment Duration and Intensity Questionnaire
timeFrame: T2 (post-intervention) up to 9 months from baseline
measure: Perceived Treatment Effectiveness assessed by a Perceived Effectiveness Questionnaire
timeFrame: T2 (post-intervention) up to 9 months from baseline
measure: Therapist-Client Alliance assessed by the Relationship with Interventionist
timeFrame: T2 (post-intervention) up to 9 months from baseline
measure: Treatment Satisfaction assessed by the Satisfaction with Program Scale (SPS)
timeFrame: T2 (post-intervention) up to 9 months from baseline
measure: Treatment Cooperation assessed by the Cooperation Scale
timeFrame: T2 (post-intervention) up to 9 months from baseline
measure: Treatment Expectancies assessed by the Parent Expectancies for Therapy Scale (PETS)
timeFrame: T1 (baseline)
measure: Caregiver Psychopathology assessed by the RAF GGZ Youth
timeFrame: T1 (baseline)
measure: Change in Treatment Motivation assessed by the Treatment Motivation Scales for Forensic Outpatient Treatment (TMS-F)
timeFrame: T1 (baseline)
Locations:
city: Utrecht
country: Netherlands
facility: de Waag
city: Utrecht
country: Netherlands
facility: Utrecht University
Study officials:
References: