The Effectiveness of Blended Forensic Ambulant Systemic Therapy

Conduct Disorder Clinical Trial

— FASTb  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05606978
• Other study ID #: 60-63600-98-1138
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: December 2028

Study information

• Verified date: May 2024
• Source: Utrecht University
• Contact: Marjolein van Cappellen
• Phone: +31621944124
• Email: s.m.vancappellen[@]uu.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2028
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antisocial Behavior
• Antisocial Personality Disorder
• Behavioral Disorder
• Conduct Disorder

Intervention

Behavioral:
• FASTb
FAST blended
• FASTr
FAST regular

Locations

Country	Name	City	State
Netherlands	de Waag	Utrecht
Netherlands	Utrecht University	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Utrecht University	De Waag

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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)
Other	Primary Diagnosis assessed by Therapist File Search	The therapist file contains the primary diagnosis of the juvenile.	T1 (baseline)
Other	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)
Other	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)
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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)
Other	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)
Other	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Percentage of Participants having Recidivated	Recidivism is defined as a conviction, which is coded from official judicial records.	T4 (two years post-intervention)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   FAST Intervention Description