The Effectiveness of Blended Forensic Ambulant Systemic Therapy

NCT05606978 | Recruiting

• 1 other identifier: 60-63600-98-1138
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Conduct Disorder; Antisocial Behavior; Behavioral Disorder

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (8)

• Change in Internalizing Problems assessed with the Youth Self Report (YSR)

  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)

  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

  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

  T1 (baseline); T2 (post-intervention) up to 9 months

• Change in Substance Use assessed with the FAST Goal Lists

  T1 (baseline); T2 (post-intervention) up to 9 months

Other Outcomes (24)

• Change in Social Support assessed by the Parental Support Questionnaire (PSQ)

  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)

  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)

  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

Study Arms (2)

FASTb

EXPERIMENTAL

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

Behavioral: FASTb

FASTr

ACTIVE COMPARATOR

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

Behavioral: FASTr

Interventions

FASTb BEHAVIORAL

FAST blended

FASTb

FASTr BEHAVIORAL

FAST regular

FASTr

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Utrecht University: lead
• De Waag: collaborator

Study Sites (2)

de Waag

Utrecht, Netherlands

NOT YET RECRUITING

Utrecht University

Utrecht, Netherlands

RECRUITING

Related Publications (1)

• van Cappellen SM, Creemers HE, Hoogsteder L, van Horn J, Dekovic M, Asscher JJ. The effectiveness of blended versus regular Forensic Outpatient Systemic Therapy in the treatment of juvenile antisocial behavior: a study protocol of a randomized controlled trial. BMC Psychiatry. 2023 May 4;23(1):315. doi: 10.1186/s12888-023-04831-8.

  PMID: 37143003 DERIVED

Related Links

• FAST Intervention Description

MeSH Terms

Conditions

Conduct Disorder; Antisocial Personality Disorder; Mental Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Personality Disorders

Central Study Contacts

Marjolein van Cappellen

CONTACT

+31621944124; s.m.vancappellen@uu.nl

Jessica Asscher

CONTACT

+31624584734; j.j.asscher@uu.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 7, 2022
• Study Start: November 14, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

NL (2)