The Effectiveness of Blended Forensic Ambulant Systemic Therapy

NCT ID: NCT05606978

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Conduct Disorder Antisocial Behavior Behavioral Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FASTb

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

Group Type EXPERIMENTAL

FASTb

Intervention Type BEHAVIORAL

FAST blended

FASTr

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

Group Type ACTIVE_COMPARATOR

FASTr

Intervention Type BEHAVIORAL

FAST regular

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FASTb

FAST blended

Intervention Type BEHAVIORAL

FASTr

FAST regular

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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:

Exclusion Criteria

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

De Waag

UNKNOWN

Sponsor Role collaborator

Utrecht University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marjolein van Cappellen

PhD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

de Waag

Utrecht, , Netherlands

Site Status NOT_YET_RECRUITING

Utrecht University

Utrecht, , Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marjolein van Cappellen

Role: CONTACT

+31621944124

Jessica Asscher

Role: CONTACT

+31624584734

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Larissa Hoogsteder

Role: primary

+31302720685

Marjolein van Cappellen

Role: primary

+31638710840

Jessica Asscher

Role: backup

+31624584734

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37143003 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

60-63600-98-1138

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Multisite Prevention of Conduct Problems (Fast Track)
NCT01653535 ACTIVE_NOT_RECRUITING NA
Recovery Legal Care Clinical Trial
NCT06618794 RECRUITING NA
Pathways 2 Success
NCT06831123 RECRUITING PHASE1/PHASE2