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Conduct DisorderFASTbNCT05606978

The Effectiveness of Blended Forensic Ambulant Systemic Therapy

A study testing FASTb and FASTr in people with Conduct Disorder and Antisocial Behavior, run by Utrecht University at 2 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 12 to 21 years
What is being tested?
FASTb and FASTr
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesNetherlands
Study dates
14 Nov 2022to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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:
  2. Juvenile exhibits severe psychiatric symptoms requiring admission;
  3. Problem behavior of the juvenile is caused by primary substance abuse problems;
  4. Caregiver(s) refuse structurally to participate in treatment
  5. The safety of the therapist or family members cannot be guaranteed sufficiently;
  6. Clients do not have an electronic device or suitable internet connection to receive blended care;
  7. Clients have insufficient digital literacy to receive blended care;
  8. Families need a translator to receive the intervention.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • de Waag

    Utrecht

  • Utrecht University

    Utrecht

Other trials in Netherlands

About this study

Official title: 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).

Read the 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.

Being tested
FASTb, FASTr
Medical subject headings
Conduct Disorder, Antisocial Personality Disorder, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FASTbBehavioural

    FAST blended

  • FASTrBehavioural

    FAST regular

Study groups in NCT05606978
Study groupRoleWhat they receive
FASTbExperimentalParticipants receive FAST blended (FASTb): a combination of face-to-face and online therapy
Receives: Behavioral: FASTb
FASTrActive comparatorParticipants receive FAST regular (FASTr): face-to-face therapy
Receives: Behavioral: FASTr

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention

  2. 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.

    Measured: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention

  3. 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.

    Measured: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention

  4. 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.

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

  5. 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.

    Measured: T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention

  6. 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).

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

  7. Percentage of Participants having Recidivated

    Recidivism is defined as a conviction, which is coded from official judicial records.

    Measured: T4 (two years post-intervention)

Secondary outcomes (8)

  1. 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).

    Measured: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention

  2. 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).

    Measured: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention

  3. 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.

    Measured: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention

  4. 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.

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

  5. 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).

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

  6. 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).

    Measured: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention

  7. 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).

    Measured: T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention

  8. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2022
  2. Study start14 Nov 2022
  3. Primary completionFeb 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05606978
Sponsor's protocol ID
60-63600-98-1138
Acronym
FASTb
Status last verified
May 2026
First submitted
25 Oct 2022
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The details on which parts of the data will be shared still have to be discussed.

Publications

  • 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.

    PubMed 37143003

Questions about this trial

What is this clinical trial studying?

A study testing FASTb and FASTr in people with Conduct Disorder and Antisocial Behavior, run by Utrecht University at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Aggression and Delinquency assessed by the Youth Self Report (YSR) (time frame: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05606978, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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