Clinical trial NCT06032520: The Effectiveness of Forensic Outpatient Systemic Therapy: a Multiple Case Experimental Design
Official title: The Effectiveness of Forensic Outpatient Systemic Therapy: a Multiple Case Experimental Design
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Conduct Disorder
Antisocial Behavior
Aggression
Behavioral Disorder
Keywords: Multiple Case Experimental Design
Forensic Outpatient Systemic Therapy
Antisocial Behavior
Aggression
Mediation
Effectiveness
Lead sponsor: Utrecht University
Sponsor class: OTHER
Collaborators: name: De Waag
First posted: 2023-09-13
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes juveniles that will receive FAST. FAST is offered by de Waag, an outpatient forensic mental health care center in the Netherlands.

Brief summary: The purpose of this study is to investigate the effectiveness and mediators of Forensic Outpatient Systemic Therapy (FAST).

Detailed description: Forensic Outpatient Systemic Therapy (in Dutch: Forensische Ambulante Systeem Therapie; FAST) is a promising treatment for juveniles showing severe antisocial behavior, including aggression, (domestic) violence, and delinquent behavior. FAST has a flexible intensity and length, addresses individual and systemic risk and protective factors, and is responsive to the abilities of the client (system), intervention characteristics all considered crucial for effective treatment. The current study will investigate whether FAST is effective in reducing aggression of the juvenile, in reaching client formulated subgoals, and in improving family functioning (i.e., reducing juvenile-caregiver conflict and increasing caregiver responsiveness). In addition, processes of change will be examined, as well as mediation by reaching client formulated subgoals and improved family functioning. A Multiple Case Experimental Design (MCED) with an ABC design will be performed (A = baseline, B = intervention, and C = follow-up). Juveniles with primary aggression and/or anger problems (N = 15) and their caregiver(s) will be recruited.

Eligibility criteria: FAST therapists determine whether clients meet inclusion and exclusion criteria of FAST during the standard intake procedure of FAST. The FAST inclusion criteria are:

1. Juvenile has an estimated IQ-score of 80 or higher and/or sufficient adaptive skills to benefit from FAST;
2. Juvenile is aged 12 to 21 years old at the start of the intervention;
3. Juvenile exhibits externalizing behavior resulting in problems in at least two life areas (family, school, or leisure time), determined by clinical impressions based on information from intake and/or referrer information;
4. Juvenile has a medium to high recidivism risk, measured by the Risk Assessment Instrument for Outpatient Forensic Mental Health Care Youth (RAF GGZ Youth);
5. Presence of juvenile-caregiver relationship problems, measured by the RAF GGZ Youth;
6. Juvenile has a diagnosis of a DSM-5 behavioral disorder, which is determined using a new diagnostic process or case file analysis;
7. Juvenile and caregiver(s) cannot be motivated to follow treatment at the treatment site after multiple attempts by the therapist;
8. Juvenile resides with their caregiver(s) or is expected to return to residing with their caregiver(s) within the first two months of FAST.

The FAST exclusion criteria are:

1. Juvenile exhibits severe psychiatric symptoms requiring admission;
2. Problem behavior of the juvenile is caused primarily by substance abuse problems and it is expected that treatment of the substance abuse problems will decrease the problem behavior;
3. The safety of the family members or therapist cannot be sufficiently guaranteed.

To be eligible for participation in this study, one modified study inclusion criterium applies, i.e., the juvenile has primary aggression and/or anger problems (approximately 80% of referred juveniles). In addition, one study exclusion criterium applies, i.e., the juvenile is in secure residential care or confined in a correctional or detention facility at start of the intervention.

Primary outcomes:
measure: Change in Aggression assessed by the Aggressive Behavior scale of the Youth Self Report (YSR)
timeFrame: Twice a week during phase A, up to 5 weeks; every other week during phase B, up to 8 months; weekly during phase C, 6 weeks
measure: Change in Aggression assessed by the Aggressive Behavior scale of the Child Behavior Checklist (CBCL)
timeFrame: Twice a week during phase A, up to 5 weeks; every other week during phase B, up to 8 months; weekly during phase C, 6 weeks
measure: Change in Client Formulated Subgoals assessed by the FAST Goal list
timeFrame: Twice a week during phase A, up to 5 weeks; every other week during phase B, up to 8 months; weekly during phase C, 6 weeks
measure: Change in Juvenile-Caregiver Conflict assessed by the Network of Relationship Inventory (NRI)
timeFrame: T1 (baseline); twice a week during phase A, up to 5 weeks; every other week during phase B, up to 8 months; T2 (post-intervention) up to 9 months; weekly during phase C, 6 weeks
measure: Change in Caregiver Responsiveness assessed by the the Responsiveness Scale of the Nijmeegse Parenting Questionnaire (NPQ)
timeFrame: T1 (baseline); twice a week during phase A, up to 5 weeks; every other week during phase B, up to 8 months; T2 (post-intervention) up to 9 months; weekly during phase C, 6 weeks
measure: Change in Additional Criminogenic Needs assessed by individualized items
timeFrame: Twice a week during phase A, up to 5 weeks; every other week during phase B, up to 8 months; weekly during phase C, 6 weeks
Secondary outcomes:
measure: Change in Externalizing Behavior assessed by the Youth Self Report (YSR)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Externalizing Behavior assessed with the Child Behavior Checklist (CBCL)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Delinquency assessed with the Self-Report Delinquent Behavior (SDB)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
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
measure: Change in Recidivism Risk assessed with the RAF GGZ Youth
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Substance Use assessed with the Peilstation Middelengebruik
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
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 list
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Contact with Deviant Peers assessed with the Basic Peer Questionnaire (BPQ)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Social Support assessed by the Parental Support Questionnaire (PSQ)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Caregiver-Adolescent Relationship Quality assessed by the Inventory of Parent and Peer Attachment (IPPA)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Caregiver-Adolescent Relationship Quality assessed by the Nijmeegse Parenting Stress Index (NPSI)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Caregiver Consistency assessed by the Consistency Scale of the Parenting Dimensions Inventory (PDI)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Behavioral Control assessed by the Parenting Practices
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Discipline Practices assessed by the Parenting Dimensions Inventory (PDI)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Psychological Control assessed by the Psychological Control Scale Youth Self-Report (PCS-YSR)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Caregiver Competence assessed by the Nijmeegse Parenting Stress Index (NPSI)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Parental Monitoring assessed by the Parental Monitoring Scale
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Change in Cognitive Distortions assessed by the Brief Irrational Thoughts Inventory (BITI)
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 Narcissism and Impulse Control scales of the Antisocial Process Screening Device (APSD)
timeFrame: T1 (baseline)
measure: Caregiver Psychopathology assessed by the RAF GGZ Youth
timeFrame: T1 (baseline)
measure: Treatment Integrity assessed by the FAST Evaluation Forms
timeFrame: T2 (post-intervention) up to 9 months from baseline
measure: Treatment Completion assessed by Therapist File Search
timeFrame: T2 (post-intervention) up to 9 months from baseline
measure: Treatment Duration assessed by Therapist File Search
timeFrame: T2 (post-intervention) up to 9 months from baseline
measure: Treatment Intensity assessed by Therapist File Search
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: Change in Treatment Motivation assessed by the Treatment Motivation Scales for Forensic Outpatient Treatment (TMS-F)
timeFrame: T1 (baseline); T2 (post-intervention) up to 9 months
measure: Treatment Expectancies assessed by the Parent Expectancies for Therapy Scale (PETS)
timeFrame: T1 (baseline)
measure: Treatment Cooperation assessed by the Cooperation Scale
timeFrame: T2 (post-intervention) up to 9 months from baseline
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: de Waag
city: Utrecht
country: Netherlands
facility: Utrecht University
Study officials:
References: