The Effectiveness of Blended Forensic Ambulant Systemic Therapy (FASTb): A Randomized Controlled Trial Comparing Blended and Regular FAST
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Change in Aggression and Delinquency assessed by the Youth Self Report (YSR)
研究概览
简要总结
The purpose of this study is to investigate whether blended Forensic Ambulant Systemic Therapy (FASTb) is equally effective as regular FAST (FASTr).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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:
- •Clients meet the FAST
排除标准
- •, which are:
- •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.
研究组 & 干预措施
FASTb
Participants receive FAST blended (FASTb): a combination of face-to-face and online therapy
干预措施: FASTb (Behavioral)
FASTr
Participants receive FAST regular (FASTr): face-to-face therapy
干预措施: FASTr (Behavioral)
结局指标
主要结局
Change in Aggression and Delinquency assessed by the Youth Self Report (YSR)
时间窗: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
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.
Percentage of Participants with Out of Home Placement assessed using File Analysis
时间窗: T1 (baseline); T2 (post-intervention) up to 9 months
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.
Change in Delinquency assessed with the Self-Report Delinquent Behavior (ZDG)
时间窗: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
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.
Percentage of Participants with Out of Home Placement assessed using an Out of Home Placement Questionnaire
时间窗: T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
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.
Change in Aggression and Delinquency assessed with the Child Behavior Checklist (CBCL)
时间窗: T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention
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.
Change in Recidivism Risk assessed with the RAF GGZ Youth
时间窗: T1 (baseline); T2 (post-intervention) up to 9 months
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).
Percentage of Participants having Recidivated
时间窗: T4 (two years post-intervention)
Recidivism is defined as a conviction, which is coded from official judicial records.
次要结局
- 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 RAF GGZ Youth(T1 (baseline); T2 (post-intervention) up to 9 months)
- 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 FAST Goal Lists(T1 (baseline); T2 (post-intervention) up to 9 months)
- Change in Contact with Deviant Peers assessed with the Basic Questionnaire Peers (BVL)(T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention)
- Change in Contact with Deviant Peers assessed with the Family, Friends, & Self Scale (FFSS)(T1 (baseline); T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention)
- Change in Client Formulated Goals assessed by the FAST Goal Lists(T1 (baseline); T2 (post-intervention) up to 9 months)
研究者
Marjolein van Cappellen
PhD candidate
Utrecht University