跳至主要内容
临床试验/NCT06032455
NCT06032455招募中不适用

The Effectiveness of Multisystemic Therapy for Adolescents With Severe Behavioural Problems From Families With Intellectual Disabilities: A Mixed-Method Study

De Viersprong4 个研究点 分布在 1 个国家目标入组 470 人开始时间: 2023年9月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
De Viersprong
入组人数
470
试验地点
4
主要终点
Rule-breaking behaviour of adolescents - parents

研究概览

简要总结

The goal of this observational study is to determine the effectiveness of a specialisation of multisystemic therapy (MST) for adolescents with severe behavioural problems from families with an intellectual disability (ID; MST-ID).

To achieve this goal, a mixed method study design is used. To this end, a quantitative and a qualitatively primary research question are formulated:

  • Is MST-ID superior, when compared to standard MST, in reducing rule-breaking behaviour of adolescents (quantitative)?
  • What are the experiences of adolescents and/or parents receiving MST-ID treatment (qualitative)?

Participants will be asked to complete two screeners (questionnaires delivered as a verbal interview) with a total duration of approximately 30 minutes. Other data will be collected through Routine Outcome Monitoring questionnaires that are part of standard MST procedures. To this end, five 'time points' have been identified: T0 (start of MST[-ID] treatment), T1 (end of MST[-ID] treatment), T2 (follow-up 6 month after MST[-ID] treatment), T3 (follow-up 12 month after MST[-ID] treatment), and T4 (follow-up 18 month after MST[-ID] treatment). The qualitative method used to gain insight into families' experiences is determined in consultation with the families.

To assess the effectiveness of MST-ID, its treatment outcomes will be compared to standard MST treatment outcomes of families with ID.

详细描述

Background of the study:

Over the years, a large body of research has shown that adolescents with intellectual disability are 3-4 times more likely to develop severe behaviour problems than adolescents without intellectual disability. Families in which adolescents and/or one or both parent(s) have an intellectual disability (from now on, families with ID) often deal with complex problems, putting the adolescent at an increased risk of out-of-home placement. Multisystemic therapy (MST) is an intensive home-based treatment, effective in reducing severe behaviour problems and preventing the out-of-home placement of adolescents. A specialisation of MST has been developed for families with ID: MST-ID. In MST-ID, among other alterations, simplified language and visual support is used, sessions are more structured and more time is scheduled for practicing exercises, and extra attention is paid to the generalisation of what has been learned in the sessions (with the aim of attaining long-term outcomes). Pilot studies show that when compared to standard MST, MST-ID shows similar or better treatment outcomes in families with adolescents with ID. Meanwhile, MST-ID has been disseminated more widely and the target population extended by including families in which only the parent(s) have an ID.

Objective of the study:

The aim of this study is to investigate the effectiveness of MST-ID for adolescents with severe behavioural problems from families with an intellectual disability (ID), compared to standard MST. It is hypothesised that MST-ID is more effective - in terms of fewer behavioural problems, more adolescents living at home, being in school/work, no new police contacts, less parenting stress - than standard MST. Treatment outcomes are considered both quantitatively and qualitatively.

Study design:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
10 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Referral Criteria:
  • Known or suspected ID of the referred adolescent and/or their parent(s);
  • Educational level of the referred adolescent and/or highest attained diploma of their parent(s) is indicative of potential ID.
  • Inclusion Criteria Study Sample:
  • Adolescent must be 10 to 19 years old at the start of treatment;
  • Adolescent presents with severe behavioural problems in at least two life areas;
  • Adolescent lives with a family or there is a family the adolescent can live with, in which parent(s) have parental custody for a longer period of time;
  • Parent(s) consent(s) and is/are willing to engage in treatment to prevent an out-of-home placement of the adolescent;
  • Adolescent and/or parent(s) have a known or suspected intellectual disability (operationalised as an intelligence quotient [IQ] score of between 50-85 and additional deficits in adaptive functioning)
  • Adolescent and/or parent(s) have sufficient knowledge of the Dutch language (as assessed by a clinician and/or researcher) in order to understand and answer the various (self-report) questionnaires.

排除标准

  • Study Participation:
  • Adolescent lives independently;
  • Adolescent presents with severe problematic sexual behaviours, without presenting with other severe behavioural problems;
  • Adolescent presents suicidal, psychotic, or homicidal requiring specialised treatment (such as a crisis placement in a residential facility);
  • Adolescent has a severe Autism Spectrum Disorder (level 2-3 according to the Diagnostic and Statistical Manual of Mental Disorders [DSM-V] criteria) or a severe ID (IQ score <50);
  • Adolescent has internalising psychiatric problems which are the primary reason for referral, or has serious psychiatric problems (similar to #3 as well as for example eating disorder.

研究组 & 干预措施

Families receiving standard MST

Families in which the adolescent and/or parent(s) has/have an ID receiving standard MST treatment

干预措施: Multisystemic therapy (Behavioral)

Families receiving MST-ID

Families in which the adolescent and/or parent(s) has/have an ID receiving MST-ID treatment

干预措施: Multisystemic therapy - intellectual disabilities (Behavioral)

结局指标

主要结局

Rule-breaking behaviour of adolescents - parents

时间窗: Start of MST(-ID) treatment (T0) until 18-month follow up (T4)

Rule-breaking behaviour of adolescents according to parents will be assessed using the Child Behavior Check List (CBCL). The CBCL consists of 118 questions rated on a 3-point scale from 0 (absent) to 2 (occurs often). Higher scores indicate that adolescents experience more problems.

Rule-breaking behaviour of adolescents - adolescents

时间窗: Start (T0) and end (T1) of MST(-ID) treatment, an average of 4 months in between

Rule-breaking behaviour of adolescents according to parents will be assessed using the Youth Self Report (YSR). The YSR consists of 112 questions rated on a 3-point scale from 0 (absent) to 2 (occurs often). Higher scores indicate that adolescents experience more problems.

次要结局

  • Externalising and internalising behavioural problems of adolescents - parents(Start of MST(-ID) treatment (T0) until 18-month follow up (T4))
  • Externalising and internalising behavioural problems of adolescents - adolescents(Start (T0) and end (T1) of MST(-ID) treatment, an average of 4 months in between)
  • Delinquency(Start of MST(-ID) treatment (T0) until 18-month follow up (T4))
  • IO Percentage of families with change in adolescent problem behaviour(End of MST(-ID) treatment, an average of 4 months after start of treatment)
  • School going or work(Start of MST(-ID) treatment (T0) until 18-month follow up (T4))
  • Addictions(Start of MST(-ID) treatment (T0) until 18-month follow up (T4))
  • IO Percentage of families with improved social support(End of MST(-ID) treatment, an average of 4 months after start of treatment)
  • Out-of-home placement(Start of MST(-ID) treatment (T0) until 18-month follow up (T4))
  • IO Percentage of families with improved parenting skills(End of MST(-ID) treatment, an average of 4 months after start of treatment)
  • IO Percentage of families with improved family relations(End of MST(-ID) treatment, an average of 4 months after start of treatment)
  • Social network(Start of MST(-ID) treatment (T0) until 18-month follow up (T4))
  • IO Percentage of families with adolescent success in an educational or vocational setting(End of MST(-ID) treatment, an average of 4 months after start of treatment)
  • IO Percentage of families with adolescent involvement with pro-social peers(End of MST(-ID) treatment, an average of 4 months after start of treatment)
  • Parenting stress(Start of MST(-ID) treatment (T0) until 18-month follow up (T4))

研究者

发起方
De Viersprong
申办方类型
Other
责任方
Sponsor

研究点 (4)

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