Clinical trial NCT06032455: Effectiveness of Multisystemic Therapy for Adolescents From Families With Intellectual Disabilities
Official title: The Effectiveness of Multisystemic Therapy for Adolescents With Severe Behavioural Problems From Families With Intellectual Disabilities: A Mixed-Method Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Behavioural Problems
Keywords: multisystemic therapy
intellectual disability
adolescent behavioural problems
family functioning
Lead sponsor: De Viersprong
Sponsor class: OTHER
Collaborators: name: Stichting tot Steun
name: Koraal
name: Prisma
name: MST-Netherlands/Belgium
name: Radboud University Medical Center
name: Pactum
First posted: 2023-09-13
Enrollment: 470
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population consists of adolescents and their parent(s) with a known or suspected ID referred to MST-ID at one of three Dutch mental health care organisations (de Viersprong, Koraal, and Prisma) or to standard MST at one of two Dutch mental health care organisations (de Viersprong and Pactum).

Brief summary: 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.

Detailed description: 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:

Quantitatively, the Propensity Score (PS) method is used to balance treatment groups and, combined with Multilevel Modelling (MLM), to estimate treatment effect over time. Qualitatively, the experiences of approximately 10 adolescents and/or parents are centralised. The qualitative research methods will be decided upon in a participatory manner with respondents (examples of potential research methods are interviews, focus group discussions, or photo elicitation).

Study population:

Adolescents (10-19y) with severe behavioural problems or delinquent behaviours, and their parent(s) receiving MST(-ID) treatment. All research participants must be from families where either the adolescent and/or parent(s) has/have ID.

Intervention:

Following standard referral procedures, families were either referred to standard MST or MST-ID treatment (i.e., non-randomly). Both standard MST and MST-ID are intensive, home-based treatments with 3-5 home visits per week, targeting the severe behavioural problems of adolescents across multiple life domains. MST-ID is tailored to the needs and skill deficits of adolescents and/or parents with ID. Concretely, more attention is paid to how therapists create engagement, implement interventions, and realise support from informal supports, in a tailored, developmentally appropriate, and simplified manner (meaning in a more structured way and using accessible language, among others), when compared to standard MST.

Research questions:

Building on the objectives, the following research questions were formulated:

Primary research questions:

1. Is MST-ID superior, when compared to standard MST, in reducing rule-breaking behaviour of adolescents, according to parents?
2. Is MST-ID superior, when compared to standard MST, in reducing rule-breaking behaviour of adolescents, according to adolescents?

   Secondary research questions:
3. Is MST-ID superior, when compared to standard MST, in reducing externalising and internalising behavioural problems of adolescents, according to parents?
4. Is MST-ID superior, when compared to standard MST, in reducing externalising and internalising behavioural problems of adolescents, according to adolescents?
5. Is MST-ID superior, when compared to standard MST, in reducing parenting stress?
6. Is MST-ID superior, when compared to standard MST, in preventing short and long term out-of-home placement, delinquency, truancy or joblessness, and addictions of adolescents?
7. Is MST-ID superior, when compared to standard MST, in realising improvements on family's social networks?
8. Is MST-ID superior, when compared to standard MST, in improving the instrumental outcome parenting skills?
9. Is MST-ID superior, when compared to standard MST, in improving the instrumental outcome family relations?
10. Is MST-ID superior, when compared to standard MST, in improving the instrumental outcome social support?
11. Is MST-ID superior, when compared to standard MST, in improving the instrumental outcome adolescent success in an educational or vocational setting?
12. Is MST-ID superior, when compared to standard MST, in improving the instrumental outcome adolescent involvement with pro-social peers?
13. Is MST-ID superior, when compared to standard MST, in improving the instrumental outcome change in adolescent problem behaviour?
14. What are the experiences of adolescents and/or parents receiving MST-ID treatment?
15. Do effects across subgroups of adolescents and/or parents with ID differ?

MST-ID is expected to be superior in achieving the aforementioned outcomes (#1-13) when compared to standard MST. Research questions #14-15 will be assessed exploratively, therefore no hypotheses have been formulated.

Eligibility criteria: 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.

Exclusion Criteria 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.

Primary outcomes:
measure: Rule-breaking behaviour of adolescents - parents
timeFrame: Start of MST(-ID) treatment (T0) until 18-month follow up (T4)
measure: Rule-breaking behaviour of adolescents - adolescents
timeFrame: Start (T0) and end (T1) of MST(-ID) treatment, an average of 4 months in between
Secondary outcomes:
measure: Externalising and internalising behavioural problems of adolescents - parents
timeFrame: Start of MST(-ID) treatment (T0) until 18-month follow up (T4)
measure: Externalising and internalising behavioural problems of adolescents - adolescents
timeFrame: Start (T0) and end (T1) of MST(-ID) treatment, an average of 4 months in between
measure: Parenting stress
timeFrame: Start of MST(-ID) treatment (T0) until 18-month follow up (T4)
measure: Out-of-home placement
timeFrame: Start of MST(-ID) treatment (T0) until 18-month follow up (T4)
measure: Delinquency
timeFrame: Start of MST(-ID) treatment (T0) until 18-month follow up (T4)
measure: School going or work
timeFrame: Start of MST(-ID) treatment (T0) until 18-month follow up (T4)
measure: Addictions
timeFrame: Start of MST(-ID) treatment (T0) until 18-month follow up (T4)
measure: Social network
timeFrame: Start of MST(-ID) treatment (T0) until 18-month follow up (T4)
measure: IO Percentage of families with improved parenting skills
timeFrame: End of MST(-ID) treatment, an average of 4 months after start of treatment
measure: IO Percentage of families with improved family relations
timeFrame: End of MST(-ID) treatment, an average of 4 months after start of treatment
measure: IO Percentage of families with improved social support
timeFrame: End of MST(-ID) treatment, an average of 4 months after start of treatment
measure: IO Percentage of families with adolescent success in an educational or vocational setting
timeFrame: End of MST(-ID) treatment, an average of 4 months after start of treatment
measure: IO Percentage of families with adolescent involvement with pro-social peers
timeFrame: End of MST(-ID) treatment, an average of 4 months after start of treatment
measure: IO Percentage of families with change in adolescent problem behaviour
timeFrame: End of MST(-ID) treatment, an average of 4 months after start of treatment
Other outcomes:
measure: Family and treatment characteristics
timeFrame: Start of MST(-ID) treatment (T0)
measure: Intellectual functioning
timeFrame: Start of MST(-ID) treatment (T0)
measure: Adaptive functioning
timeFrame: Start of MST(-ID) treatment (T0)
measure: Treatment fidelity
timeFrame: Monthly throughout MST(-ID) treatment, an average of 4 months
measure: Subgroups of ID families
timeFrame: Start of MST(-ID) treatment (T0)
measure: Experiences of families receiving MST-ID
timeFrame: Through study completion, an average of 1 year
Locations:
city: Halsteren
country: Netherlands
facility: De Viersprong
city: Sittard
country: Netherlands
facility: Koraal
city: Waalwijk
country: Netherlands
facility: Stichting Prisma
city: Zetten
country: Netherlands
facility: Pactum
Study officials:
affiliation: De Viersprong
name: Dineke Feenstra, PhD
role: PRINCIPAL_INVESTIGATOR
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