NCT06032455 Effectiveness of Multisystemic Therapy for Adolescents From Families With Intellectual Disabilities
| NCT ID | NCT06032455 |
| Status | Recruiting |
| Phase | — |
| Sponsor | De Viersprong |
| Condition | Behavioural Problems |
| Study Type | OBSERVATIONAL |
| Enrollment | 470 participants |
| Start Date | 2023-09-04 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 470 participants in total. It began in 2023-09-04 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Dineke Feenstra, PhD
PRINCIPAL INVESTIGATOR
De Viersprong
Frequently Asked Questions
Who can join the NCT06032455 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 19 Years, studying Behavioural Problems. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06032455 currently recruiting?
Yes, NCT06032455 is actively recruiting participants. Contact the research team at annemarieke.blankestein@deviersprong.nl for enrollment information.
Where is the NCT06032455 trial being conducted?
This trial is being conducted at Halsteren, Netherlands, Sittard, Netherlands, Waalwijk, Netherlands, Zetten, Netherlands.
Who is sponsoring the NCT06032455 clinical trial?
NCT06032455 is sponsored by De Viersprong. The principal investigator is Dineke Feenstra, PhD at De Viersprong. The trial plans to enroll 470 participants.