NCT06032455

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Sep 2023Sep 2027

First Submitted

Initial submission to the registry

July 25, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 13, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

July 25, 2023

Last Update Submit

April 8, 2026

Conditions

Keywords

multisystemic therapyintellectual disabilityadolescent behavioural problemsfamily functioning

Outcome Measures

Primary Outcomes (2)

  • Rule-breaking behaviour of adolescents - parents

    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.

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

  • Rule-breaking behaviour of adolescents - adolescents

    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.

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

Secondary Outcomes (14)

  • 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

  • Parenting stress

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

  • Out-of-home placement

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

  • Delinquency

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

  • +9 more secondary outcomes

Other Outcomes (6)

  • Family and treatment characteristics

    Start of MST(-ID) treatment (T0)

  • Intellectual functioning

    Start of MST(-ID) treatment (T0)

  • Adaptive functioning

    Start of MST(-ID) treatment (T0)

  • +3 more other outcomes

Study Arms (2)

Families receiving standard MST

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

Behavioral: Multisystemic therapy

Families receiving MST-ID

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

Behavioral: Multisystemic therapy - intellectual disabilities

Interventions

Multisystemic therapy - intellectual disabilities (MST-ID) is a specialisation of standard MST (see above), tailored to the needs and skill deficits of families in which the adolescent and/or parent(s) has/have a known or suspected ID. In MST-ID, among others, simplified language and visual support are used, and extra attention is paid to the generalisation of what has been learned in the treatment sessions.

Also known as: MST-ID
Families receiving MST-ID

Multisystemic Therapy (MST) is an intensive, evidence-based treatment aimed at preventing out-of-home placement of adolescents with severe behavioural problems. The intervention is home-based and focuses not only on the adolescent, but also on the various systems surrounding the adolescent, such as the family, neighbourhood, school, and friends. MST helps parents increase their parenting competencies such as parental monitoring and find (more) social support in their environment. MST also helps adolescents improve their relationship with their parents, school participation, and social activities, and promotes contact with pro-social peers. These goals are achieved by working together with key figures in the family's environment. MST treatment duration is three to five months. In MST, a family can contact a therapist 24/7.

Also known as: MST
Families receiving standard MST

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

De Viersprong

Halsteren, Netherlands

RECRUITING

Koraal

Sittard, Netherlands

RECRUITING

Stichting Prisma

Waalwijk, Netherlands

RECRUITING

Pactum

Zetten, Netherlands

RECRUITING

Related Publications (9)

  • Emerson E, Einfeld S, Stancliffe RJ. Predictors of the persistence of conduct difficulties in children with cognitive delay. J Child Psychol Psychiatry. 2011 Nov;52(11):1184-94. doi: 10.1111/j.1469-7610.2011.02413.x. Epub 2011 Apr 19.

    PMID: 21501168BACKGROUND
  • Blankestein A, van der Rijken R, Eeren HV, Lange A, Scholte R, Moonen X, De Vuyst K, Leunissen J, Didden R. Evaluating the effects of multisystemic therapy for adolescents with intellectual disabilities and antisocial or delinquent behaviour and their parents. J Appl Res Intellect Disabil. 2019 May;32(3):575-590. doi: 10.1111/jar.12551. Epub 2019 Jan 8.

    PMID: 30620111BACKGROUND
  • Blankestein A, Lange A, van der Rijken R, Scholte R, Moonen X, Didden R. Brief report: Follow-up outcomes of multisystemic therapy for adolescents with an intellectual disability and the relation with parental intellectual disability. J Appl Res Intellect Disabil. 2020 May;33(3):618-624. doi: 10.1111/jar.12691. Epub 2019 Dec 28.

    PMID: 31883357BACKGROUND
  • De Ruiter KP, Dekker MC, Douma JCH, Verhulst FC, Koot HM. Development of parent- and teacher-reported emotional and behavioural problems in young people with intellectual disabilities: Does level of intellectual disability matter? J Appl Res Intellect Disabil. 2008; 21(1): 70-80.

    BACKGROUND
  • Wallander JL, Dekker MC, Koot HM. Psychopathology in children and adolescents with intellectual disability: Measurement, prevalence, course, and risk. International Review of Research in Mental Retardation. 2003; 26: 93-134.

    BACKGROUND
  • Blankestein A, Van der Rijken R, De Vuyst K, De Bruijn J, Moonen X, Leunissen J, Didden R. Multisysteemtherapie voor jongeren met een licht verstandelijke beperking en hun ouders: Een onderzoek naar de effectiviteit van een ambulante systeemgerichte interventie. Directieve Therapie. 2016; 36(3): 204-219. Dutch.

    BACKGROUND
  • Dekker MC. Short Review: Psychopathology in young people with mild ID or borderline intellectual functioning: Research findings from representative (clinical) samples & future needs. Academische Werkplaats Kajak. 2019.

    BACKGROUND
  • Henggeler SW, Schoenwald SK, Borduin CM, Rowland MD, Cunningham PB. Multisystemic therapy for antisocial behavior in children and adolescents. 2nd ed. New York: The Guilford Press; 2009.

    BACKGROUND
  • Kaal HL, Overvest N, Boertjes MJ. Beperkt in de keten: Mensen met een licht verstandelijke beperking in de strafrechtsketen [People with mild intellectual disability in the justice system]. 2nd ed. Amsterdam: Boom Lemma; 2014.

    BACKGROUND

MeSH Terms

Conditions

Mental DisordersIntellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental Disorders

Study Officials

  • Dineke Feenstra, PhD

    De Viersprong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annemarieke Blankestein, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

September 13, 2023

Study Start

September 4, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations