[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518585":3},{"organization":4,"outcomesModule":7,"designInfo":83,"detailedDescription":87,"studyPopulation":88,"armGroups":89,"interventions":100,"overallOfficials":114,"centralContacts":118,"locations":124,"responsibleParty":177,"collaborators":179,"id":191,"slug":84,"hasResults":192,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":84,"eligibilityCriteria":196,"healthyVolunteers":192,"sex":197,"minAge":198,"maxAge":199,"enrollmentInfo":200,"targetDuration":84,"studyType":203,"phases":84,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":126,"whyStopped":84,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},{"fullName":5,"class":6},"De Viersprong","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":61},[9,13],{"measure":10,"description":11,"timeFrame":12},"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)",{"measure":14,"description":15,"timeFrame":16},"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",[18,21,24,27,30,33,36,39,42,46,49,52,55,58],{"measure":19,"description":20,"timeFrame":12},"Externalising and internalising behavioural problems of adolescents - parents","Externalising and internalising behavioural problems of adolescents 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.",{"measure":22,"description":23,"timeFrame":16},"Externalising and internalising behavioural problems of adolescents - adolescents","Externalising and internalising behavioural problems of adolescents according to adolescents 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.",{"measure":25,"description":26,"timeFrame":12},"Parenting stress","Parenting stress will be assessed using the Parenting Stress Questionnaire (PSQ), which is the English version of the Dutch Opvoedingsbelasting Vragenlijst (OBVL). The PSQ consists of 34 questions rated on a 4-point scale from 1 (not true) to 4 (very true). Higher scores indicate more parenting stress.",{"measure":28,"description":29,"timeFrame":12},"Out-of-home placement","Out-of-home placement of adolescents will be assessed using the Social Demographic Information 3.0 questionnaire (SDI 3.0).",{"measure":31,"description":32,"timeFrame":12},"Delinquency","Delinquency of adolescents is operationalized as police contact and will be assessed using the SDI 3.0.",{"measure":34,"description":35,"timeFrame":12},"School going or work","The adolescent's school going or work is operationalised as \"school going that meets the expectations of the school or public education law officer or work that meets the expectations of caregivers and the referring agent\" and will be assessed using the SDI 3.0.",{"measure":37,"description":38,"timeFrame":12},"Addictions","Addictions of adolescents are operationalised as \"adolescent drug misuse\u002Fabuse, screen or game dependency that has resulted in addiction, and\u002For other addictions\" and will be assessed using the SDI 3.0.",{"measure":40,"description":41,"timeFrame":12},"Social network","Social network is operationalised as \"forms of social network available to a family and number of supports (read: individuals) that are available to the family\" and will be assessed using the SDI 3.0.",{"measure":43,"description":44,"timeFrame":45},"IO Percentage of families with improved parenting skills","MST's so called \"instrumental outcomes\" (IOs) identify skills which are instrumental to achieving positive treatment outcomes and are reported by therapists. The first IO assesses whether or not families show improved parenting skills, answered 'yes' or 'no'.","End of MST(-ID) treatment, an average of 4 months after start of treatment",{"measure":47,"description":48,"timeFrame":45},"IO Percentage of families with improved family relations","MST's so called \"instrumental outcomes\" (IOs) identify skills which are instrumental to achieving positive treatment outcomes and are reported by therapists. The second IO assesses whether or not families show improved family relations, answered 'yes' or 'no'.",{"measure":50,"description":51,"timeFrame":45},"IO Percentage of families with improved social support","MST's so called \"instrumental outcomes\" (IOs) identify skills which are instrumental to achieving positive treatment outcomes and are reported by therapists. The third IO assesses whether or not families show improved social support, answered 'yes' or 'no'.",{"measure":53,"description":54,"timeFrame":45},"IO Percentage of families with adolescent success in an educational or vocational setting","MST's so called \"instrumental outcomes\" (IOs) identify skills which are instrumental to achieving positive treatment outcomes and are reported by therapists. The fourth IO assesses whether or not the adolescent obtained success in an educational or vocational setting, answered 'yes' or 'no'.",{"measure":56,"description":57,"timeFrame":45},"IO Percentage of families with adolescent involvement with pro-social peers","MST's so called \"instrumental outcomes\" (IOs) identify skills which are instrumental to achieving positive treatment outcomes and are reported by therapists. The fifth IO assesses whether or not the adolescent is involved with pro-social peers, answered 'yes' or 'no'.",{"measure":59,"description":60,"timeFrame":45},"IO Percentage of families with change in adolescent problem behaviour","MST's so called \"instrumental outcomes\" (IOs) identify skills which are instrumental to achieving positive treatment outcomes and are reported by therapists. The sixth IO assesses whether or not the adolescent obtained changes in problem behaviour that were sustained for 3-4 weeks, answered 'yes' or 'no'.",[62,66,69,72,76,79],{"measure":63,"description":64,"timeFrame":65},"Family and treatment characteristics","Characteristics of families that are gathered are previous treatment, referral stream and the following:\n\nAdolescent: age, gender identity, cultural background, prior residential placement, living situation, level of education Primary caregiver: level of education, employment status, partner, experienced financial stress, experienced living situation stress","Start of MST(-ID) treatment (T0)",{"measure":67,"description":68,"timeFrame":65},"Intellectual functioning","Intellectual functioning will be assessed using the Dutch Screener for Intelligence and Learning Disabilities (SCIL). The SCIL consists of 14 questions that result in a total SCIL score that can range from 0 to 28. A total SCIL score of 19 and below indicates the presence of intellectual disabilities.",{"measure":70,"description":71,"timeFrame":65},"Adaptive functioning","Adaptive functioning will be assessed using the Dutch Screener for Adaptive Functioning and Learning Disabilities (SCAF). The SCAF consists of 12 questions that result in a total SCAF score that can range from 0 to 13. A higher score indicates a higher level of adaptive functioning.",{"measure":73,"description":74,"timeFrame":75},"Treatment fidelity","Treatment fidelity is measured and checked through administration of a validated questionnaire to the primary caregiver of each family (TAM-R).","Monthly throughout MST(-ID) treatment, an average of 4 months",{"measure":77,"description":78,"timeFrame":65},"Subgroups of ID families","Families included in this study are divided across three subsamples: families in which only the adolescent, only the parent(s), and both the adolescent and parent(s) have ID. This This variable will be calculated based on participants' SCIL scores.",{"measure":80,"description":81,"timeFrame":82},"Experiences of families receiving MST-ID","Experiences of families receiving MST-ID will be assessed using participatory and qualitative research methods. The aim is to recruit 10 adolescents or parents and to ask them to help identify which elements of MST-ID are most important to them, and which elements were found least and most helpful. This can lead to a better understanding of what works well and less well in MST-ID treatments. Potential qualitative research methods are focus group discussions, peer-interviewing, and photo-elicitation\u002Fphoto voice.","Through study completion, an average of 1 year",{"allocation":84,"interventionModel":84,"interventionModelDescription":84,"primaryPurpose":84,"observationalModel":85,"timePerspective":86,"maskingInfo":84},null,"CASE_CONTROL","PROSPECTIVE","Background of the study:\n\nOver 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\u002For 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.\n\nObjective of the study:\n\nThe 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\u002Fwork, no new police contacts, less parenting stress - than standard MST. Treatment outcomes are considered both quantitatively and qualitatively.\n\nStudy design:\n\nQuantitatively, 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\u002For 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).\n\nStudy population:\n\nAdolescents (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\u002For parent(s) has\u002Fhave ID.\n\nIntervention:\n\nFollowing 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\u002For 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.\n\nResearch questions:\n\nBuilding on the objectives, the following research questions were formulated:\n\nPrimary research questions:\n\n1. Is MST-ID superior, when compared to standard MST, in reducing rule-breaking behaviour of adolescents, according to parents?\n2. Is MST-ID superior, when compared to standard MST, in reducing rule-breaking behaviour of adolescents, according to adolescents?\n\n   Secondary research questions:\n3. Is MST-ID superior, when compared to standard MST, in reducing externalising and internalising behavioural problems of adolescents, according to parents?\n4. Is MST-ID superior, when compared to standard MST, in reducing externalising and internalising behavioural problems of adolescents, according to adolescents?\n5. Is MST-ID superior, when compared to standard MST, in reducing parenting stress?\n6. 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?\n7. Is MST-ID superior, when compared to standard MST, in realising improvements on family's social networks?\n8. Is MST-ID superior, when compared to standard MST, in improving the instrumental outcome parenting skills?\n9. Is MST-ID superior, when compared to standard MST, in improving the instrumental outcome family relations?\n10. Is MST-ID superior, when compared to standard MST, in improving the instrumental outcome social support?\n11. Is MST-ID superior, when compared to standard MST, in improving the instrumental outcome adolescent success in an educational or vocational setting?\n12. Is MST-ID superior, when compared to standard MST, in improving the instrumental outcome adolescent involvement with pro-social peers?\n13. Is MST-ID superior, when compared to standard MST, in improving the instrumental outcome change in adolescent problem behaviour?\n14. What are the experiences of adolescents and\u002For parents receiving MST-ID treatment?\n15. Do effects across subgroups of adolescents and\u002For parents with ID differ?\n\nMST-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.","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).",[90,95],{"label":91,"type":84,"description":92,"interventionNames":93},"Families receiving standard MST","Families in which the adolescent and\u002For parent(s) has\u002Fhave an ID receiving standard MST treatment",[94],"Behavioral: Multisystemic therapy",{"label":96,"type":84,"description":97,"interventionNames":98},"Families receiving MST-ID","Families in which the adolescent and\u002For parent(s) has\u002Fhave an ID receiving MST-ID treatment",[99],"Behavioral: Multisystemic therapy - intellectual disabilities",[101,108],{"type":102,"name":103,"description":104,"armGroupLabels":105,"otherNames":106},"BEHAVIORAL","Multisystemic therapy","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\u002F7.",[91],[107],"MST",{"type":102,"name":109,"description":110,"armGroupLabels":111,"otherNames":112},"Multisystemic therapy - intellectual disabilities","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\u002For parent(s) has\u002Fhave 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.",[96],[113],"MST-ID",[115],{"name":116,"affiliation":5,"role":117},"Dineke Feenstra, PhD","PRINCIPAL_INVESTIGATOR",[119],{"name":120,"role":121,"phone":122,"phoneExt":84,"email":123},"Annemarieke Blankestein, PhD","CONTACT","+31629392787","annemarieke.blankestein@deviersprong.nl",[125,140,152,164],{"facility":5,"status":126,"city":127,"state":84,"zip":84,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":135,"contacts":136},"RECRUITING","Halsteren","Netherlands","NL",{"type":131,"coordinates":132},"Point",[133,134],4.26785,51.52834,{"lat":134,"lon":133},[137],{"name":138,"role":121,"phone":139,"phoneExt":84,"email":84},"Dineke J Feenstra, PhD","+31887656200",{"facility":141,"status":126,"city":142,"state":84,"zip":84,"country":128,"countryCode":129,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Koraal","Sittard",{"type":131,"coordinates":144},[145,146],5.86944,50.99833,{"lat":146,"lon":145},[149],{"name":150,"role":121,"phone":151,"phoneExt":84,"email":84},"Gaby van Helvert","+31464775252",{"facility":153,"status":126,"city":154,"state":84,"zip":84,"country":128,"countryCode":129,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Stichting Prisma","Waalwijk",{"type":131,"coordinates":156},[157,158],5.07083,51.6825,{"lat":158,"lon":157},[161],{"name":162,"role":121,"phone":163,"phoneExt":84,"email":84},"Mariska Mecking","+31629547022",{"facility":165,"status":126,"city":166,"state":84,"zip":84,"country":128,"countryCode":129,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Pactum","Zetten",{"type":131,"coordinates":168},[169,170],5.71389,51.92833,{"lat":170,"lon":169},[173],{"name":174,"role":121,"phone":175,"phoneExt":84,"email":176},"Mies Geenen","+31629673556","miesgeenen@vigogroep.nl",{"type":178,"investigatorFullName":84,"investigatorTitle":84,"investigatorAffiliation":84,"oldNameTitle":84,"oldOrganization":84},"SPONSOR",[180,183,184,186,188,190],{"name":181,"class":182},"Stichting tot Steun","UNKNOWN",{"name":141,"class":6},{"name":185,"class":182},"Prisma",{"name":187,"class":182},"MST-Netherlands\u002FBelgium",{"name":189,"class":6},"Radboud University Medical Center",{"name":165,"class":182},"100518585",false,"NCT06032455","Effectiveness of Multisystemic Therapy for Adolescents From Families With Intellectual Disabilities","The Effectiveness of Multisystemic Therapy for Adolescents With Severe Behavioural Problems From Families With Intellectual Disabilities: A Mixed-Method Study","Referral Criteria:\n\n* Known or suspected ID of the referred adolescent and\u002For their parent(s);\n* Educational level of the referred adolescent and\u002For highest attained diploma of their parent(s) is indicative of potential ID.\n\nInclusion Criteria Study Sample:\n\n* Adolescent must be 10 to 19 years old at the start of treatment;\n* Adolescent presents with severe behavioural problems in at least two life areas;\n* 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;\n* Parent(s) consent(s) and is\u002Fare willing to engage in treatment to prevent an out-of-home placement of the adolescent;\n* Adolescent and\u002For 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)\n* Adolescent and\u002For parent(s) have sufficient knowledge of the Dutch language (as assessed by a clinician and\u002For researcher) in order to understand and answer the various (self-report) questionnaires.\n\nExclusion Criteria Study Participation:\n\n* Adolescent lives independently;\n* Adolescent presents with severe problematic sexual behaviours, without presenting with other severe behavioural problems;\n* Adolescent presents suicidal, psychotic, or homicidal requiring specialised treatment (such as a crisis placement in a residential facility);\n* 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 \\\u003C50);\n* 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.","ALL","10 Years","19 Years",{"count":201,"type":202},470,"ESTIMATED","OBSERVATIONAL","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).\n\nTo achieve this goal, a mixed method study design is used. To this end, a quantitative and a qualitatively primary research question are formulated:\n\n* Is MST-ID superior, when compared to standard MST, in reducing rule-breaking behaviour of adolescents (quantitative)?\n* What are the experiences of adolescents and\u002For parents receiving MST-ID treatment (qualitative)?\n\nParticipants 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.\n\nTo assess the effectiveness of MST-ID, its treatment outcomes will be compared to standard MST treatment outcomes of families with ID.",[206],"Behavioural Problems",[208,209,210,211],"multisystemic therapy","intellectual disability","adolescent behavioural problems","family functioning","2026-04-08",{"date":214,"type":215},"2026-04-13","ACTUAL",{"date":217,"type":215},"2023-09-04",{"date":219,"type":202},"2027-09",{"name":5,"class":6},4]