<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01713088</url>
  </required_header>
  <id_info>
    <org_study_id>MSTBC2012</org_study_id>
    <secondary_id>MSTBC2012</secondary_id>
    <nct_id>NCT01713088</nct_id>
  </id_info>
  <brief_title>A Trial of Multisystemic Therapy in UK a Statutory Therapeutic Intervention for Young Offenders</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Brandon Centre, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Brandon Centre, London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate whether Multisystemic Therapy (MST) is more effective in reducing youth offending&#xD;
      and out-of-home placement in a large, ethnically diverse, urban U.K. sample than an equally&#xD;
      comprehensive management protocol; to determine whether MST leads to broader improvements in&#xD;
      youth sociality and in mediators believed to be responsible for change in MST.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2003</start_date>
  <completion_date type="Anticipated">February 2014</completion_date>
  <primary_completion_date type="Actual">September 2010</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in offending behavior based on police records of criminal offenses committed</measure>
    <time_frame>baseline and 6, 12, 18, 24, 30 and 36 months post randomization</time_frame>
    <description>The number of records of offending behavior (count data) was obtained, and 6-month periods free of any offending behavior were also recorded (binary data). Records were obtained from the National Young Offender Information System (YOIS) database. YOIS records detail offence information, court appearances, criminal orders, police custody records, and arrest rates.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>self- and parent-rated symptoms of antisocial behavior, delinquency-linked cognitions, personality functioning, and parenting variables</measure>
    <time_frame>baseline and 6 months after randomization</time_frame>
    <description>Antisocial behavior was assessed using the Self-Report of Youth Behavior (SRYB), a brief, valid measure of the prevalence and incidence in pre-adolescent and adolescent children of delinquent behavior such as vandalism, theft, burglary, and fraud; and the delinquency and aggression subscales of the Youth Self-Report (YSR) and the parent-completed Child Behavior Checklist (CBCL).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Antisocial Beliefs and Attitudes Scale (ABAS)</measure>
    <time_frame>Baseline and 6 months after randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Antisocial Process Screening Device (APSD)</measure>
    <time_frame>Baseline and 6 months after randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Measure of youth's involvement with delinquent peers (IDP)</measure>
    <time_frame>Baseline and 6 months after randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Measure of Positive Parenting and Disciplinary Practices, Parent Monitoring and Supervision</measure>
    <time_frame>Baseline and 6 months after randomization</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Participants Are Male and Female Adolescents 13-16 Years at Risk for Continuing to Commit Criminal Offences.</condition>
  <arm_group>
    <arm_group_label>Multisystemic therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MST is a family- and community-based intervention that establishes close contact with families to understand and deal with the factors that cause the young person's antisocial behaviour. The intervention targets the individual's adjustment, family relationships, school functioning and peer group affiliations. Therapists help caretakers develop skills to intervene and operate changes in important domains such as young person's individual adjustment, their family relationships, school functioning, and peer group affiliations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>YOT (usual services)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>YOT intervention consisted of services currently available to young offenders in accordance with the Youth Justice Board National Standards.These services included supporting the young person to re-engage with education, with substance misuse problems and anger management; training them in social problem-solving skills; and programs to decrease vehicle-crime, violent-offending and knife crime. The treatments were delivered by professional social workers, specialist therapists or probation officers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multisystemic therapy</intervention_name>
    <arm_group_label>Multisystemic therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>YOT (usual services)</intervention_name>
    <arm_group_label>YOT (usual services)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 13 and 16 years;&#xD;
&#xD;
          -  living in the home of and being brought up by a parent or principal caretaker;&#xD;
&#xD;
          -  on a court referral order for treatment or a supervision order of at least 3 months'&#xD;
             duration, or, following imprisonment, on license in the community for at least 6&#xD;
             months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  being a sex offender;&#xD;
&#xD;
          -  presented only with substance misuse;&#xD;
&#xD;
          -  diagnosed with a psychotic illness or posed a risk to trial personnel;&#xD;
&#xD;
          -  incompatible agency involvement (e.g., ongoing care proceedings).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Brandon Centre</name>
      <address>
        <city>London</city>
        <zip>NW5 3LG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.brandon-centre.org.uk/</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Butler S, Baruch G, Hickey N, Fonagy P. A randomized controlled trial of multisystemic therapy and a statutory therapeutic intervention for young offenders. J Am Acad Child Adolesc Psychiatry. 2011 Dec;50(12):1220-35.e2. doi: 10.1016/j.jaac.2011.09.017. Epub 2011 Nov 6. Erratum In: J Am Acad Child Adolesc Psychiatry. 2012 Mar;51(3):337.</citation>
    <PMID>22115143</PMID>
  </results_reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>October 23, 2012</last_update_submitted>
  <last_update_submitted_qc>October 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>multisystemic therapy, RCT, young offenders, U.K.</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01713088
org study id: MSTBC2012
secondary id: MSTBC2012
nct id: NCT01713088
lead sponsor: 
has dmc: Yes
To evaluate whether Multisystemic Therapy (MST) is more effective in reducing youth offending
      and out-of-home placement in a large, ethnically diverse, urban U.K. sample than an equally
      comprehensive management protocol; to determine whether MST leads to broader improvements in
      youth sociality and in mediators believed to be responsible for change in MST.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change in offending behavior based on police records of criminal offenses committed
time frame: baseline and 6, 12, 18, 24, 30 and 36 months post randomization
description: The number of records of offending behavior (count data) was obtained, and 6-month periods free of any offending behavior were also recorded (binary data). Records were obtained from the National Young Offender Information System (YOIS) database. YOIS records detail offence information, court appearances, criminal orders, police custody records, and arrest rates.
measure: self- and parent-rated symptoms of antisocial behavior, delinquency-linked cognitions, personality functioning, and parenting variables
time frame: baseline and 6 months after randomization
description: Antisocial behavior was assessed using the Self-Report of Youth Behavior (SRYB), a brief, valid measure of the prevalence and incidence in pre-adolescent and adolescent children of delinquent behavior such as vandalism, theft, burglary, and fraud; and the delinquency and aggression subscales of the Youth Self-Report (YSR) and the parent-completed Child Behavior Checklist (CBCL).
measure: Antisocial Beliefs and Attitudes Scale (ABAS)
time frame: Baseline and 6 months after randomization
measure: Antisocial Process Screening Device (APSD)
time frame: Baseline and 6 months after randomization
measure: Measure of youth's involvement with delinquent peers (IDP)
time frame: Baseline and 6 months after randomization
measure: Measure of Positive Parenting and Disciplinary Practices, Parent Monitoring and Supervision
time frame: Baseline and 6 months after randomization
arm group label: Multisystemic therapy
arm group type: Experimental
description: MST is a family- and community-based intervention that establishes close contact with families to understand and deal with the factors that cause the young person's antisocial behaviour. The intervention targets the individual's adjustment, family relationships, school functioning and peer group affiliations. Therapists help caretakers develop skills to intervene and operate changes in important domains such as young person's individual adjustment, their family relationships, school functioning, and peer group affiliations.
arm group label: YOT (usual services)
arm group type: Active Comparator
description: YOT intervention consisted of services currently available to young offenders in accordance with the Youth Justice Board National Standards.These services included supporting the young person to re-engage with education, with substance misuse problems and anger management; training them in social problem-solving skills; and programs to decrease vehicle-crime, violent-offending and knife crime. The treatments were delivered by professional social workers, specialist therapists or probation officers.
intervention type: Other
intervention name: Multisystemic therapy
arm group label: Multisystemic therapy
intervention type: Other
intervention name: YOT (usual services)
arm group label: YOT (usual services)
criteria: 
gender: All
minimum age: 13 Years
maximum age: 16 Years
healthy volunteers: No
facility: 
country: United Kingdom
url: http://www.brandon-centre.org.uk/
description: Related Info
citation: Butler S, Baruch G, Hickey N, Fonagy P. A randomized controlled trial of multisystemic therapy and a statutory therapeutic intervention for young offenders. J Am Acad Child Adolesc Psychiatry. 2011 Dec;50(12):1220-35.e2. doi: 10.1016/j.jaac.2011.09.017. Epub 2011 Nov 6. Erratum In: J Am Acad Child Adolesc Psychiatry. 2012 Mar;51(3):337.
PMID: 22115143
responsible party type: Sponsor