xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <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/NCT05965622</url>
    </required_header>
    <id_info>
      <org_study_id>NL82274.018.22</org_study_id>
      <secondary_id>S65701</secondary_id>
      <nct_id>NCT05965622</nct_id>
    </id_info>
    <brief_title>(Cost)-Effectiveness of ABFT for Suicidal Youth.</brief_title>
    <acronym>REPAIR</acronym>
    <official_title>Targeting Suicidality in Young Adults: a Randomized, Controlled Pragmatic, Multicentre Trial Evaluating the (Cost)-Effectiveness of Attachment Based Family Therapy Compared to Treatment as Usual</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>KU Leuven</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Belgium Health Care Knowledge Centre</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Young adults who attempt to kill themselves is a common and serious mental health problem&#xD;
        worldwide and certainly in Belgium and the Netherlands. Fatal suicide is the leading cause of&#xD;
        death among young adults. It has devastating consequences both for the young adults&#xD;
        themselves and for their families. It also has substantial economic costs. However, up until&#xD;
        now, there is little research on the treatment of suicidality among young adults. The current&#xD;
        psychological therapy approaches and drug treatments for young people at very high risk of&#xD;
        fatal suicide attempts have only limited success. Increasing evidence indicates the&#xD;
        importance of involving significant others in treatment and the importance of the unfulfilled&#xD;
        need for belonging and secure attachment. The WHO recommends involving significant others in&#xD;
        the treatment of suicidal young adults. However, in Belgium and the Netherlands, there is&#xD;
        little knowledge on the effectiveness of family based treatments. Attachment Based Family&#xD;
        Therapy, or ABFT, was shown to work well in several studies in the US. Also in Belgium and&#xD;
        the Netherlands, ABFT is being used to treat suicidal young adults. However, how well it&#xD;
        works compared to the current treatment and if it provides good value for money have not been&#xD;
        studied in young adults. In the proposed study the investigators will test, in a real-life&#xD;
        situation, whether ABFT works better than the current treatment and if it provides good value&#xD;
        for money. This study is a collaboration between the Netherlands and Belgium and 6 or 7 sites&#xD;
        will participate from each country. Sites can be hospitals, mental health centres, student&#xD;
        health centres or private practices. Participants (138 individuals) are young adults between&#xD;
        18 and 25 years old who have frequent thoughts about killing themselves, and who seek mental&#xD;
        health treatment. The investigators predict that, compared to current treatment, ABFT will&#xD;
        reduce suicidal thoughts and suicide attempts and that this improvement will be maintained&#xD;
        over time, and that it will be better value for money. The project will contribute to&#xD;
        improving care for suicidal young adults with high suicide risk. Results will inform clinical&#xD;
        guidelines and policymakers and improve the treatment of young adults with a high risk for&#xD;
        fatal suicide, and their families.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators conduct a randomized controlled trial to evaluate the (cost-)effectiveness&#xD;
        of ABFT compared to Treatment As Usual (TAU) on suicidality, as delivered in daily practice.&#xD;
        The hypothesis is that, compared to TAU, ABFT will lead to a stronger reduction of suicidal&#xD;
        ideation and suicidal behavior, and will be more cost-effective, will improve family&#xD;
        functioning and young adult attachment, and that this effect will hold at follow-up. The&#xD;
        primary objective is change in suicidality, that is, suicidal ideation, attempts and suicide&#xD;
        as assessed by the Suicidal Ideation Questionnaire Junior (SIQ-JR), and as reported by&#xD;
        therapists during treatment. Secondary objectives are cost-effectiveness, process, working&#xD;
        alliance and adherence during treatment, and change in young adult depressive symptoms,&#xD;
        family functioning, and young adult attachment.&#xD;
  &#xD;
        Attachment Based Family Therapy (ABFT): ABFT is a manualized treatment, that emerges from&#xD;
        interpersonal theories that suggest suicide can be precipitated, exacerbated, or buffered&#xD;
        against by the quality of family relationships. Therefore, ABFT focuses on strengthening&#xD;
        parent-child attachment bonds to create a protective and secure base for young adult&#xD;
        development. Sessions are scheduled weekly, and the intervention lasts on average 16 weeks.&#xD;
        Treatment as usual (TAU): Participants in both arms will receive TAU, in the experimental&#xD;
        condition ABFT will be delivered as an add-on. Most treatment centres' clinical practices&#xD;
        rely heavily on the use of antidepressants and/or CBT or DBT. All regular interventions are&#xD;
        allowed in TAU, except for systemic family therapy of more than 4 sessions in total. Parents&#xD;
        are allowed to be involved in the treatment, which is part of treatment as usual, and can&#xD;
        comprise for instance psycho-education or parental support or skill training.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">November 14, 2026</completion_date>
    <primary_completion_date type="Anticipated">November 15, 2025</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>
      <intervention_model_description>A randomized, controlled, pragmatic, multicentre, trial in the Netherlands and Belgium with 13 participating sites.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>Part of the research team that will collect and analyse the data are blinded.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Suicidality</measure>
      <time_frame>Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)</time_frame>
      <description>Suicidality is assessed by the SIQ-JR. (Reynolds &amp; Mazza, 1999)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Suicide ideation</measure>
      <time_frame>Measures change at: baseline, 5 months after baseline (after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)</time_frame>
      <description>Assessed with the SCID-5-S, DSM 5 diagnostic interview. Michael B.First, JBWW, Lorna Smith Benjamin, Robert L. Spitzer, 2017)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Suicide attempts</measure>
      <time_frame>Measures change at: baseline, 5 months after baseline (after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)</time_frame>
      <description>Assessed with the SCID-5-S, DSM 5 diagnostic interview. Michael B.First, JBWW, Lorna Smith Benjamin, Robert L. Spitzer, 2017)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression (DSM 5)</measure>
      <time_frame>Measures change at: baseline, 5 months after baseline (after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)</time_frame>
      <description>Assessed with the SCID-5-S, DSM 5 diagnostic interview. Michael B.First, JBWW, Lorna Smith Benjamin, Robert L. Spitzer, 2017)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depressive symptoms</measure>
      <time_frame>Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)</time_frame>
      <description>Patient Health Questionnaire (PHQ-9).(Kroenke, Spitzer &amp; Williams, 2001)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parental vision on the young adults depressive symptoms</measure>
      <time_frame>Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)</time_frame>
      <description>Parental vision on the young adults depression symptoms Clinical Depression Inventory second edition (CDI-2) (Bodden, Braet,&#xD;
  &amp; Stikkelbroek, 2016.) .</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Family functioning</measure>
      <time_frame>Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)</time_frame>
      <description>Self Report Measures of Family Functioning (SRFF). (Stark et al., 1990), both the young adult and the parents/caregiver</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Attachment</measure>
      <time_frame>Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)</time_frame>
      <description>Secure Base Script (SBS) task to asses attachment. (Waters et al., 2019; Waters &amp; Roisman, 2019)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)</time_frame>
      <description>Health-related quality of life: EQ-5D-5L (Versteegh et al., 2016)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disability</measure>
      <time_frame>Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)</time_frame>
      <description>World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). (Ustun, Kostanjsek, Chatterji &amp; Rehm, 2010)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-suicidal self-injury</measure>
      <time_frame>Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)</time_frame>
      <description>Non-suicidal self-injury questionnaire.(Buelens, T., Luyckx, K., Kiekens, G., Gandhi, A., Muehlenkamp, J. J., &amp; Claes, L. (2020).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Autonomy</measure>
      <time_frame>Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)</time_frame>
      <description>Autonomy of the young adult, as assessed by the questionnaire. My Parents and I, a combination of items of the Emotional Autonomy Scale (EAS; Steinberg &amp; Zilverberg, 1986) and the Psychological Separation Inventory (PSI; Hoffman 1984).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Entrapment</measure>
      <time_frame>Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)</time_frame>
      <description>Entrapment Short-Form Scale (E-SF; De Beurs et al., 2020). The E-SF is a 4-item questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health care and associated costs and costs from productivity loss</measure>
      <time_frame>Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)</time_frame>
      <description>Health care and associated costs and costs from productivity loss: TiC-P (Hakkaart-Van Roijen, 2002).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Childhood Trauma</measure>
      <time_frame>Baseline</time_frame>
      <description>Childhood Trauma Questionnaire (CTQ). This is a self-report 28-item questionnaire that measures 5 types of maltreatment: emotional, physical, and sexual abuse, and emotional and physical neglect.</description>
    </other_outcome>
    <other_outcome>
      <measure>Working Alliance Inventory</measure>
      <time_frame>Every 2 months during intervention starting at the first session</time_frame>
      <description>Working Alliance Inventory (WAI). Measures overall therapeutic alliance and consists of sub scales measuring (quality of therapy) tasks, goals and bonds. Admistered to young adult and the participating parent or caregiver.</description>
    </other_outcome>
    <other_outcome>
      <measure>Treatment fidelity</measure>
      <time_frame>Every 2 months during intervention starting at the first session</time_frame>
      <description>The Therapist Behavior Rating Scale-3 &amp; non-verbal contact will be assessd via videotaping by a trained researcher.</description>
    </other_outcome>
    <other_outcome>
      <measure>Therapy Procedure</measure>
      <time_frame>Every 2 months during intervention starting at the first session</time_frame>
      <description>Therapy Procedures Checklist (TPC). It assesses therapists' reports of the techniques they employ when working with child and adolescent clients, and will be used to monitor Treatment as Usual in both study arms. TPC items encompass the 3 most common therapeutic models for youth: psychodynamic, cognitive, and behavioural.</description>
    </other_outcome>
    <other_outcome>
      <measure>Demographic characteristics and other parameters</measure>
      <time_frame>Baseline</time_frame>
      <description>Demographic characteristics: age, marital status, gender, ethnicity, level of education, medication use, substance use (smoking, alcohol, drugs), psychiatric history (therapy, medication, number of previous episodes, duration of episodes and treatment).</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">138</enrollment>
    <condition>Suicidal Ideation</condition>
    <arm_group>
      <arm_group_label>ABFT + TAU</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Attachment Based Family Therapy (ABFT) is a manualized treatment, that emerges from interpersonal theories that suggest suicide can be precipitated, exacerbated, or buffered against by the quality of family relationships. Parent(s)/caregiver(s) will be involved in the therapy.&#xD;
  In the experimental group, patients will receive ABFT as an add-on therapy besides treatment as usual (TAU).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TAU</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Treatment as Usual (TAU) contains all regular interventions that are currently used to treat suicidality. In the TAU group, a limited number of systemic family therapy sessions will be given (maximum 4 sessions).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Attachment Based Family Therapy (ABFT) + Treatment As Usual (TAU)</intervention_name>
      <description>Attachment Based Family Therapy (ABFT): ABFT is a manualized treatment, that emerges from interpersonal theories that suggest suicide can be precipitated, exacerbated, or buffered against by the quality of family relationships. Therefore, ABFT focuses on strengthening parent-child attachment bonds to create a protective and secure base for young adult development. Sessions are scheduled weekly, and the intervention lasts on average 16 weeks.&#xD;
  The participants in the ABFT condition will also receive treatment as usual (TAU).</description>
      <arm_group_label>ABFT + TAU</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Treatment As Usual (TAU)</intervention_name>
      <description>The participants in the treatment as usual (TAU) condition will only receive regular existing care to treat suicidality in young adults.</description>
      <arm_group_label>TAU</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged between 18 and 25.&#xD;
  &#xD;
            -  A score above 31 on the SIQ-JR (the cut-off for suicidality).&#xD;
  &#xD;
            -  Have at least one primary parent or caregiver that participates in the assessment and&#xD;
               treatment. This could be a biological parent, stepparent, grandparent, other relative,&#xD;
               or a foster parent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other DSM-5 disorders: modest/severe substance dependency, severe conduct disorder,&#xD;
               evidence of psychotic features or prior psychosis (assessed with the SCID-5-S).&#xD;
  &#xD;
            -  Severe cognitive impairment (e.g., mental retardation, severe developmental disorders)&#xD;
               as evidenced by educational records, parental report and/or clinical impression.&#xD;
  &#xD;
            -  Other circumstances that might affect participation (e.g., severe medical disorder,&#xD;
               relocation).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nadia van der Spek, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Academic Medical Center (AMC)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Claudi Bockting, professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Academic Medical Center (AMC)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Guy Bosmans, Professor</last_name>
      <role>Study Director</role>
      <affiliation>KU Leuven</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Claudi L.H. Bockting, Professor</last_name>
      <phone>+3120-8913600</phone>
      <email>c.l.bockting@amsterdamumc.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nadia Van Der Spek, PhD</last_name>
      <phone>+31624138237</phone>
      <email>n.vanderspek@amsterdamumc.nl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>GGZ OostBrabant</name>
        <address>
          <city>Oss</city>
          <state>Noord Holland</state>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hanneke Niels, MSc</last_name>
        <phone>+31634238923</phone>
        <email>hanneke.niels@ggzoostbrabant.nl</email>
      </contact>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
      <investigator_full_name>Claudi Bockting</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Suicidality in young adults</keyword>
    <keyword>Attachment Based Family Therapy</keyword>
    <keyword>(cost)-effectiveness</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Suicidal Ideation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05965622
  org study id: NL82274.018.22
  secondary id: S65701
  nct id: NCT05965622
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Young adults who attempt to kill themselves is a common and serious mental health problem
        worldwide and certainly in Belgium and the Netherlands. Fatal suicide is the leading cause of
        death among young adults. It has devastating consequences both for the young adults
        themselves and for their families. It also has substantial economic costs. However, up until
        now, there is little research on the treatment of suicidality among young adults. The current
        psychological therapy approaches and drug treatments for young people at very high risk of
        fatal suicide attempts have only limited success. Increasing evidence indicates the
        importance of involving significant others in treatment and the importance of the unfulfilled
        need for belonging and secure attachment. The WHO recommends involving significant others in
        the treatment of suicidal young adults. However, in Belgium and the Netherlands, there is
        little knowledge on the effectiveness of family based treatments. Attachment Based Family
        Therapy, or ABFT, was shown to work well in several studies in the US. Also in Belgium and
        the Netherlands, ABFT is being used to treat suicidal young adults. However, how well it
        works compared to the current treatment and if it provides good value for money have not been
        studied in young adults. In the proposed study the investigators will test, in a real-life
        situation, whether ABFT works better than the current treatment and if it provides good value
        for money. This study is a collaboration between the Netherlands and Belgium and 6 or 7 sites
        will participate from each country. Sites can be hospitals, mental health centres, student
        health centres or private practices. Participants (138 individuals) are young adults between
        18 and 25 years old who have frequent thoughts about killing themselves, and who seek mental
        health treatment. The investigators predict that, compared to current treatment, ABFT will
        reduce suicidal thoughts and suicide attempts and that this improvement will be maintained
        over time, and that it will be better value for money. The project will contribute to
        improving care for suicidal young adults with high suicide risk. Results will inform clinical
        guidelines and policymakers and improve the treatment of young adults with a high risk for
        fatal suicide, and their families.
  The investigators conduct a randomized controlled trial to evaluate the (cost-)effectiveness
        of ABFT compared to Treatment As Usual (TAU) on suicidality, as delivered in daily practice.
        The hypothesis is that, compared to TAU, ABFT will lead to a stronger reduction of suicidal
        ideation and suicidal behavior, and will be more cost-effective, will improve family
        functioning and young adult attachment, and that this effect will hold at follow-up. The
        primary objective is change in suicidality, that is, suicidal ideation, attempts and suicide
        as assessed by the Suicidal Ideation Questionnaire Junior (SIQ-JR), and as reported by
        therapists during treatment. Secondary objectives are cost-effectiveness, process, working
        alliance and adherence during treatment, and change in young adult depressive symptoms,
        family functioning, and young adult attachment.
  
        Attachment Based Family Therapy (ABFT): ABFT is a manualized treatment, that emerges from
        interpersonal theories that suggest suicide can be precipitated, exacerbated, or buffered
        against by the quality of family relationships. Therefore, ABFT focuses on strengthening
        parent-child attachment bonds to create a protective and secure base for young adult
        development. Sessions are scheduled weekly, and the intervention lasts on average 16 weeks.
        Treatment as usual (TAU): Participants in both arms will receive TAU, in the experimental
        condition ABFT will be delivered as an add-on. Most treatment centres' clinical practices
        rely heavily on the use of antidepressants and/or CBT or DBT. All regular interventions are
        allowed in TAU, except for systemic family therapy of more than 4 sessions in total. Parents
        are allowed to be involved in the treatment, which is part of treatment as usual, and can
        comprise for instance psycho-education or parental support or skill training.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A randomized, controlled, pragmatic, multicentre, trial in the Netherlands and Belgium with 13 participating sites.
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: Part of the research team that will collect and analyse the data are blinded.
  measure: Suicidality
  time frame: Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)
  description: Suicidality is assessed by the SIQ-JR. (Reynolds & Mazza, 1999)
  measure: Suicide ideation
  time frame: Measures change at: baseline, 5 months after baseline (after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)
  description: Assessed with the SCID-5-S, DSM 5 diagnostic interview. Michael B.First, JBWW, Lorna Smith Benjamin, Robert L. Spitzer, 2017)
  measure: Suicide attempts
  time frame: Measures change at: baseline, 5 months after baseline (after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)
  description: Assessed with the SCID-5-S, DSM 5 diagnostic interview. Michael B.First, JBWW, Lorna Smith Benjamin, Robert L. Spitzer, 2017)
  measure: Depression (DSM 5)
  time frame: Measures change at: baseline, 5 months after baseline (after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)
  description: Assessed with the SCID-5-S, DSM 5 diagnostic interview. Michael B.First, JBWW, Lorna Smith Benjamin, Robert L. Spitzer, 2017)
  measure: Depressive symptoms
  time frame: Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)
  description: Patient Health Questionnaire (PHQ-9).(Kroenke, Spitzer & Williams, 2001)
  measure: Parental vision on the young adults depressive symptoms
  time frame: Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)
  description: Parental vision on the young adults depression symptoms Clinical Depression Inventory second edition (CDI-2) (Bodden, Braet,
  & Stikkelbroek, 2016.) .
  measure: Family functioning
  time frame: Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)
  description: Self Report Measures of Family Functioning (SRFF). (Stark et al., 1990), both the young adult and the parents/caregiver
  measure: Attachment
  time frame: Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)
  description: Secure Base Script (SBS) task to asses attachment. (Waters et al., 2019; Waters & Roisman, 2019)
  measure: Health-related quality of life
  time frame: Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)
  description: Health-related quality of life: EQ-5D-5L (Versteegh et al., 2016)
  measure: Disability
  time frame: Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)
  description: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). (Ustun, Kostanjsek, Chatterji & Rehm, 2010)
  measure: Non-suicidal self-injury
  time frame: Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)
  description: Non-suicidal self-injury questionnaire.(Buelens, T., Luyckx, K., Kiekens, G., Gandhi, A., Muehlenkamp, J. J., & Claes, L. (2020).
  measure: Autonomy
  time frame: Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)
  description: Autonomy of the young adult, as assessed by the questionnaire. My Parents and I, a combination of items of the Emotional Autonomy Scale (EAS; Steinberg & Zilverberg, 1986) and the Psychological Separation Inventory (PSI; Hoffman 1984).
  measure: Entrapment
  time frame: Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)
  description: Entrapment Short-Form Scale (E-SF; De Beurs et al., 2020). The E-SF is a 4-item questionnaire.
  measure: Health care and associated costs and costs from productivity loss
  time frame: Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)
  description: Health care and associated costs and costs from productivity loss: TiC-P (Hakkaart-Van Roijen, 2002).
  measure: Childhood Trauma
  time frame: Baseline
  description: Childhood Trauma Questionnaire (CTQ). This is a self-report 28-item questionnaire that measures 5 types of maltreatment: emotional, physical, and sexual abuse, and emotional and physical neglect.
  measure: Working Alliance Inventory
  time frame: Every 2 months during intervention starting at the first session
  description: Working Alliance Inventory (WAI). Measures overall therapeutic alliance and consists of sub scales measuring (quality of therapy) tasks, goals and bonds. Admistered to young adult and the participating parent or caregiver.
  measure: Treatment fidelity
  time frame: Every 2 months during intervention starting at the first session
  description: The Therapist Behavior Rating Scale-3 & non-verbal contact will be assessd via videotaping by a trained researcher.
  measure: Therapy Procedure
  time frame: Every 2 months during intervention starting at the first session
  description: Therapy Procedures Checklist (TPC). It assesses therapists' reports of the techniques they employ when working with child and adolescent clients, and will be used to monitor Treatment as Usual in both study arms. TPC items encompass the 3 most common therapeutic models for youth: psychodynamic, cognitive, and behavioural.
  measure: Demographic characteristics and other parameters
  time frame: Baseline
  description: Demographic characteristics: age, marital status, gender, ethnicity, level of education, medication use, substance use (smoking, alcohol, drugs), psychiatric history (therapy, medication, number of previous episodes, duration of episodes and treatment).
  arm group label: ABFT + TAU
  arm group type: Experimental
  description: Attachment Based Family Therapy (ABFT) is a manualized treatment, that emerges from interpersonal theories that suggest suicide can be precipitated, exacerbated, or buffered against by the quality of family relationships. Parent(s)/caregiver(s) will be involved in the therapy.
  In the experimental group, patients will receive ABFT as an add-on therapy besides treatment as usual (TAU).
  arm group label: TAU
  arm group type: Placebo Comparator
  description: Treatment as Usual (TAU) contains all regular interventions that are currently used to treat suicidality. In the TAU group, a limited number of systemic family therapy sessions will be given (maximum 4 sessions).
  intervention type: Behavioral
  intervention name: Attachment Based Family Therapy (ABFT) + Treatment As Usual (TAU)
  description: Attachment Based Family Therapy (ABFT): ABFT is a manualized treatment, that emerges from interpersonal theories that suggest suicide can be precipitated, exacerbated, or buffered against by the quality of family relationships. Therefore, ABFT focuses on strengthening parent-child attachment bonds to create a protective and secure base for young adult development. Sessions are scheduled weekly, and the intervention lasts on average 16 weeks.
  The participants in the ABFT condition will also receive treatment as usual (TAU).
  arm group label: ABFT + TAU
  intervention type: Behavioral
  intervention name: Treatment As Usual (TAU)
  description: The participants in the treatment as usual (TAU) condition will only receive regular existing care to treat suicidality in young adults.
  arm group label: TAU
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 25 Years
  healthy volunteers: No
  last name: Nadia van der Spek, PhD
  role: Study Director
  affiliation: Academic Medical Center (AMC)
  last name: Claudi Bockting, professor
  role: Principal Investigator
  affiliation: Academic Medical Center (AMC)
  last name: Guy Bosmans, Professor
  role: Study Director
  affiliation: KU Leuven
  last name: Claudi L.H. Bockting, Professor
  phone: +3120-8913600
  email: c.l.bockting@amsterdamumc.nl
  last name: Nadia Van Der Spek, PhD
  phone: +31624138237
  email: n.vanderspek@amsterdamumc.nl
  facility: 
  status: Recruiting
  contact: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  investigator full name: Claudi Bockting
  investigator title: Professor
  mesh term: Suicidal Ideation
  sharing ipd: No