<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/NCT03830476</url>
  </required_header>
  <id_info>
    <org_study_id>Navigator ACT</org_study_id>
    <nct_id>NCT03830476</nct_id>
  </id_info>
  <brief_title>Navigator ACT Group Intervention for Parents of Children With Disabilities</brief_title>
  <acronym>NavigatorACT</acronym>
  <official_title>Navigator ACT-Acceptance and Commitment Therapy-group Treatment for Distressed and Stressed Parents of Children With Disabilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Stockholm</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</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>
      The main purpose of the pragmatic multicenter studies is to investigate the trransdiagnostic,&#xD;
      manualized acceptance and commitment (ACT) therapy group treatment (Navigator ACT) in&#xD;
      treatment of stress and distress in parents of children with disabilities, and to investigate&#xD;
      the concepts of experiential avoidance and psychological flexibility in the context of&#xD;
      parenting. The first phase includes a feasibility study (n=94) of the Navigator ACT for&#xD;
      parents of children (0-17 years) with disabilties who participate in the Navigator ACT group&#xD;
      treatment after being screened for symptoms of stress, depression and anxiety associated with&#xD;
      the challenges of parenting. In the second phase a randomised controlled trial (RCT) is&#xD;
      conducted. In the RCT, we expect to include approximately n=100 parents of children with&#xD;
      disabilties divided into experiment- and control groups. The recruitment takes places in&#xD;
      several regions in Sweden. In addition, we are going to complete a psychometric evaluation of&#xD;
      the main outcome instrument used in these studies, The Parental Acceptance and Action&#xD;
      Questionnaire (PAAQ). In an additional study (expected n= ca 600), we will predict factors&#xD;
      that explain treatment outcome and attrition as well as investigate process variables in a&#xD;
      mediation model,&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Navigator ACT group treatment is a novel, manual-based, transdiagnostic group treatment&#xD;
      developed in Habilitation and Health, the disability services in the region Stockholm. The&#xD;
      treatment consists of 5 sessions (each 3.5 hours), and is developed to address stress and&#xD;
      distress in parents raising a child with disability. The aims of the several studies included&#xD;
      in this project is to examine the feasibility and effectiveness/efficacy of the manual-based&#xD;
      Navigator ACT group treatment in the Swedish habilitation services context. The guestions we&#xD;
      ask are; Is the Navigator ACT a feasible treatment? Is it effective in (a) improving parental&#xD;
      psychological flexibility/experiential acceptance (b) increasing mindfulness (c) reducing&#xD;
      symptoms of depression and anxiety (d) reducing parenting stress (e) reducing parent-reported&#xD;
      difficulties (e.g., behavioral problems) of children with disability.&#xD;
&#xD;
      FAS 1: The feasibility study is conducted in 7 disability service clinics in Stockholm and&#xD;
      Uppsala, Sweden.The feasibility of Navigator ACT in the disability services context is&#xD;
      measured by attendance, that is: parents participating in at least 4 out of 5 sessions are&#xD;
      considered as completers. The parent and treatment provider satisfaction is measured by&#xD;
      session- and course evaluations. Both parents and group leaders treatment credibility and&#xD;
      expectancy is measured as well. Five self-rating questionnaires are used to measure efficacy:&#xD;
      The Mindfulness Awareness Attention Scale (MAAS), Parental Acceptance and Action&#xD;
      Questionnaire (PAAQ) Parental Stress Scale (PSS) Hospital Anxiety and depression scale&#xD;
      (HADS), The Strengths and Difficulties Questionnaire (SDQ). Self-rating questionnaires are&#xD;
      administered to parents at the baseline (0-2 weeks before the treatment start, T1), at the&#xD;
      end of the treatment (0-2 weeks after, T2) and at the follow-up (3-4 months after the end of&#xD;
      the treatment, T3). The data will be analyzed from baseline T1 to T2 (post treatment) as well&#xD;
      as from T1 (baseline) to T3 (follow-up) with separate series of repeated measures ANOVA&#xD;
      between-group.&#xD;
&#xD;
      FAS 2: Psychometric evaluation of the Parental Acceptance and Action Questionnaire (PAAQ).&#xD;
&#xD;
      FAS 2. The pragmatic multicenter RCT will be conducted in four regions of Sweden. Parents&#xD;
      participating in the study have their children (0-17 years) currently enrolled in the&#xD;
      disability services (experiment group n=42, control group n=42, totaling at least 84 parents,&#xD;
      with the power calculation for medium large effect of 90% ES=0.50). To balance for attrition&#xD;
      approximately 100 parents will be included in the study. The participants will be block&#xD;
      randomized in several blocks. The experiment group will be receiving Navigator ACT treatment&#xD;
      directly after the randomizing procedure, the control group approximately six months after.&#xD;
      The parents in the control group fill the efficacy-related self-rating forms at the same&#xD;
      measuring points as the parents in the experiment group as well during their own group&#xD;
      process. The differences between the experiment and control groups will be analyzed by&#xD;
      mixed-model linear regression.&#xD;
&#xD;
      FAS4: The aim of this study is reveal which parents get the most benefit of the Navigator ACT&#xD;
      treatment, and what factors predict treatment competition vs. attrition. An additional aim is&#xD;
      to investigate what treatment specific ACT processes mediate the treatment outcomes.&#xD;
&#xD;
      The Regional Ethics Committee of Stockholm (2016/526-21-1,2016/115-31/4, 2017/573-31/5 ) has&#xD;
      approved the studIes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2016</start_date>
  <completion_date type="Actual">October 31, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2021</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>Feasibility study and Randomised Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>Masking at baseline of both participant and care-provider.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>1. Change (increase) in parental psychological flexibility and experiential acceptance</measure>
    <time_frame>[Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]</time_frame>
    <description>Parental Acceptance and Action Questionnaire (PAAQ), a scale that targets psychological flexibility and experiential acceptance in the parenting context, i.e. measures to which extent parents' accept inner experiences related to parenting and the readiness to take appropriate/needed action in parenting (commitment to values-based actions). Originally 19-item scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>2. Change (increase) in mindfulness skills</measure>
    <time_frame>[Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]</time_frame>
    <description>The Mindfulness Awareness Attention Scale (MAAS), a 15-item scale (scored 1-6) assessing dispositional mindfulness in regards to cognitive, emotional, physical, interpersonal and general domains.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3. Change (decrease) in depression and anxiety</measure>
    <time_frame>[Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS). Has 14 items scored 0 (&quot;Often&quot;) - 3 (&quot;Seldom&quot;), subsequently summarized for an overall score; high scores indicate higher levels of depression or anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>4. Change (decrease) in parental stress.</measure>
    <time_frame>[Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]</time_frame>
    <description>The Parental Stress Scale (PSS) is a18-item tool for measurement of parenting stress, scored 1-5 on a 5-point Likert scale. The initial factor has suggested four-factor structure for the PSS consisting of parental 1) rewards, 2) stressors, 3) lack of control and 4) satisfaction in parenting. High scores indicate higher levels of stress in parenting context.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5. Change (decrease) in child's difficulties and the impact of these difficulties on the child's family.</measure>
    <time_frame>[Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]</time_frame>
    <description>The Strengths and Difficulties Questionnaire (P4-17 SDQ), a caregiver administered, 25-item extended version of SDQ used for behavior screening of children and adolescents in ages 4-17 years. The SDQ P4-17 covers common areas of emotional and behavioral difficulties and strengths as well as includes a caregiver reported impact- and burden assessment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Treatment Credibility Scale (TCS)</measure>
    <time_frame>Measured at baseline,and immediately after the intervention.</time_frame>
    <description>As a measure of feasibility, TCS is used to measure the expectation of improvement and treatment credibility. The TCS is a visual analogue scale rated from &quot;Low credibility&quot;/ &quot;Not at all&quot; (0) to &quot;High credibility&quot;/&quot;Very much&quot; (10) and the score calculated is a mean of all items. The TCS was administered after providing thorough information and presentation of the treatment content at baseline and after completion of the treatment. The item wording after adjustment to the current study were: (1) How logical does Navigator ACT treatment seem to you? (2) How confident are you that this treatment will reduce your distress? (3) Would you recommend Navigator ACT to a friend experiencing the same type of distress? (4) How successful do you feel this type of intervention is in improving your psychological health? 5) At this very moment, to what degree the intervention has improved your psychological health?</description>
  </other_outcome>
  <other_outcome>
    <measure>Session Evaluation Form (SEF)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Measures treatment satisfaction regarding each treatment session</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Evaluation Form (PEF)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Measures overall treatment satisfaction</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">129</enrollment>
  <condition>Parenting</condition>
  <condition>Stress</condition>
  <condition>Disability, Developmental</condition>
  <condition>Behavior, Child</condition>
  <condition>Acceptance and Action Processes</condition>
  <condition>Parent-Child Relations</condition>
  <condition>Experiential Avoidance</condition>
  <condition>Depression, Anxiety</condition>
  <arm_group>
    <arm_group_label>Acceptance- and Commitment therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experiment group that receives the treatment direct after the baseline measurement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Comparison group that receives treatment as usual and the Navigator ACT intervention appr 6 months later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Acceptance- and Commitment therapy group for parents to children with disabilities</intervention_name>
    <description>ACT groups adjusted for parents of children with (any kind of) disabilities.</description>
    <arm_group_label>Acceptance- and Commitment therapy group</arm_group_label>
    <other_name>Navigator ACT group treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as usual.</intervention_name>
    <description>Treatment as usual within outpatient disability services.</description>
    <arm_group_label>Treatment as usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a parent to a child 0-17 years with disability&#xD;
&#xD;
          -  mild to severe symptoms of parental stress, depression or anxiety&#xD;
&#xD;
          -  a possibility to participate in all group sessions&#xD;
&#xD;
          -  an ability to function in a group&#xD;
&#xD;
          -  a knowledge of the Swedish language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  deep depression with suicidality&#xD;
&#xD;
          -  psychosis or manic episodes&#xD;
&#xD;
          -  severe post-traumatic stress disorder (PTSD)&#xD;
&#xD;
          -  homelessness or other extreme life situation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Parent report their own and their child's gender during the screening interview.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tiina Maria Holmberg Bergman</name>
      <address>
        <city>Knivsta</city>
        <zip>74131</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>https://link.springer.com/content/pdf/10.1007/s10803-022-05490-6.pdf</url>
    <description>Acceptance and Commitment Therapy Group Intervention for Parents of Children with Disabilities (Navigator ACT): An Open Feasibility Trial</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Tatja Hirvikoski</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Acceptance- and Commitment Therapy, ACT, parenting stress, parenting a child with disability, depression, anxiety, disabilities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Developmental Disabilities</mesh_term>
  </condition_browse>
  <!-- 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/NCT03830476
org study id: Navigator ACT
nct id: NCT03830476
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of the pragmatic multicenter studies is to investigate the trransdiagnostic,
      manualized acceptance and commitment (ACT) therapy group treatment (Navigator ACT) in
      treatment of stress and distress in parents of children with disabilities, and to investigate
      the concepts of experiential avoidance and psychological flexibility in the context of
      parenting. The first phase includes a feasibility study (n=94) of the Navigator ACT for
      parents of children (0-17 years) with disabilties who participate in the Navigator ACT group
      treatment after being screened for symptoms of stress, depression and anxiety associated with
      the challenges of parenting. In the second phase a randomised controlled trial (RCT) is
      conducted. In the RCT, we expect to include approximately n=100 parents of children with
      disabilties divided into experiment- and control groups. The recruitment takes places in
      several regions in Sweden. In addition, we are going to complete a psychometric evaluation of
      the main outcome instrument used in these studies, The Parental Acceptance and Action
      Questionnaire (PAAQ). In an additional study (expected n= ca 600), we will predict factors
      that explain treatment outcome and attrition as well as investigate process variables in a
      mediation model,
Navigator ACT group treatment is a novel, manual-based, transdiagnostic group treatment
      developed in Habilitation and Health, the disability services in the region Stockholm. The
      treatment consists of 5 sessions (each 3.5 hours), and is developed to address stress and
      distress in parents raising a child with disability. The aims of the several studies included
      in this project is to examine the feasibility and effectiveness/efficacy of the manual-based
      Navigator ACT group treatment in the Swedish habilitation services context. The guestions we
      ask are; Is the Navigator ACT a feasible treatment? Is it effective in (a) improving parental
      psychological flexibility/experiential acceptance (b) increasing mindfulness (c) reducing
      symptoms of depression and anxiety (d) reducing parenting stress (e) reducing parent-reported
      difficulties (e.g., behavioral problems) of children with disability.

      FAS 1: The feasibility study is conducted in 7 disability service clinics in Stockholm and
      Uppsala, Sweden.The feasibility of Navigator ACT in the disability services context is
      measured by attendance, that is: parents participating in at least 4 out of 5 sessions are
      considered as completers. The parent and treatment provider satisfaction is measured by
      session- and course evaluations. Both parents and group leaders treatment credibility and
      expectancy is measured as well. Five self-rating questionnaires are used to measure efficacy:
      The Mindfulness Awareness Attention Scale (MAAS), Parental Acceptance and Action
      Questionnaire (PAAQ) Parental Stress Scale (PSS) Hospital Anxiety and depression scale
      (HADS), The Strengths and Difficulties Questionnaire (SDQ). Self-rating questionnaires are
      administered to parents at the baseline (0-2 weeks before the treatment start, T1), at the
      end of the treatment (0-2 weeks after, T2) and at the follow-up (3-4 months after the end of
      the treatment, T3). The data will be analyzed from baseline T1 to T2 (post treatment) as well
      as from T1 (baseline) to T3 (follow-up) with separate series of repeated measures ANOVA
      between-group.

      FAS 2: Psychometric evaluation of the Parental Acceptance and Action Questionnaire (PAAQ).

      FAS 2. The pragmatic multicenter RCT will be conducted in four regions of Sweden. Parents
      participating in the study have their children (0-17 years) currently enrolled in the
      disability services (experiment group n=42, control group n=42, totaling at least 84 parents,
      with the power calculation for medium large effect of 90% ES=0.50). To balance for attrition
      approximately 100 parents will be included in the study. The participants will be block
      randomized in several blocks. The experiment group will be receiving Navigator ACT treatment
      directly after the randomizing procedure, the control group approximately six months after.
      The parents in the control group fill the efficacy-related self-rating forms at the same
      measuring points as the parents in the experiment group as well during their own group
      process. The differences between the experiment and control groups will be analyzed by
      mixed-model linear regression.

      FAS4: The aim of this study is reveal which parents get the most benefit of the Navigator ACT
      treatment, and what factors predict treatment competition vs. attrition. An additional aim is
      to investigate what treatment specific ACT processes mediate the treatment outcomes.

      The Regional Ethics Committee of Stockholm (2016/526-21-1,2016/115-31/4, 2017/573-31/5 ) has
      approved the studIes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Feasibility study and Randomised Controlled Trial
primary purpose: Treatment
masking: Single (Care Provider)
masking description: Masking at baseline of both participant and care-provider.
measure: 1. Change (increase) in parental psychological flexibility and experiential acceptance
time frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
description: Parental Acceptance and Action Questionnaire (PAAQ), a scale that targets psychological flexibility and experiential acceptance in the parenting context, i.e. measures to which extent parents' accept inner experiences related to parenting and the readiness to take appropriate/needed action in parenting (commitment to values-based actions). Originally 19-item scale.
measure: 2. Change (increase) in mindfulness skills
time frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
description: The Mindfulness Awareness Attention Scale (MAAS), a 15-item scale (scored 1-6) assessing dispositional mindfulness in regards to cognitive, emotional, physical, interpersonal and general domains.
measure: 3. Change (decrease) in depression and anxiety
time frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
description: Hospital Anxiety and Depression Scale (HADS). Has 14 items scored 0 ("Often") - 3 ("Seldom"), subsequently summarized for an overall score; high scores indicate higher levels of depression or anxiety.
measure: 4. Change (decrease) in parental stress.
time frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
description: The Parental Stress Scale (PSS) is a18-item tool for measurement of parenting stress, scored 1-5 on a 5-point Likert scale. The initial factor has suggested four-factor structure for the PSS consisting of parental 1) rewards, 2) stressors, 3) lack of control and 4) satisfaction in parenting. High scores indicate higher levels of stress in parenting context.
measure: 5. Change (decrease) in child's difficulties and the impact of these difficulties on the child's family.
time frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
description: The Strengths and Difficulties Questionnaire (P4-17 SDQ), a caregiver administered, 25-item extended version of SDQ used for behavior screening of children and adolescents in ages 4-17 years. The SDQ P4-17 covers common areas of emotional and behavioral difficulties and strengths as well as includes a caregiver reported impact- and burden assessment.
measure: Treatment Credibility Scale (TCS)
time frame: Measured at baseline,and immediately after the intervention.
description: As a measure of feasibility, TCS is used to measure the expectation of improvement and treatment credibility. The TCS is a visual analogue scale rated from "Low credibility"/ "Not at all" (0) to "High credibility"/"Very much" (10) and the score calculated is a mean of all items. The TCS was administered after providing thorough information and presentation of the treatment content at baseline and after completion of the treatment. The item wording after adjustment to the current study were: (1) How logical does Navigator ACT treatment seem to you? (2) How confident are you that this treatment will reduce your distress? (3) Would you recommend Navigator ACT to a friend experiencing the same type of distress? (4) How successful do you feel this type of intervention is in improving your psychological health? 5) At this very moment, to what degree the intervention has improved your psychological health?
measure: Session Evaluation Form (SEF)
time frame: Up to 3 months
description: Measures treatment satisfaction regarding each treatment session
measure: Patient Evaluation Form (PEF)
time frame: Up to 3 months
description: Measures overall treatment satisfaction
arm group label: Acceptance- and Commitment therapy group
arm group type: Experimental
description: Experiment group that receives the treatment direct after the baseline measurement.
arm group label: Treatment as usual
arm group type: Active Comparator
description: Comparison group that receives treatment as usual and the Navigator ACT intervention appr 6 months later.
intervention type: Behavioral
intervention name: Acceptance- and Commitment therapy group for parents to children with disabilities
description: ACT groups adjusted for parents of children with (any kind of) disabilities.
arm group label: Acceptance- and Commitment therapy group
other name: Navigator ACT group treatment
intervention type: Behavioral
intervention name: Treatment as usual.
description: Treatment as usual within outpatient disability services.
arm group label: Treatment as usual
criteria: 
gender: All
gender based: Yes
gender description: Parent report their own and their child's gender during the screening interview.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
url: https://link.springer.com/content/pdf/10.1007/s10803-022-05490-6.pdf
description: Acceptance and Commitment Therapy Group Intervention for Parents of Children with Disabilities (Navigator ACT): An Open Feasibility Trial
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Tatja Hirvikoski
investigator title: Associate Professor
mesh term: Depression
mesh term: Developmental Disabilities