<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/NCT03775135</url>
  </required_header>
  <id_info>
    <org_study_id>S0000</org_study_id>
    <nct_id>NCT03775135</nct_id>
  </id_info>
  <brief_title>Identity Development in Youth With Neuromuscular Diseases</brief_title>
  <official_title>Identity Development in Youth With Neuromuscular Diseases: A Clinically Relevant But Forgotten Issue in the Transition to Adulthood</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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>
      Up to 20% of the adolescents worldwide are diagnosed with a chronic illness. Although it's&#xD;
      known that these young people suffer from a wide range of physical discomfort, in real life&#xD;
      they have to cope with much more challenges whether or not caused by their physical&#xD;
      situation. Psychiatric disorders (e.g. ASS, ADHD or depression) are more often diagnosed in&#xD;
      this population compared to their healthy peers. The causal mechanisms for this higher risk,&#xD;
      however, are yet unknown.&#xD;
&#xD;
      This project examines three underlying intrapersonal processes possibly having an impact on&#xD;
      the evolution of these secondary symptoms. Previous research confirmed the significant impact&#xD;
      of having a chronic illness on the development of identity and the association with a higher&#xD;
      prevalence of depressive symptoms. Identity formation is a crucial developmental task to&#xD;
      transfer from a child to an independent, responsible adult. We believe this developmental&#xD;
      task is more at risk for youngsters and young adults suffering from a physical disability,&#xD;
      caused by a neuromuscular disease. In this longitudinal research project, we investigate the&#xD;
      development of identity in youth with a neuromuscular disease, compared to healthy peers and&#xD;
      compared to a group of peers with a non-visible chronical illness. We also evaluate the&#xD;
      impact of the degree of physical functioning on those mechanisms. Second, we examine if&#xD;
      parental behavior and parental functioning is linked with the formation of identity in a&#xD;
      neuromuscular populations. Finally, the impact of identity formation on psychosocial outcomes&#xD;
      (e.g. feelings of depression and anxiety, quality of life, …) is measured.&#xD;
&#xD;
      By addressing these research questions, this project will add substantially to our knowledge&#xD;
      on identity in chronic illness and can inform future prevention and intervention efforts&#xD;
      targeting illness adaptation and parental functioning in order to prevent negative&#xD;
      psychosocial outcomes and to optimize quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A large-scale, multi-informant, two-wave longitudinal study is proposed to investigate our&#xD;
      three different research objectives, using complementary methods and multiple sources for&#xD;
      data collection. Such a longitudinal design allows for examining developmental trajectories&#xD;
      of our core identity variables, as well as examining how these identity variables are related&#xD;
      to other variables over time. As such, we will investigate integrative pathways linking&#xD;
      contextual factors to identity development and broader psychosocial functioning, enabling us&#xD;
      to forward important information for clinical practice. Before the start of the study, an&#xD;
      approval from the ethical commission will be obtained. All data will be coded anonymously and&#xD;
      stored in a confidential database. We aim to recruit 200 adolescents and emerging adults with&#xD;
      a neuromuscular disease, like DMD patients (Duchenne Muscular Dystrophy), SMA patients&#xD;
      (Spinal Muscular Atrophy), CMT patients (Charcot Marie Tooth) and MD1 patients (Myotonic&#xD;
      Dystrophy, type 1). Patients will be included in this study if they meet the following&#xD;
      criteria: confirmed diagnoses of a neuromuscular disorder; aged 12-25 years at baseline; last&#xD;
      neuromuscular consult at our NMRC is 5 or less years ago; able to read and write Dutch; and&#xD;
      valid contact details available in the clinical database or the hospital information system.&#xD;
      Given the complex data-analyses, it is difficult to perform an exact power analysis, but the&#xD;
      anticipated sample size is suited for the planned analyses (Kline, 2005). To make a useful&#xD;
      comparison, we will include a control sample of age- and gender-matched healthy adolescents&#xD;
      and a group of age- and gender-matched adolescents diagnosed with type 1 diabetes. Those&#xD;
      control participants will be recruited in secondary schools and universities, while we are&#xD;
      able to use the data of an ongoing research project in patients with diabetes. To achieve&#xD;
      these aims, this project, as noted, will be in cooperation with the research team from the&#xD;
      Faculty of Psychology and Educational Sciences at KU Leuven.&#xD;
&#xD;
      To investigate our objectives, data will be systematically collected during two years on two&#xD;
      different occasions (T1 and T2), with one year between subsequent time-points. All&#xD;
      neuromuscular patients are supposed to consult their multidisciplinary team every 6 months in&#xD;
      the context of a general control and this gives us the opportunity to ask both adolescents&#xD;
      and parents to complete questionnaires once a year. Depending on the date of the appointment,&#xD;
      patients will start in this survey on different moments, but we will use the same time&#xD;
      interval between time-points for every single patient. For inclusion, adolescents and parents&#xD;
      will be asked to sign informed consents, where after demographic and clinical data can be&#xD;
      obtained anonymously from the patients' medical records. Additional demographic and&#xD;
      socio-economic information will be gathered using a demographic questionnaire at T1. Other&#xD;
      data will be collected using instruments with well-established psychometric characteristics&#xD;
      that mostly include self-reports on all two time-points (T1 and T2). Parents will also be&#xD;
      asked to report on youth functioning as well. Figure 2 shows an overview of our research&#xD;
      design and estimated timeline.&#xD;
&#xD;
      In order to investigate objective 1, adolescents will be asked to complete following&#xD;
      questionnaires on the two different time-points: Dimensions of Identity Development Scale (25&#xD;
      items), Illness Identity Resolution Scale (27 items) and Brief Illness Perception&#xD;
      Questionnaire (8 items). In addition, to examine reciprocal associations between identity&#xD;
      development and the variables forwarded under objectives 2 en 3, adolescents will be asked to&#xD;
      complete self-report questionnaires on psychosocial functioning and perceived support, using&#xD;
      the Center for Epidemiologic Studies Depression Scale (CESD) (20 items) to screen for&#xD;
      depressive symptoms, the Screen for Child Anxiety Related Emotional Disorders (SCARED-NL),&#xD;
      the PedsQLTM Neuromuscular Module to measure quality of life and the Inventory of Peer and&#xD;
      Parent Attachment: subscales Trust, Communication and Alienation (12 items). At the same&#xD;
      time-points parents will be asked to complete the Illness Intrusive Scale (13 items), a scale&#xD;
      about different factors of their parenting: responsiveness (7 items), psychological control&#xD;
      (8 items), behavioral control (7 items) and overprotection/anxious parenting (8 items)&#xD;
      (Parenting Questionnaire) and about the physical dependence of their child (Activ-Lim). To&#xD;
      report about the psychosocial functioning of their child, parents will be asked to fulfill&#xD;
      the Screen for Child Anxiety Related Emotional Disorders (SCARED-NL) and the PedsQLTM&#xD;
      Neuromuscular Module to measure perceived quality of life in the youngster. For evaluating&#xD;
      their own psychosocial functioning, they will be asked to complete the Center for&#xD;
      Epidemiologic Studies Depression Scale (20 items) and a LAS-scale to evaluate their own&#xD;
      quality of life. Necessary measures will be taken to minimize dropout: all participants&#xD;
      receive a reward and Dillman's approach will be used to minimize non-response. Occasional&#xD;
      missing data will be dealt with using appropriate methods (Enders, 2010). State-of-the-art&#xD;
      longitudinal techniques will be used. Cross-lagged analysis will be used to examine&#xD;
      directionality of effect, with appropriate controls for all within-time associations and&#xD;
      stability coefficients. Hence, we can investigate, for instance, whether parents actually&#xD;
      predict illness identity resolutions over time or whether reciprocal effects emerge with, for&#xD;
      instance, illness acceptance also leading to more support. Further, mediation will be tested&#xD;
      from a longitudinal perspective, allowing us to examine, for instance, whether illness&#xD;
      identity resolutions mediate the associations between parental support and outcomes. To chart&#xD;
      developmental trajectories over time, latent growth curve modeling estimates both linear and&#xD;
      non-linear growth and uses information collected at all different time points to derive&#xD;
      parameters of change (i.e., intercept and slope). Finally, latent class growth analysis will&#xD;
      be used to identify distinct developmental trajectory classes in terms of personal and&#xD;
      illness identity resolutions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Changed plans&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Manifestation of identity in 120 patients with neuromuscular diseases</measure>
    <time_frame>up to year 1</time_frame>
    <description>Identity development will be measured with specific questionnaires</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychosocial functioning in 120 patients with neuromuscular diseases</measure>
    <time_frame>up to year 1</time_frame>
    <description>Psychosocial functioning will be measures with specific questionnaires</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Neuromuscular Diseases</condition>
  <arm_group>
    <arm_group_label>Children with neuromuscular diseases</arm_group_label>
    <description>Questionnaires will be administered by children with neuromuscular disease between 12 and 25 years and their parents</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Different questionnaires about identity development and psychosocial functioning will be administered</description>
    <arm_group_label>Children with neuromuscular diseases</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with neuromuscular diseases between 12 and 25 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  confirmed diagnoses of a neuromuscular disorder;&#xD;
&#xD;
          -  aged 12-25 years at baseline;&#xD;
&#xD;
          -  last neuromuscular consult at our NMRC is 5 or less years ago;&#xD;
&#xD;
          -  able to read and write Dutch;&#xD;
&#xD;
          -  valid contact details available in the clinical database or the hospital information&#xD;
             system.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        -Patients that do not fulfill the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathalie Goemans, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Identity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuromuscular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03775135
org study id: S0000
nct id: NCT03775135
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Up to 20% of the adolescents worldwide are diagnosed with a chronic illness. Although it's
      known that these young people suffer from a wide range of physical discomfort, in real life
      they have to cope with much more challenges whether or not caused by their physical
      situation. Psychiatric disorders (e.g. ASS, ADHD or depression) are more often diagnosed in
      this population compared to their healthy peers. The causal mechanisms for this higher risk,
      however, are yet unknown.

      This project examines three underlying intrapersonal processes possibly having an impact on
      the evolution of these secondary symptoms. Previous research confirmed the significant impact
      of having a chronic illness on the development of identity and the association with a higher
      prevalence of depressive symptoms. Identity formation is a crucial developmental task to
      transfer from a child to an independent, responsible adult. We believe this developmental
      task is more at risk for youngsters and young adults suffering from a physical disability,
      caused by a neuromuscular disease. In this longitudinal research project, we investigate the
      development of identity in youth with a neuromuscular disease, compared to healthy peers and
      compared to a group of peers with a non-visible chronical illness. We also evaluate the
      impact of the degree of physical functioning on those mechanisms. Second, we examine if
      parental behavior and parental functioning is linked with the formation of identity in a
      neuromuscular populations. Finally, the impact of identity formation on psychosocial outcomes
      (e.g. feelings of depression and anxiety, quality of life, …) is measured.

      By addressing these research questions, this project will add substantially to our knowledge
      on identity in chronic illness and can inform future prevention and intervention efforts
      targeting illness adaptation and parental functioning in order to prevent negative
      psychosocial outcomes and to optimize quality of life.
A large-scale, multi-informant, two-wave longitudinal study is proposed to investigate our
      three different research objectives, using complementary methods and multiple sources for
      data collection. Such a longitudinal design allows for examining developmental trajectories
      of our core identity variables, as well as examining how these identity variables are related
      to other variables over time. As such, we will investigate integrative pathways linking
      contextual factors to identity development and broader psychosocial functioning, enabling us
      to forward important information for clinical practice. Before the start of the study, an
      approval from the ethical commission will be obtained. All data will be coded anonymously and
      stored in a confidential database. We aim to recruit 200 adolescents and emerging adults with
      a neuromuscular disease, like DMD patients (Duchenne Muscular Dystrophy), SMA patients
      (Spinal Muscular Atrophy), CMT patients (Charcot Marie Tooth) and MD1 patients (Myotonic
      Dystrophy, type 1). Patients will be included in this study if they meet the following
      criteria: confirmed diagnoses of a neuromuscular disorder; aged 12-25 years at baseline; last
      neuromuscular consult at our NMRC is 5 or less years ago; able to read and write Dutch; and
      valid contact details available in the clinical database or the hospital information system.
      Given the complex data-analyses, it is difficult to perform an exact power analysis, but the
      anticipated sample size is suited for the planned analyses (Kline, 2005). To make a useful
      comparison, we will include a control sample of age- and gender-matched healthy adolescents
      and a group of age- and gender-matched adolescents diagnosed with type 1 diabetes. Those
      control participants will be recruited in secondary schools and universities, while we are
      able to use the data of an ongoing research project in patients with diabetes. To achieve
      these aims, this project, as noted, will be in cooperation with the research team from the
      Faculty of Psychology and Educational Sciences at KU Leuven.

      To investigate our objectives, data will be systematically collected during two years on two
      different occasions (T1 and T2), with one year between subsequent time-points. All
      neuromuscular patients are supposed to consult their multidisciplinary team every 6 months in
      the context of a general control and this gives us the opportunity to ask both adolescents
      and parents to complete questionnaires once a year. Depending on the date of the appointment,
      patients will start in this survey on different moments, but we will use the same time
      interval between time-points for every single patient. For inclusion, adolescents and parents
      will be asked to sign informed consents, where after demographic and clinical data can be
      obtained anonymously from the patients' medical records. Additional demographic and
      socio-economic information will be gathered using a demographic questionnaire at T1. Other
      data will be collected using instruments with well-established psychometric characteristics
      that mostly include self-reports on all two time-points (T1 and T2). Parents will also be
      asked to report on youth functioning as well. Figure 2 shows an overview of our research
      design and estimated timeline.

      In order to investigate objective 1, adolescents will be asked to complete following
      questionnaires on the two different time-points: Dimensions of Identity Development Scale (25
      items), Illness Identity Resolution Scale (27 items) and Brief Illness Perception
      Questionnaire (8 items). In addition, to examine reciprocal associations between identity
      development and the variables forwarded under objectives 2 en 3, adolescents will be asked to
      complete self-report questionnaires on psychosocial functioning and perceived support, using
      the Center for Epidemiologic Studies Depression Scale (CESD) (20 items) to screen for
      depressive symptoms, the Screen for Child Anxiety Related Emotional Disorders (SCARED-NL),
      the PedsQLTM Neuromuscular Module to measure quality of life and the Inventory of Peer and
      Parent Attachment: subscales Trust, Communication and Alienation (12 items). At the same
      time-points parents will be asked to complete the Illness Intrusive Scale (13 items), a scale
      about different factors of their parenting: responsiveness (7 items), psychological control
      (8 items), behavioral control (7 items) and overprotection/anxious parenting (8 items)
      (Parenting Questionnaire) and about the physical dependence of their child (Activ-Lim). To
      report about the psychosocial functioning of their child, parents will be asked to fulfill
      the Screen for Child Anxiety Related Emotional Disorders (SCARED-NL) and the PedsQLTM
      Neuromuscular Module to measure perceived quality of life in the youngster. For evaluating
      their own psychosocial functioning, they will be asked to complete the Center for
      Epidemiologic Studies Depression Scale (20 items) and a LAS-scale to evaluate their own
      quality of life. Necessary measures will be taken to minimize dropout: all participants
      receive a reward and Dillman's approach will be used to minimize non-response. Occasional
      missing data will be dealt with using appropriate methods (Enders, 2010). State-of-the-art
      longitudinal techniques will be used. Cross-lagged analysis will be used to examine
      directionality of effect, with appropriate controls for all within-time associations and
      stability coefficients. Hence, we can investigate, for instance, whether parents actually
      predict illness identity resolutions over time or whether reciprocal effects emerge with, for
      instance, illness acceptance also leading to more support. Further, mediation will be tested
      from a longitudinal perspective, allowing us to examine, for instance, whether illness
      identity resolutions mediate the associations between parental support and outcomes. To chart
      developmental trajectories over time, latent growth curve modeling estimates both linear and
      non-linear growth and uses information collected at all different time points to derive
      parameters of change (i.e., intercept and slope). Finally, latent class growth analysis will
      be used to identify distinct developmental trajectory classes in terms of personal and
      illness identity resolutions.
observational model: Cohort
time perspective: Prospective
measure: Manifestation of identity in 120 patients with neuromuscular diseases
time frame: up to year 1
description: Identity development will be measured with specific questionnaires
measure: Psychosocial functioning in 120 patients with neuromuscular diseases
time frame: up to year 1
description: Psychosocial functioning will be measures with specific questionnaires
arm group label: Children with neuromuscular diseases
description: Questionnaires will be administered by children with neuromuscular disease between 12 and 25 years and their parents
intervention type: Other
intervention name: Questionnaires
description: Different questionnaires about identity development and psychosocial functioning will be administered
arm group label: Children with neuromuscular diseases
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nathalie Goemans, MD, PhD
role: Principal Investigator
affiliation: UZ Leuven
responsible party type: Sponsor
mesh term: Neuromuscular Diseases
sharing ipd: No