<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/NCT03027440</url>
  </required_header>
  <id_info>
    <org_study_id>999917036</org_study_id>
    <secondary_id>17-CH-N036</secondary_id>
    <nct_id>NCT03027440</nct_id>
  </id_info>
  <brief_title>The Developmental Origins of Suicide Mortality</brief_title>
  <official_title>The Developmental Origins of Suicide Mortality</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Suicide rates are rising. In 2013, it was the third leading cause of death in children ages&#xD;
      10-14. It was the second leading cause of death for ages 15-24. Many risk factors for suicide&#xD;
      have been found. But it is hard to predict. Evidence is growing that some factors that may&#xD;
      make people vulnerable to suicide can be identified before birth or in early childhood.&#xD;
      Researchers want to study vulnerability to suicide. They want to look at different kinds of&#xD;
      development. These include prenatal, social, behavioral, cognitive, and neurologic. They will&#xD;
      do this by linking data from the United States Collaborate Perinatal Project (CPP) to the&#xD;
      National Death Index (NDI). The CPP data are from about 50,000 children born to mothers who&#xD;
      enrolled in the 1960s. The CPP observed and examined about 60,000 pregnancies. Then it&#xD;
      followed the babies from when they were born through age 7. The CPP collected data on things&#xD;
      like family and medical history, economic status, and behavior. The NDI has data on the date&#xD;
      and cause of death.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To link data from the CPP to the NDI in order to study certain precursors to suicide.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Offspring born to women who enrolled in the CPP in 1959-1966 and known to be alive at age 7&#xD;
      (Note: at the start of this study around in 2016, the youngest of those still alive would be&#xD;
      50 and the oldest would be 57 years old).&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Data on children from the CPP will be submitted electronically to the NDI. It will be&#xD;
      encrypted and data from the NDI will be deidentified to protect confidentiality. It will then&#xD;
      be merged with existing CPP data. Researchers will analyze the data.&#xD;
&#xD;
      ...&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective:&#xD;
&#xD;
      The overarching objective of this study is to ascertain the vital status and cause-specific&#xD;
      mortality of children born to participants in the Collaborative Perinatal Project (CPP)&#xD;
      between 1959 and 1966 in order to investigate domains of vulnerability to suicide that are&#xD;
      hypothesized to be established in early childhood. This will be accomplished by linking&#xD;
      existing data in the NICHD-CPP cohort to the National Death Index (NCHS National Center for&#xD;
      Health Statistics). This project does not involve direct contact with human subjects&#xD;
      participants.&#xD;
&#xD;
      The rationale for this project is as follows. Suicide rates are rising, from 10.43/100,000 in&#xD;
      2000 to 13.02/100,000 in 2013. In 2013, suicide was the third leading cause of death among&#xD;
      children ages 10-14 years and the second leading cause of death between ages 15 and 24.&#xD;
      Suicide accounts for 800,000 years of potential life lost annually. In addition to an&#xD;
      economic impact exceeding $40 billion per year, it has devastating personal impacts on&#xD;
      survivors as well as the general public. Although numerous risk factors have been identified,&#xD;
      including prior attempts, traumatic or stressful life events, and sociodemographic,&#xD;
      psychiatric, psychological, biological and family, and socioeconomic characteristics,&#xD;
      accurate prediction of suicide remains elusive even in high-risk groups.&#xD;
&#xD;
      To date, epidemiologic studies of suicide have largely focused on proximal risk factors and&#xD;
      developmental stages beyond the initial formation of vulnerability, despite growing evidence&#xD;
      that frames psychiatric disorders as neurodevelopmental disorders. Evidence is also&#xD;
      increasing that adolescent and adult precipitants of suicide have roots in early childhood.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      The study population consists of 52,966 offspring born to women who enrolled in the CPP and&#xD;
      known to be alive at age 7 years; at the time of the NDI search, in 2016, the youngest of&#xD;
      those still alive would be 50 and the oldest would be 57 years old. The CPP involved the&#xD;
      systematic and extensive observation and examination of 58,760 pregnancies, including&#xD;
      collection of blood samples collected at the first and subsequent prenatal visits, and&#xD;
      follow-up assessments of offspring through the first 7 years of life (Niswander and Gordon,&#xD;
      1972). National follow-up rates for surviving offspring (96.7% of study births at age 7&#xD;
      years) were 88% at year 1, 75% at year 4, and 79% at year 7.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      This study consists of secondary analyses in which CPP offspring data will be linked to the&#xD;
      National Death Index to determine vital status and cause(s) of death. NICHD is the steward of&#xD;
      personally identifying information from the CPP. Data on offspring, including date (month,&#xD;
      day, and year), name, father s surname, state of birth, and race/ethnicity will be submitted&#xD;
      to the National Death Index (NDI) for a record search covering the years 1979 to 2016 (all&#xD;
      years included within the NDI). Results of the NDI linkage will be anonymized and then merged&#xD;
      with existing CPP data for statistical analyses. Hypotheses to be tested include the&#xD;
      following:&#xD;
&#xD;
      Examples of hypotheses to be tested include the following:&#xD;
&#xD;
        1. Being born small for gestational age (SGA), low birth weight (LBW), and exposure to&#xD;
           maternal metabolic (e.g., gestational diabetes) and psychiatric conditions will be&#xD;
           associated with an increased risk for suicide mortality.&#xD;
&#xD;
        2. Family socioeconomic disadvantage, residential instability, and family disruption during&#xD;
           the first 7 years of life will be associated with an increased risk of suicide&#xD;
           mortality.&#xD;
&#xD;
        3. Children whose behavioral profiles are characterized by low attention, conduct problems,&#xD;
           and emotional withdrawal will have an elevated risk of suicide.&#xD;
&#xD;
        4. Children with lower scores on tests of intelligence at ages 4 and 7 will have an&#xD;
           increased risk of suicide.&#xD;
&#xD;
        5. Neurological soft signs and neurological hard signs detected in clinical examinations&#xD;
           during early childhood will be associated with later suicide risk.&#xD;
&#xD;
        6. There will be a systematic pattern of differences between 275 suicide cases and 550&#xD;
           matched controls selected from among the remaining CPP offspring, with cases exhibiting&#xD;
           a pattern of biomarker concentrations consistent with a perturbation of the maternal&#xD;
           immune system from what would be expected during a normal pregnancy.&#xD;
&#xD;
      Outcome measures:&#xD;
&#xD;
      Suicide mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 10, 2017</start_date>
  <completion_date type="Anticipated">July 23, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 13, 2024</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Suicide mortality</measure>
    <time_frame>Study completion</time_frame>
    <description>Suicide mortality for each CPP offspring as determined from results of National Death Index search</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">52966</enrollment>
  <condition>Suicide Mortality</condition>
  <arm_group>
    <arm_group_label>CPP Cohort</arm_group_label>
    <description>offspring born to historic CPP cohort participant mothers between 1959 and 1966 who were known to be alive at age 7 (if still alive at the time of NDI search, ages 50 to 57 years old)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects are offspring (n=52,966) born to historic CPP cohort participant mothers&#xD;
        between 1959 and 1966 who were known to be alive at age 7 (96.7% of 54,772 total live&#xD;
        births), and who would be ages 50 to 57 years at the time of the NDI search if still alive.&#xD;
        No new subject accrual is requested. CPP mothers have been previously described. Briefly,&#xD;
        they include 46.2% white women, 46.0% were black, 6.8% were Hispanic and 1% of Asian or&#xD;
        other descent. Approximately 6% of white and 16% of black mothers were under 18 years old&#xD;
        at the time of enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION/EXCLUSION: All subjects are offspring of historic CPP cohort members. No&#xD;
             additional inclusion or exclusion criteria will be applied.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen E Gilman, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute of Child Health and Human Development (NICHD)</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 22, 2023</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress Response</keyword>
  <keyword>Neurodevelopment</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>Cohort Study</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>.N/A--There is no patient recruitment in this study.</ipd_description>
  </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/NCT03027440
org study id: 999917036
secondary id: 17-CH-N036
nct id: NCT03027440
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      Suicide rates are rising. In 2013, it was the third leading cause of death in children ages
      10-14. It was the second leading cause of death for ages 15-24. Many risk factors for suicide
      have been found. But it is hard to predict. Evidence is growing that some factors that may
      make people vulnerable to suicide can be identified before birth or in early childhood.
      Researchers want to study vulnerability to suicide. They want to look at different kinds of
      development. These include prenatal, social, behavioral, cognitive, and neurologic. They will
      do this by linking data from the United States Collaborate Perinatal Project (CPP) to the
      National Death Index (NDI). The CPP data are from about 50,000 children born to mothers who
      enrolled in the 1960s. The CPP observed and examined about 60,000 pregnancies. Then it
      followed the babies from when they were born through age 7. The CPP collected data on things
      like family and medical history, economic status, and behavior. The NDI has data on the date
      and cause of death.

      Objective:

      To link data from the CPP to the NDI in order to study certain precursors to suicide.

      Eligibility:

      Offspring born to women who enrolled in the CPP in 1959-1966 and known to be alive at age 7
      (Note: at the start of this study around in 2016, the youngest of those still alive would be
      50 and the oldest would be 57 years old).

      Design:

      Data on children from the CPP will be submitted electronically to the NDI. It will be
      encrypted and data from the NDI will be deidentified to protect confidentiality. It will then
      be merged with existing CPP data. Researchers will analyze the data.

      ...
Objective:

      The overarching objective of this study is to ascertain the vital status and cause-specific
      mortality of children born to participants in the Collaborative Perinatal Project (CPP)
      between 1959 and 1966 in order to investigate domains of vulnerability to suicide that are
      hypothesized to be established in early childhood. This will be accomplished by linking
      existing data in the NICHD-CPP cohort to the National Death Index (NCHS National Center for
      Health Statistics). This project does not involve direct contact with human subjects
      participants.

      The rationale for this project is as follows. Suicide rates are rising, from 10.43/100,000 in
      2000 to 13.02/100,000 in 2013. In 2013, suicide was the third leading cause of death among
      children ages 10-14 years and the second leading cause of death between ages 15 and 24.
      Suicide accounts for 800,000 years of potential life lost annually. In addition to an
      economic impact exceeding $40 billion per year, it has devastating personal impacts on
      survivors as well as the general public. Although numerous risk factors have been identified,
      including prior attempts, traumatic or stressful life events, and sociodemographic,
      psychiatric, psychological, biological and family, and socioeconomic characteristics,
      accurate prediction of suicide remains elusive even in high-risk groups.

      To date, epidemiologic studies of suicide have largely focused on proximal risk factors and
      developmental stages beyond the initial formation of vulnerability, despite growing evidence
      that frames psychiatric disorders as neurodevelopmental disorders. Evidence is also
      increasing that adolescent and adult precipitants of suicide have roots in early childhood.

      Study population:

      The study population consists of 52,966 offspring born to women who enrolled in the CPP and
      known to be alive at age 7 years; at the time of the NDI search, in 2016, the youngest of
      those still alive would be 50 and the oldest would be 57 years old. The CPP involved the
      systematic and extensive observation and examination of 58,760 pregnancies, including
      collection of blood samples collected at the first and subsequent prenatal visits, and
      follow-up assessments of offspring through the first 7 years of life (Niswander and Gordon,
      1972). National follow-up rates for surviving offspring (96.7% of study births at age 7
      years) were 88% at year 1, 75% at year 4, and 79% at year 7.

      Design:

      This study consists of secondary analyses in which CPP offspring data will be linked to the
      National Death Index to determine vital status and cause(s) of death. NICHD is the steward of
      personally identifying information from the CPP. Data on offspring, including date (month,
      day, and year), name, father s surname, state of birth, and race/ethnicity will be submitted
      to the National Death Index (NDI) for a record search covering the years 1979 to 2016 (all
      years included within the NDI). Results of the NDI linkage will be anonymized and then merged
      with existing CPP data for statistical analyses. Hypotheses to be tested include the
      following:

      Examples of hypotheses to be tested include the following:

        1. Being born small for gestational age (SGA), low birth weight (LBW), and exposure to
           maternal metabolic (e.g., gestational diabetes) and psychiatric conditions will be
           associated with an increased risk for suicide mortality.

        2. Family socioeconomic disadvantage, residential instability, and family disruption during
           the first 7 years of life will be associated with an increased risk of suicide
           mortality.

        3. Children whose behavioral profiles are characterized by low attention, conduct problems,
           and emotional withdrawal will have an elevated risk of suicide.

        4. Children with lower scores on tests of intelligence at ages 4 and 7 will have an
           increased risk of suicide.

        5. Neurological soft signs and neurological hard signs detected in clinical examinations
           during early childhood will be associated with later suicide risk.

        6. There will be a systematic pattern of differences between 275 suicide cases and 550
           matched controls selected from among the remaining CPP offspring, with cases exhibiting
           a pattern of biomarker concentrations consistent with a perturbation of the maternal
           immune system from what would be expected during a normal pregnancy.

      Outcome measures:

      Suicide mortality.
observational model: Cohort
time perspective: Retrospective
measure: Suicide mortality
time frame: Study completion
description: Suicide mortality for each CPP offspring as determined from results of National Death Index search
arm group label: CPP Cohort
description: offspring born to historic CPP cohort participant mothers between 1959 and 1966 who were known to be alive at age 7 (if still alive at the time of NDI search, ages 50 to 57 years old)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Stephen E Gilman, ScD
role: Principal Investigator
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
facility: 
country: United States
responsible party type: Sponsor
mesh term: Suicide
sharing ipd: No
ipd description: .N/A--There is no patient recruitment in this study.