<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/NCT03010306</url>
  </required_header>
  <id_info>
    <org_study_id>2013P002554</org_study_id>
    <nct_id>NCT03010306</nct_id>
  </id_info>
  <brief_title>CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru</brief_title>
  <official_title>Pilot Community-based Development Intervention (CASITA) for Children With Neurodevelopmental Risk and Delay in Carabayllo, Lima, Peru</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Grand Challenges Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Partners in Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Building on an intervention for early child development from the SPARK Center in Boston,&#xD;
      Socios En Salud (SES) pilot tested &quot;CASITA&quot; a community-based package to screen and treat&#xD;
      young children (ages 1-3 years of age) diagnosed with neurodevelopment risk and delay in&#xD;
      Carabayllo, Lima, Peru. Ministry of Health CHWs identified children with developmental delays&#xD;
      within the clinics and community and delivered a structured early intervention that included&#xD;
      parent coaching and social support. In order to test the hypothesis that CASITA improves&#xD;
      early child development, caregiver, and home environment, dyads received either nutrition&#xD;
      supplements alone, nutrition + &quot;CASITA&quot; early child development sessions individually, or&#xD;
      CASITA in a group of 10 dyads.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in risk of delay, as measured by the EASQ</measure>
    <time_frame>baseline, 3 months</time_frame>
    <description>The Ages and Stages Questionnaire (ASQ) is an internationally-validated instrument that can be used to assess change in developmental risk over time. Fernald et al incorporated additional observation-based assessments and the following modifications: 1) addition of child observation exercises to allow for validity check of parent responses (original ASQ questions), and 2) the incorporation of ASQ questions from the next highest age range. The Extended Ages and Stages Questionnaire (EASQ) was utilized as an assessment tool to allow us to better quantify degree of risk at baseline (based on quintiles of scores). By incorporating ASQ questions from the next two highest age ranges, scores will be continuous across the study period of three. The EASQ has been applied to children in four countries, including 2,845 children in Peru.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in global HOME score</measure>
    <time_frame>baseline, 3 months</time_frame>
    <description>The Infant Toddler Home Observation Measurement of the Environment (HOME) evaluates parenting and home influences on child development.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HOME subscore of parent responsivity</measure>
    <time_frame>baseline, 3 months</time_frame>
    <description>This HOME subscore is defined in the manual as &quot;the extent to which the parent responds to the child's behavior including reinforcement for desired behavior and communication through words and actions&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HOME subscore of parent involvement</measure>
    <time_frame>baseline, 3 months</time_frame>
    <description>This HOME subscore is defined as &quot;parental acceptance of the child's behavior that is less than optimal and examines avoidance of undue restriction and punishment&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Child Developmental Delay</condition>
  <condition>Child Development</condition>
  <condition>Community Health Workers</condition>
  <condition>Low Income Population</condition>
  <arm_group>
    <arm_group_label>Nutrition only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Monthly food baskets were provided to the nutrition only group. Food baskets included basic foods to sustain a family of three over one month's time, such as rice and evaporated milk. Food baskets were valued at approximately $28 US Dollars per basket.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutrition + CASITA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The CASITA intervention was given by a community health worker (CHW) and involves individual and group modalities. HOME-CASITA took place at the dyad's place of residence, and the GROUP-CASITA at a local community center. All CASITA participants received 12 weekly sessions over 3 months. Interventions retain core elements of the SPARK approach: coaching parents on child development stimulation and providing social support and encouragement. Each session is as follows: 1) Child observation &amp; knowledge sharing about child development; 2) Practice of reciprocal attention focusing and social interaction activities; 3) Parent encouragement on behavior and developmental interactions; and 4) Parent social support through referral assistance, reassurance, and validation of parent's concerns.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CASITA</intervention_name>
    <arm_group_label>Nutrition + CASITA</arm_group_label>
    <other_name>Child development coaching and social support in Lima Peru</other_name>
    <other_name>Community-based intervention for children at risk of Neurodevelopment delay</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 6 - 24 months of age;&#xD;
&#xD;
          2. Known primary caregiver (parent or legal guardian) living with child;&#xD;
&#xD;
          3. Living within the catchment area of the 6 Health Centers that comprise the study zone.&#xD;
&#xD;
          4. Screen positive for neurodevelopment delay (&quot;at risk&quot; or &quot;delayed&quot; in neurodevelopment&#xD;
             based on Evaluation del Desarrollo Psicomotor (EEDP) assessment).&#xD;
&#xD;
          5. Be at risk by scoring &lt;45 on the Progress Out of Poverty Index.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A known medical condition that would make the child unresponsive to early&#xD;
             intervention;&#xD;
&#xD;
          2. Family anticipates moving within the next three months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leonid Lecca, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Socios En Salud, Peru</affiliation>
  </overall_official>
  <link>
    <url>http://www.grandchallenges.ca/grantee-stars/0769-05/</url>
    <description>CASITA scale-up: Grand Challenges Canada</description>
  </link>
  <link>
    <url>http://www.savingbrainsinnovation.net/projects/0769-05/</url>
    <description>CASITA scale-up: Saving Brains Innovation</description>
  </link>
  <link>
    <url>https://issuu.com/sociosensalud/docs/early_childhood_development_newslet</url>
    <description>Early Child Development Working Group (Harvard Medical School): Field Feature CASITA</description>
  </link>
  <reference>
    <citation>Grantham-McGregor S, Cheung YB, Cueto S, Glewwe P, Richter L, Strupp B; International Child Development Steering Group. Developmental potential in the first 5 years for children in developing countries. Lancet. 2007 Jan 6;369(9555):60-70. doi: 10.1016/S0140-6736(07)60032-4.</citation>
    <PMID>17208643</PMID>
  </reference>
  <reference>
    <citation>Nahar B, Hamadani JD, Ahmed T, Tofail F, Rahman A, Huda SN, Grantham-McGregor SM. Effects of psychosocial stimulation on growth and development of severely malnourished children in a nutrition unit in Bangladesh. Eur J Clin Nutr. 2009 Jun;63(6):725-31. doi: 10.1038/ejcn.2008.44. Epub 2008 Sep 3.</citation>
    <PMID>18772893</PMID>
  </reference>
  <reference>
    <citation>Nahar B, Hossain MI, Hamadani JD, Ahmed T, Huda SN, Grantham-McGregor SM, Persson LA. Effects of a community-based approach of food and psychosocial stimulation on growth and development of severely malnourished children in Bangladesh: a randomised trial. Eur J Clin Nutr. 2012 Jun;66(6):701-9. doi: 10.1038/ejcn.2012.13. Epub 2012 Feb 22.</citation>
    <PMID>22353925</PMID>
  </reference>
  <reference>
    <citation>Munoz M, Bayona J, Sanchez E, Arevalo J, Sebastian JL, Arteaga F, Guerra D, Zeladita J, Espiritu B, Wong M, Caldas A, Shin S. Matching social support to individual needs: a community-based intervention to improve HIV treatment adherence in a resource-poor setting. AIDS Behav. 2011 Oct;15(7):1454-64. doi: 10.1007/s10461-010-9697-9.</citation>
    <PMID>20383572</PMID>
  </reference>
  <reference>
    <citation>Caldwell, B. and R. Bradley, eds. Home Inventory Administration Manual. 3rd Edition ed. 2001, University of Arkansas at Little Rock: Little Rock, AR.</citation>
  </reference>
  <reference>
    <citation>Schreiner, M., Progress out of Poverty Index: A Simple Poverty Score for Peru. 2008, Grameen Foundation: St Louis, MO.</citation>
  </reference>
  <reference>
    <citation>Fernald LC, Kariger P, Hidrobo M, Gertler PJ. Socioeconomic gradients in child development in very young children: evidence from India, Indonesia, Peru, and Senegal. Proc Natl Acad Sci U S A. 2012 Oct 16;109 Suppl 2(Suppl 2):17273-80. doi: 10.1073/pnas.1121241109. Epub 2012 Oct 8.</citation>
    <PMID>23045688</PMID>
  </reference>
  <reference>
    <citation>Rodriquez, S., ed. Escala de evaluacion del desarollo psicomotor: 0 a 24 meses. 12th ed ed. 1996, Galdoc: Santiago, Chile.</citation>
  </reference>
  <reference>
    <citation>Engle PL, Black MM, Behrman JR, Cabral de Mello M, Gertler PJ, Kapiriri L, Martorell R, Young ME; International Child Development Steering Group. Strategies to avoid the loss of developmental potential in more than 200 million children in the developing world. Lancet. 2007 Jan 20;369(9557):229-42. doi: 10.1016/S0140-6736(07)60112-3.</citation>
    <PMID>17240290</PMID>
  </reference>
  <reference>
    <citation>Lu C, Black MM, Richter LM. Risk of poor development in young children in low-income and middle-income countries: an estimation and analysis at the global, regional, and country level. Lancet Glob Health. 2016 Dec;4(12):e916-e922. doi: 10.1016/S2214-109X(16)30266-2. Epub 2016 Oct 4.</citation>
    <PMID>27717632</PMID>
  </reference>
  <reference>
    <citation>Becares L, Nazroo J, Kelly Y. A longitudinal examination of maternal, family, and area-level experiences of racism on children's socioemotional development: Patterns and possible explanations. Soc Sci Med. 2015 Oct;142:128-35. doi: 10.1016/j.socscimed.2015.08.025. Epub 2015 Aug 15.</citation>
    <PMID>26301485</PMID>
  </reference>
  <reference>
    <citation>Hanson JL, Chandra A, Wolfe BL, Pollak SD. Association between income and the hippocampus. PLoS One. 2011 May 4;6(5):e18712. doi: 10.1371/journal.pone.0018712.</citation>
    <PMID>21573231</PMID>
  </reference>
  <reference>
    <citation>Luby J, Belden A, Botteron K, Marrus N, Harms MP, Babb C, Nishino T, Barch D. The effects of poverty on childhood brain development: the mediating effect of caregiving and stressful life events. JAMA Pediatr. 2013 Dec;167(12):1135-42. doi: 10.1001/jamapediatrics.2013.3139.</citation>
    <PMID>24165922</PMID>
  </reference>
  <reference>
    <citation>Garner AS. Home visiting and the biology of toxic stress: opportunities to address early childhood adversity. Pediatrics. 2013 Nov;132 Suppl 2:S65-73. doi: 10.1542/peds.2013-1021D.</citation>
    <PMID>24187125</PMID>
  </reference>
  <reference>
    <citation>Grantham-McGregor SM, Powell CA, Walker SP, Himes JH. Nutritional supplementation, psychosocial stimulation, and mental development of stunted children: the Jamaican Study. Lancet. 1991 Jul 6;338(8758):1-5. doi: 10.1016/0140-6736(91)90001-6.</citation>
    <PMID>1676083</PMID>
  </reference>
  <reference>
    <citation>Munoz M, Nelson A, Johnson M, Godoy N, Serrano E, Chagua E, Valdivia J, Santacruz J, Wong M, Kolevic L, Kammerer B, Vega C, Vibbert M, Lundy S, Shin S. Community-Based Needs Assessment of Neurodevelopment, Caregiver, and Home Environment Factors in Young Children Affected by HIV in Lima, Peru. J Int Assoc Provid AIDS Care. 2017 Mar/Apr;16(2):161-167. doi: 10.1177/2325957416631625. Epub 2016 Jul 8.</citation>
    <PMID>26917559</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Adrianne Katrina Hart Nelson</investigator_full_name>
    <investigator_title>Research Manager</investigator_title>
  </responsible_party>
  <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/NCT03010306
org study id: 2013P002554
nct id: NCT03010306
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Building on an intervention for early child development from the SPARK Center in Boston,
      Socios En Salud (SES) pilot tested "CASITA" a community-based package to screen and treat
      young children (ages 1-3 years of age) diagnosed with neurodevelopment risk and delay in
      Carabayllo, Lima, Peru. Ministry of Health CHWs identified children with developmental delays
      within the clinics and community and delivered a structured early intervention that included
      parent coaching and social support. In order to test the hypothesis that CASITA improves
      early child development, caregiver, and home environment, dyads received either nutrition
      supplements alone, nutrition + "CASITA" early child development sessions individually, or
      CASITA in a group of 10 dyads.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in risk of delay, as measured by the EASQ
time frame: baseline, 3 months
description: The Ages and Stages Questionnaire (ASQ) is an internationally-validated instrument that can be used to assess change in developmental risk over time. Fernald et al incorporated additional observation-based assessments and the following modifications: 1) addition of child observation exercises to allow for validity check of parent responses (original ASQ questions), and 2) the incorporation of ASQ questions from the next highest age range. The Extended Ages and Stages Questionnaire (EASQ) was utilized as an assessment tool to allow us to better quantify degree of risk at baseline (based on quintiles of scores). By incorporating ASQ questions from the next two highest age ranges, scores will be continuous across the study period of three. The EASQ has been applied to children in four countries, including 2,845 children in Peru.
measure: Change in global HOME score
time frame: baseline, 3 months
description: The Infant Toddler Home Observation Measurement of the Environment (HOME) evaluates parenting and home influences on child development.
measure: Change in HOME subscore of parent responsivity
time frame: baseline, 3 months
description: This HOME subscore is defined in the manual as "the extent to which the parent responds to the child's behavior including reinforcement for desired behavior and communication through words and actions".
measure: Change in HOME subscore of parent involvement
time frame: baseline, 3 months
description: This HOME subscore is defined as "parental acceptance of the child's behavior that is less than optimal and examines avoidance of undue restriction and punishment".
arm group label: Nutrition only
arm group type: No Intervention
description: Monthly food baskets were provided to the nutrition only group. Food baskets included basic foods to sustain a family of three over one month's time, such as rice and evaporated milk. Food baskets were valued at approximately $28 US Dollars per basket.
arm group label: Nutrition + CASITA
arm group type: Active Comparator
description: The CASITA intervention was given by a community health worker (CHW) and involves individual and group modalities. HOME-CASITA took place at the dyad's place of residence, and the GROUP-CASITA at a local community center. All CASITA participants received 12 weekly sessions over 3 months. Interventions retain core elements of the SPARK approach: coaching parents on child development stimulation and providing social support and encouragement. Each session is as follows: 1) Child observation & knowledge sharing about child development; 2) Practice of reciprocal attention focusing and social interaction activities; 3) Parent encouragement on behavior and developmental interactions; and 4) Parent social support through referral assistance, reassurance, and validation of parent's concerns.
intervention type: Other
intervention name: CASITA
arm group label: Nutrition + CASITA
other name: Child development coaching and social support in Lima Peru
other name: Community-based intervention for children at risk of Neurodevelopment delay
criteria: 
gender: All
minimum age: 6 Months
maximum age: 24 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Leonid Lecca, MD
role: Principal Investigator
affiliation: Socios En Salud, Peru
url: http://www.grandchallenges.ca/grantee-stars/0769-05/
description: CASITA scale-up: Grand Challenges Canada
url: http://www.savingbrainsinnovation.net/projects/0769-05/
description: CASITA scale-up: Saving Brains Innovation
url: https://issuu.com/sociosensalud/docs/early_childhood_development_newslet
description: Early Child Development Working Group (Harvard Medical School): Field Feature CASITA
citation: Grantham-McGregor S, Cheung YB, Cueto S, Glewwe P, Richter L, Strupp B; International Child Development Steering Group. Developmental potential in the first 5 years for children in developing countries. Lancet. 2007 Jan 6;369(9555):60-70. doi: 10.1016/S0140-6736(07)60032-4.
PMID: 17208643
citation: Nahar B, Hamadani JD, Ahmed T, Tofail F, Rahman A, Huda SN, Grantham-McGregor SM. Effects of psychosocial stimulation on growth and development of severely malnourished children in a nutrition unit in Bangladesh. Eur J Clin Nutr. 2009 Jun;63(6):725-31. doi: 10.1038/ejcn.2008.44. Epub 2008 Sep 3.
PMID: 18772893
citation: Nahar B, Hossain MI, Hamadani JD, Ahmed T, Huda SN, Grantham-McGregor SM, Persson LA. Effects of a community-based approach of food and psychosocial stimulation on growth and development of severely malnourished children in Bangladesh: a randomised trial. Eur J Clin Nutr. 2012 Jun;66(6):701-9. doi: 10.1038/ejcn.2012.13. Epub 2012 Feb 22.
PMID: 22353925
citation: Munoz M, Bayona J, Sanchez E, Arevalo J, Sebastian JL, Arteaga F, Guerra D, Zeladita J, Espiritu B, Wong M, Caldas A, Shin S. Matching social support to individual needs: a community-based intervention to improve HIV treatment adherence in a resource-poor setting. AIDS Behav. 2011 Oct;15(7):1454-64. doi: 10.1007/s10461-010-9697-9.
PMID: 20383572
citation: Caldwell, B. and R. Bradley, eds. Home Inventory Administration Manual. 3rd Edition ed. 2001, University of Arkansas at Little Rock: Little Rock, AR.
citation: Schreiner, M., Progress out of Poverty Index: A Simple Poverty Score for Peru. 2008, Grameen Foundation: St Louis, MO.
citation: Fernald LC, Kariger P, Hidrobo M, Gertler PJ. Socioeconomic gradients in child development in very young children: evidence from India, Indonesia, Peru, and Senegal. Proc Natl Acad Sci U S A. 2012 Oct 16;109 Suppl 2(Suppl 2):17273-80. doi: 10.1073/pnas.1121241109. Epub 2012 Oct 8.
PMID: 23045688
citation: Rodriquez, S., ed. Escala de evaluacion del desarollo psicomotor: 0 a 24 meses. 12th ed ed. 1996, Galdoc: Santiago, Chile.
citation: Engle PL, Black MM, Behrman JR, Cabral de Mello M, Gertler PJ, Kapiriri L, Martorell R, Young ME; International Child Development Steering Group. Strategies to avoid the loss of developmental potential in more than 200 million children in the developing world. Lancet. 2007 Jan 20;369(9557):229-42. doi: 10.1016/S0140-6736(07)60112-3.
PMID: 17240290
citation: Lu C, Black MM, Richter LM. Risk of poor development in young children in low-income and middle-income countries: an estimation and analysis at the global, regional, and country level. Lancet Glob Health. 2016 Dec;4(12):e916-e922. doi: 10.1016/S2214-109X(16)30266-2. Epub 2016 Oct 4.
PMID: 27717632
citation: Becares L, Nazroo J, Kelly Y. A longitudinal examination of maternal, family, and area-level experiences of racism on children's socioemotional development: Patterns and possible explanations. Soc Sci Med. 2015 Oct;142:128-35. doi: 10.1016/j.socscimed.2015.08.025. Epub 2015 Aug 15.
PMID: 26301485
citation: Hanson JL, Chandra A, Wolfe BL, Pollak SD. Association between income and the hippocampus. PLoS One. 2011 May 4;6(5):e18712. doi: 10.1371/journal.pone.0018712.
PMID: 21573231
citation: Luby J, Belden A, Botteron K, Marrus N, Harms MP, Babb C, Nishino T, Barch D. The effects of poverty on childhood brain development: the mediating effect of caregiving and stressful life events. JAMA Pediatr. 2013 Dec;167(12):1135-42. doi: 10.1001/jamapediatrics.2013.3139.
PMID: 24165922
citation: Garner AS. Home visiting and the biology of toxic stress: opportunities to address early childhood adversity. Pediatrics. 2013 Nov;132 Suppl 2:S65-73. doi: 10.1542/peds.2013-1021D.
PMID: 24187125
citation: Grantham-McGregor SM, Powell CA, Walker SP, Himes JH. Nutritional supplementation, psychosocial stimulation, and mental development of stunted children: the Jamaican Study. Lancet. 1991 Jul 6;338(8758):1-5. doi: 10.1016/0140-6736(91)90001-6.
PMID: 1676083
citation: Munoz M, Nelson A, Johnson M, Godoy N, Serrano E, Chagua E, Valdivia J, Santacruz J, Wong M, Kolevic L, Kammerer B, Vega C, Vibbert M, Lundy S, Shin S. Community-Based Needs Assessment of Neurodevelopment, Caregiver, and Home Environment Factors in Young Children Affected by HIV in Lima, Peru. J Int Assoc Provid AIDS Care. 2017 Mar/Apr;16(2):161-167. doi: 10.1177/2325957416631625. Epub 2016 Jul 8.
PMID: 26917559
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Adrianne Katrina Hart Nelson
investigator title: Research Manager
sharing ipd: No