<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/NCT01672437</url>
  </required_header>
  <id_info>
    <org_study_id>Nyfødt -DP -269</org_study_id>
    <nct_id>NCT01672437</nct_id>
  </id_info>
  <brief_title>NewPreBP: Project Newborn -Preparation for Birth and Parenthood</brief_title>
  <acronym>NewPreBP</acronym>
  <official_title>NewPreBP: Project Newborn -Preparation for Birth and Parenthood. A Large Interdisciplinary Randomised Trial on the Effect of Birth and Parent Preparation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vibeke Koushede</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Copenhagen Trial Unit, Center for Clinical Intervention Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Danish Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Danish regions aim to implement antenatal education in small groups for all expectant&#xD;
      parents. The effects of general antenatal education for childbirth or parenthood, or both,&#xD;
      remain largely unknown. Also it is unknown if antenatal education in small groups is superior&#xD;
      to antenatal lectures which is currently standard care.&#xD;
&#xD;
      The aim of the trial is to evaluate if antenatal birth and parent preparation in small groups&#xD;
      can increase parenting resources thereby easing birth and creating a smoother and less&#xD;
      stressful transition to parenthood among the participants, compared to those allocated to&#xD;
      standard care. This in turn is hypothesized to improve health and thriving among newborn&#xD;
      families and affect their use of healthcare services. A thorough process evaluation will be&#xD;
      conducted highlighting enabling factors and barriers to the implementation. Finally&#xD;
      cost-effectiveness analysis will be conducted.&#xD;
&#xD;
      Individually randomised trial sited at Hvidovre Hospital, a large birth clinic in the&#xD;
      Copenhagen Capital Region of Denmark.&#xD;
&#xD;
      Participants: 1756 pregnant women ≥ 18 years old, recruited before 20+0 weeks gestation, due&#xD;
      to give birth at Hvidovre Hospital. Being legally able and willing to provide signed consent,&#xD;
      and being fluent in Danish.&#xD;
&#xD;
      Women are randomised to receive:&#xD;
&#xD;
        1. A research-based birth and parenting program. The intervention consists of 4 sessions in&#xD;
           small groups that last for 2,5 hours per session at 25, 33 and 35 weeks of gestation,&#xD;
           and a post-natal session 5 weeks after expected due date.&#xD;
&#xD;
        2. Standard care (control group). The pregnant woman and her partner are offered two&#xD;
           antenatal lectures in an auditorium.&#xD;
&#xD;
      The allocation of participants to the intervention will be 1:1 to the intervention and the&#xD;
      control group.&#xD;
&#xD;
      Data will be collected via questionnaires at baseline, 37 weeks gestation, 9 weeks&#xD;
      post-partum, 6 months post-partum and 1 year post-partum, via the hospital obstetric&#xD;
      database, and via the national registers. Analyses will be intention to treat. Subgroup&#xD;
      analysis will be conducted in relation to personal and demographic characteristics. Process&#xD;
      evaluation will be conducted using questionnaires and qualitative interviews. The incremental&#xD;
      societal cost of the intervention will be computed and compared to the measured outcomes in a&#xD;
      cost-effectiveness analysis.&#xD;
&#xD;
      Outcomes: Stress, parenting alliance, depressive symptoms, wellbeing obstetric intervention,&#xD;
      use of health care services, self-efficacy, divorce.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Antenatal education Today Danish antenatal classes are primarily offered in auditoriums as&#xD;
      lectures with a minimum of interaction with the audience. The Danish regions currently aim in&#xD;
      time to implement antenatal birth and parent preparation classes in small groups for all&#xD;
      expectant parents. However, it is unknown if 1) antenatal preparation in small groups is&#xD;
      superior to standard care; 2) what elements the preparation should encompass to meet the&#xD;
      needs of expectant parents today; and 3) what the cost-effectiveness of antenatal preparation&#xD;
      in small groups is compared to large-scale preparation in auditoriums.&#xD;
&#xD;
      Trial objectives and purpose The primary aim is to compare parenting resources, health and&#xD;
      thriving, and use of healthcare services in newborn families enrolled in a research-based&#xD;
      standardised antenatal birth and parenting program in small groups with those allocated to&#xD;
      standard care.&#xD;
&#xD;
      Development of the program: We have developed a comprehensive, theoretically founded&#xD;
      parenting program in collaboration with midwives, health care visitors, a psychologist and&#xD;
      family therapist, parents, and leading national and international researchers and clinicians&#xD;
      in this field.&#xD;
&#xD;
      Process evaluation: Focus group interviews with service providers, group facilitators and&#xD;
      participants will be carried out. Program fidelity e.g. whether the protocol is followed in&#xD;
      program delivery, and how much of the intended program the participants are receiving, as&#xD;
      well as program reach e.g. what proportions of the intended groups are participating in the&#xD;
      program, has an impact on the effect of an intervention. We will evaluate whether the&#xD;
      protocol is followed in program delivery and how much of the intended program the&#xD;
      participants are receiving. Participants will be asked to fill in an electronic questionnaire&#xD;
      on-site at the end of each session. The questionnaire will highlight whether the intended&#xD;
      subjects of the session have been covered as well as to what extent the participants found&#xD;
      the information given useful. Group facilitators will be asked to fill in a similar&#xD;
      questionnaire with the opportunity to explain why certain topics may have been omitted.&#xD;
&#xD;
      Non respondent/non-participation: What proportions of the intended groups are participating&#xD;
      in the program will be explored by examining demographic characteristics of those who&#xD;
      declined to participate in the trial via the national registers, as well as examining&#xD;
      characteristics of those who accepted and then did or did not show up for the sessions.&#xD;
&#xD;
      Cost-effectiveness analysis: Finally the incremental societal cost of the intervention will&#xD;
      be calculated and compared to the measured outcomes in a cost-effectiveness analysis. Direct&#xD;
      health care costs as well as productivity costs in terms of labour market participation and&#xD;
      sickness absence. For this we will use data from the obstetric database at Hvidovre Hospital,&#xD;
      national registers and questionnaires.&#xD;
&#xD;
      Trial design Individually randomised trial sited at a large birth clinic in the Copenhagen&#xD;
      Capital Region, Hvidovre Hospital.&#xD;
&#xD;
      Trial intervention&#xD;
&#xD;
      The intervention will have two arms:&#xD;
&#xD;
        1. A research-based parenting program described in more detail below.&#xD;
&#xD;
        2. Standard care (control group). The pregnant woman and her partner are offered two&#xD;
           antenatal lectures on birth and breastfeeding in an auditorium.&#xD;
&#xD;
      The intervention arm: Groups of approximately 6-7 couples (or mothers) will meet three times&#xD;
      during pregnancy and 1 time 5 weeks after expected due date, for the duration of 2.5 hours&#xD;
      per session. (The aim is to create groups of 6-7 couples; however, due to fluctuations in&#xD;
      uptake groups of 4-9 couples will be deemed acceptable). The sessions will include&#xD;
      information and discussions about emotions and expectations related to birth and parenting,&#xD;
      identification of social network resources, couple communication, breastfeeding, parent-child&#xD;
      attachment, directions on taking care of a newborn, and recognising common signs of mood&#xD;
      disorders and how to react. A website with parenting information and exercises will be&#xD;
      created and parents will be encouraged to use this material alongside the sessions. In&#xD;
      addition to gaining knowledge about issues related to birth and parenting, and creating an&#xD;
      environment where parents can discuss their feelings and concerns, the program aims at&#xD;
      enhancing expectant parents' awareness of their own resources and problem-solving strategies.&#xD;
      Furthermore the way the groups are composited will enable participants to establish relations&#xD;
      with other expectant parents in their local area. All sessions will be led by a midwife. The&#xD;
      postnatal session will be conducted in collaboration with a health visitor, to increase&#xD;
      knowledge on available resources in the local communities Informed consent All participants&#xD;
      considered for this trial will be provided with written and oral information on this trial so&#xD;
      that participants can make an informed decision about their participation in this trial. A&#xD;
      project phone line will be established where participants can contact a project member&#xD;
      throughout the trial if she has further questions, or wishes to withdraw her consent for&#xD;
      participation in the trial.&#xD;
&#xD;
      Data collection Data will be collected from both parents using web-based questionnaires at:&#xD;
      baseline (approximately 18 weeks gestation) (Tp0), 37 weeks gestation (Tp1), 9 weeks after&#xD;
      expected due date (Tp2), 6 months after expected due date (Tp3), 1 year after expected due&#xD;
      date (Tp4). Participants will be contacted via e-mail, when due to answer a questionnaire.&#xD;
      Two reminders will be sent via additional e-mails, the first after a week and the second&#xD;
      after 14 days. Data will also be obtained from the hospital obstetric database and the&#xD;
      national registers.&#xD;
&#xD;
      Concomitant medication/treatment All participants are free to make use of concomitant&#xD;
      antenatal/postnatal services and parent groups. As use of other services and parent groups&#xD;
      may influence the outcomes that we are interested in, use and services will be examined,&#xD;
      documented and given careful consideration in the analyses.&#xD;
&#xD;
      Explorative outcomes&#xD;
&#xD;
      In addition to primary and secondary outcomes, there are following explorative outcomes:&#xD;
&#xD;
      Post-natal depressive symptomatology and anxiety - questionnaire data, EPDS (tp0,1,2)&#xD;
      Breastfeeding - questionnaire data (tp0,1,2,3) Use of healthcare services i.e.: for the&#xD;
      parents obstetric intervention i.e. augmentation of labour, vacuum extraction, caesarean rate&#xD;
      - data from the hospital obstetric database (tp2), and contact to healthcare professionals&#xD;
      for depressive symptomatology and unscheduled postnatal visits- questionnaire data (tp2,3).&#xD;
&#xD;
      Family medicine use - questionnaire data (tp2,3) and register data (tp4) Smoking -&#xD;
      questionnaire data (tp1,2,3,4) Satisfaction with relationship and family break-ups -&#xD;
      questionnaire data (tp 0,1,2,3,4), and data from the national registers on divorce and&#xD;
      break-ups (tp4): mental well-being (tp1,2,3,4)&#xD;
&#xD;
      In this trial the intermediate outcomes of interest are:&#xD;
&#xD;
      Parenting resources: trust in own ability to cope with: 1) birth (tp1), 2) discharge (tp1) 3)&#xD;
      parenting (tp1,2,4) breastfeeding (tp0,1); couple communication (tp0,1,2,3,4); social&#xD;
      support/network (tp0,1,2,3,4) Statistical plan and data analysis Sample size and power&#xD;
      estimations We are planning a trial of independent experimental and control participant with&#xD;
      1 control per experimental participant. 2011 data from the HH Obstetric Database (unpublished&#xD;
      data) indicate that epidural use among pregnant women is 31%. If the true epidural use for&#xD;
      experimental participants is 25%, we will need to include 1,175 experimental participants and&#xD;
      1,175 control participants be able to reject the null hypothesis that the epidural use for&#xD;
      experimental and control participants are equal with probability (power) 90%. The Type I&#xD;
      error probability associated with this test of this null hypothesis is 5% Amendment 17th&#xD;
      February 2014: Due to slow recruitment, we reduce the power from 90% to 80%, thus reducing&#xD;
      the sample size from 2,350 participants to 1,756 participants.&#xD;
&#xD;
      Power estimation for the secondary outcome Perceived Stress Scale We are planning a trial&#xD;
      with 1175 experimental participants and 1175 control participants. In a previous study the&#xD;
      Perceived Stress Scale response within each participant group was normally distributed with&#xD;
      standard deviation 6 (18). If the true difference in the experimental and control means is 1,&#xD;
      we will be able to reject the null hypothesis that the population means of the experimental&#xD;
      and control groups are equal with probability (power) 98.1%. The type 1 error probability&#xD;
      associated with this test of this null hypothesis is 0.5.&#xD;
&#xD;
      Power estimation for the secondary outcome Swedish Parenthood Stress Questionnaire In a&#xD;
      previous study the Swedish Parenthood Stress Questionnaire response within each subject group&#xD;
      was normally distributed with standard deviation 0.5 (19). If the true difference in the&#xD;
      experimental and control means is 0.1, we will be able to reject the null hypothesis that the&#xD;
      population means of the experimental and control groups are equal with probability (power)&#xD;
      99.8%. The type 1 error probability associated with this test of this null hypothesis is 0.5.&#xD;
&#xD;
      Power estimation for the secondary outcome Parenting Alliance Measure In a previous study the&#xD;
      Parenting Alliance Measure response within each subject group was normally distributed with&#xD;
      standard deviation 20. If the true difference in the experimental and control means is 4, we&#xD;
      will be able to reject the null hypothesis that the population means of the experimental and&#xD;
      control groups are equal with probability (power) 98.7%. The type 1 error probability&#xD;
      associated with this test of this null hypothesis is 5%.&#xD;
&#xD;
      Statistical methods Reporting will follow the guidelines of the CONSORT-statement.&#xD;
      Statistical analyses will be intention to treat as well as per protocol. The level of&#xD;
      significance will be 0.05.&#xD;
&#xD;
      The analysis of the primary binary outcome will be done using logistic regression.&#xD;
&#xD;
      The results of this analysis will be subjected to a worst case and a best case scenario&#xD;
      analysis of the potential impact of missing values. In the analysis of the two secondary&#xD;
      outcome measures a mixed model with repeated measures will be used. The fixed effects will&#xD;
      include a linear and a quadratic time component and their corresponding interactions with the&#xD;
      intervention indicator. An unstructured covariance matrix will be used initially. If&#xD;
      convergence cannot be obtained the spatial power law covariance structure will be tried and&#xD;
      then the compound symmetric model.&#xD;
&#xD;
      Using the general linear univariate model it will be tested if the mean values differ between&#xD;
      the two intervention groups at time 1 (9 weeks following birth).&#xD;
&#xD;
      If the assumptions of the above analyses cannot be fulfilled with reasonable approximation&#xD;
      the groups will only be compared at time 1 using a nonparametric test (Mann Whitney).&#xD;
&#xD;
      The unadjusted analyses are the primary analyses. If possible all analyses will be repeated&#xD;
      adjusted for the protocol specified stratification variable and the baseline value.&#xD;
&#xD;
      Three explorative subgroup analyses may be conducted in each case provided the subgroup&#xD;
      interacts significantly with the intervention.&#xD;
&#xD;
      Dealing with multiplicity, gate keeping will be used to adjust the observed p values for&#xD;
      primary and secondary outcomes. Both observed and adjusted p values will be reported.&#xD;
&#xD;
      Direct access to source data/documentation&#xD;
&#xD;
      The trial will be carried out in accordance with the Declaration of Helsinki in its latest&#xD;
      form as well as national laws and regulations. The investigators permit audits and inspection&#xD;
      by providing direct access to source data/documentation. The trial will be monitored by an&#xD;
      unrelated research group at the National Institute of Public Health. eCRFs will be checked,&#xD;
      and as minimum the following will be monitored locally:&#xD;
&#xD;
      All patients for existence (If the CPR number is correct), All patients for documented&#xD;
      informed consent&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2014</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Epidural use</measure>
    <time_frame>during labour</time_frame>
    <description>Epidural use during will be measured using data from the hospital obstetric database</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceived stress</measure>
    <time_frame>baseline, 37 weeks gestation, 9 weeks post-partum, 6 months post-partum, 1 year post-partum</time_frame>
    <description>The perceived stress scale (PSS) will be used to measure global levels of perceived stress. The PSS takes into account the individual's ability to cope. The scale was developed on the basis of appraisal theory and was designed to tap the degree to which respondents found their lives unpredictable, uncontrollable, and overloading.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting stress</measure>
    <time_frame>9 weeks post-partum, 6 months post-partum, 1 year post-partum</time_frame>
    <description>Parenting stress will be measured using the Swedish Parenthood Stress Questionnaire (SPSQ) translated into Danish. The scale takes into account the individual's ability to cope and assesses parental stress with a sum score and subscale scores of incompetence, role restriction, social isolation, spouse relationship and health problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting alliance</measure>
    <time_frame>6 months post-partum, 1 year post-partum</time_frame>
    <description>Parenting alliance will be measured by the Parenting Alliance Measure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1766</enrollment>
  <condition>Stress</condition>
  <condition>Depression</condition>
  <condition>Communication</condition>
  <condition>Self-efficacy</condition>
  <condition>Coping</condition>
  <arm_group>
    <arm_group_label>Birth and parent preparation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The following subjects will be covered in the sessions:&#xD;
Session 1 (25 weeks gestation):&#xD;
Common challenges in the transition to parenthood and in the relationship&#xD;
Couple communication&#xD;
Session 2 (33 weeks gestation):&#xD;
Expectations in relation to birth&#xD;
The normal course of labour&#xD;
Obstetric intervention&#xD;
Pain relief,coping strategies&#xD;
Partner support&#xD;
Session 3 (35 weeks gestation):&#xD;
Feeding a newborn&#xD;
Interpreting the newborn's signs, symptoms and behaviour&#xD;
Taking care of a newborn&#xD;
Mood swings, postnatal depressive symptomatology&#xD;
Session 4 (5 weeks post-partum):&#xD;
Birth experiences&#xD;
Mood swings, postnatal depressive symptomatology&#xD;
The first time at home with a newborn&#xD;
Couplehood - partner support, communication, division of household tasks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group are offered two lectures in an auditorium during pregnancy - one on breastfeeding and one on labour. This is standard care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Birth and parent preparation</intervention_name>
    <description>4 sessions of birth and parent preparation in small groups of 6-8 couples. 3 sessions during pregnancy, 1 session following birth.</description>
    <arm_group_label>Birth and parent preparation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Expectant pregnant women (and partners)&#xD;
&#xD;
          -  ≥ 18 years old&#xD;
&#xD;
          -  Due to give birth at Hvidovre Hospital, Denmark&#xD;
&#xD;
          -  Able to speak and understand Danish&#xD;
&#xD;
          -  Being legally able and willing to provide signed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not providing signed informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pernille Due, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Southern Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vibeke Koushede, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christian Gluud, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Copenhagen Trial Unit, Center for Clinical Intervention Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Morten Grønbæk, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Southern Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hvidovre Hospital</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Barlow J, Parsons J. Group-based parent-training programmes for improving emotional and behavioural adjustment in 0-3 year old children. Cochrane Database Syst Rev. 2003;(1):CD003680. doi: 10.1002/14651858.CD003680.</citation>
    <PMID>12535483</PMID>
  </reference>
  <reference>
    <citation>Abidin RR. The Determinants of Parenting Behavior. Journal of Clinical Child Psychology 1992 Dec;21(4):407-12.</citation>
  </reference>
  <reference>
    <citation>Cowan CP, Cowan PA. When partners become parents: The big life change for couples. Mahwah NJ: Lawrence Erlbaum Associates Publishers; 2000.</citation>
  </reference>
  <reference>
    <citation>Assel MA, Landry SH, Swank PR, Steelman L, Miller-Loncar C, Smith KE. How do mothers' childrearing histories, stress and parenting affect children's behavioural outcomes? Child Care Health Dev. 2002 Sep;28(5):359-68. doi: 10.1046/j.1365-2214.2002.00285.x.</citation>
    <PMID>12296871</PMID>
  </reference>
  <reference>
    <citation>Benzies KM, Harrison MJ, Magill-Evans J. Parenting stress, marital quality, and child behavior problems at age 7 years. Public Health Nurs. 2004 Mar-Apr;21(2):111-21. doi: 10.1111/j.0737-1209.2004.021204.x.</citation>
    <PMID>14987210</PMID>
  </reference>
  <reference>
    <citation>Deater-Deckard K. Parenting stress and child adjustment: Some old hypotheses and new questions. Clinical Psychology-Science and Practice 1998;5(3):314-32</citation>
  </reference>
  <reference>
    <citation>Nystrom K, Ohrling K. Parenthood experiences during the child's first year: literature review. J Adv Nurs. 2004 May;46(3):319-30. doi: 10.1111/j.1365-2648.2004.02991.x.</citation>
    <PMID>15066113</PMID>
  </reference>
  <reference>
    <citation>Schor EL; American Academy of Pediatrics Task Force on the Family. Family pediatrics: report of the Task Force on the Family. Pediatrics. 2003 Jun;111(6 Pt 2):1541-71.</citation>
    <PMID>12777595</PMID>
  </reference>
  <reference>
    <citation>Deater-Deckard K, Pinkerton R, Scarr S. Child care quality and children's behavioral adjustment: a four-year longitudinal study. J Child Psychol Psychiatry. 1996 Nov;37(8):937-48. doi: 10.1111/j.1469-7610.1996.tb01491.x.</citation>
    <PMID>9119941</PMID>
  </reference>
  <reference>
    <citation>National Board of Health D. Status on regional and municipal offers in relation to pregnancy and delivery with focus on delivery and early discharge ( In Danish: Status for regionernes og kommunernes tilbud til gravide og fødende med fokus på ambulante fødsler og tidlige udskrivelser). Copenhagen: National Board of Health, Denmark; 2011. Report No.: j.nr. 7-205-03-31/1/chb.</citation>
  </reference>
  <reference>
    <citation>Gagnon AJ. Individual or group antenatal education for childbirth/parenthood. Cochrane Database Syst Rev. 2000;(4):CD002869. doi: 10.1002/14651858.CD002869.</citation>
    <PMID>11034780</PMID>
  </reference>
  <reference>
    <citation>Dunkley J. Health promotion in midwifery practise: a resource for health professionals. Edinburgh: Bailliere Tindall; 2000.</citation>
  </reference>
  <reference>
    <citation>Biro MA. What has public health got to do with midwifery? Midwives' role in securing better health outcomes for mothers and babies. Women Birth. 2011 Mar;24(1):17-23. doi: 10.1016/j.wombi.2010.06.001. Epub 2010 Jul 2.</citation>
    <PMID>20598666</PMID>
  </reference>
  <reference>
    <citation>Brot C, Poulsen A. Recommendations in relation to antenatal care 2009 (In Danish: Anbefalinger for svangreomsorgen 2009). Copenhagen: National Board of Health, Denmark; 2009.</citation>
  </reference>
  <reference>
    <citation>Haggman-Laitila A, Pietila AM. Perceived benefits on family health of small groups for families with children. Public Health Nurs. 2007 May-Jun;24(3):205-16. doi: 10.1111/j.1525-1446.2007.00627.x.</citation>
    <PMID>17456122</PMID>
  </reference>
  <reference>
    <citation>Barlow J, Coren E. Parent-training programmes for improving maternal psychosocial health. Cochrane Database Syst Rev. 2004;(1):CD002020. doi: 10.1002/14651858.CD002020.pub2.</citation>
    <PMID>14973981</PMID>
  </reference>
  <reference>
    <citation>Sanders MR. Triple P-Positive Parenting Program as a public health approach to strengthening parenting. J Fam Psychol. 2008 Aug;22(4):506-17. doi: 10.1037/0893-3200.22.3.506. Erratum In: J Fam Psychol. 2015 Feb;29(1):38.</citation>
    <PMID>18729665</PMID>
  </reference>
  <reference>
    <citation>Nutbeam D, Kickbusch I. Advancing health literacy: a global challenge for the 21st century. Health Promotion International 2000 Sep;15(3):183-4.</citation>
  </reference>
  <reference>
    <citation>Illeris K, Jarvis P, Kegan R, Engeström Y, Elkjaer B, Mezirow J, et al. Contemporary Theories of Learning: Learning Theorists...in their own words. New York: Routledge; 2009.</citation>
  </reference>
  <reference>
    <citation>Bartholomew L.K, Parcel G.S, Kok G, Gottlieb N.H, Fernández M.E. Planning Health Promotion Programs - An intervention mapping approach. 3 rd ed. San Francisco: Jossey-Bass; 2011.</citation>
  </reference>
  <reference>
    <citation>Whittakar KA, Cowley S. An effective programme is not enough: a review of factors associated with poor attendance and engagement with parenting support programmes. Children and Society 2010.</citation>
  </reference>
  <reference>
    <citation>Milgrom J, Schembri C, Ericksen J, Ross J, Gemmill AW. Towards parenthood: an antenatal intervention to reduce depression, anxiety and parenting difficulties. J Affect Disord. 2011 May;130(3):385-94. doi: 10.1016/j.jad.2010.10.045. Epub 2010 Nov 26.</citation>
    <PMID>21112641</PMID>
  </reference>
  <reference>
    <citation>Ostberg M, Hagekull B, Wettergren S. A measure of parental stress in mothers with small children: dimensionality, stability and validity. Scand J Psychol. 1997 Sep;38(3):199-208. doi: 10.1111/1467-9450.00028.</citation>
    <PMID>9309950</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Vibeke Koushede</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Birth and parent preparation</keyword>
  <keyword>Parenting stress</keyword>
  <keyword>Depression</keyword>
  <keyword>self-efficacy</keyword>
  <keyword>social network and support</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT01672437
org study id: Nyfødt -DP -269
nct id: NCT01672437
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The Danish regions aim to implement antenatal education in small groups for all expectant
      parents. The effects of general antenatal education for childbirth or parenthood, or both,
      remain largely unknown. Also it is unknown if antenatal education in small groups is superior
      to antenatal lectures which is currently standard care.

      The aim of the trial is to evaluate if antenatal birth and parent preparation in small groups
      can increase parenting resources thereby easing birth and creating a smoother and less
      stressful transition to parenthood among the participants, compared to those allocated to
      standard care. This in turn is hypothesized to improve health and thriving among newborn
      families and affect their use of healthcare services. A thorough process evaluation will be
      conducted highlighting enabling factors and barriers to the implementation. Finally
      cost-effectiveness analysis will be conducted.

      Individually randomised trial sited at Hvidovre Hospital, a large birth clinic in the
      Copenhagen Capital Region of Denmark.

      Participants: 1756 pregnant women ≥ 18 years old, recruited before 20+0 weeks gestation, due
      to give birth at Hvidovre Hospital. Being legally able and willing to provide signed consent,
      and being fluent in Danish.

      Women are randomised to receive:

        1. A research-based birth and parenting program. The intervention consists of 4 sessions in
           small groups that last for 2,5 hours per session at 25, 33 and 35 weeks of gestation,
           and a post-natal session 5 weeks after expected due date.

        2. Standard care (control group). The pregnant woman and her partner are offered two
           antenatal lectures in an auditorium.

      The allocation of participants to the intervention will be 1:1 to the intervention and the
      control group.

      Data will be collected via questionnaires at baseline, 37 weeks gestation, 9 weeks
      post-partum, 6 months post-partum and 1 year post-partum, via the hospital obstetric
      database, and via the national registers. Analyses will be intention to treat. Subgroup
      analysis will be conducted in relation to personal and demographic characteristics. Process
      evaluation will be conducted using questionnaires and qualitative interviews. The incremental
      societal cost of the intervention will be computed and compared to the measured outcomes in a
      cost-effectiveness analysis.

      Outcomes: Stress, parenting alliance, depressive symptoms, wellbeing obstetric intervention,
      use of health care services, self-efficacy, divorce.
Antenatal education Today Danish antenatal classes are primarily offered in auditoriums as
      lectures with a minimum of interaction with the audience. The Danish regions currently aim in
      time to implement antenatal birth and parent preparation classes in small groups for all
      expectant parents. However, it is unknown if 1) antenatal preparation in small groups is
      superior to standard care; 2) what elements the preparation should encompass to meet the
      needs of expectant parents today; and 3) what the cost-effectiveness of antenatal preparation
      in small groups is compared to large-scale preparation in auditoriums.

      Trial objectives and purpose The primary aim is to compare parenting resources, health and
      thriving, and use of healthcare services in newborn families enrolled in a research-based
      standardised antenatal birth and parenting program in small groups with those allocated to
      standard care.

      Development of the program: We have developed a comprehensive, theoretically founded
      parenting program in collaboration with midwives, health care visitors, a psychologist and
      family therapist, parents, and leading national and international researchers and clinicians
      in this field.

      Process evaluation: Focus group interviews with service providers, group facilitators and
      participants will be carried out. Program fidelity e.g. whether the protocol is followed in
      program delivery, and how much of the intended program the participants are receiving, as
      well as program reach e.g. what proportions of the intended groups are participating in the
      program, has an impact on the effect of an intervention. We will evaluate whether the
      protocol is followed in program delivery and how much of the intended program the
      participants are receiving. Participants will be asked to fill in an electronic questionnaire
      on-site at the end of each session. The questionnaire will highlight whether the intended
      subjects of the session have been covered as well as to what extent the participants found
      the information given useful. Group facilitators will be asked to fill in a similar
      questionnaire with the opportunity to explain why certain topics may have been omitted.

      Non respondent/non-participation: What proportions of the intended groups are participating
      in the program will be explored by examining demographic characteristics of those who
      declined to participate in the trial via the national registers, as well as examining
      characteristics of those who accepted and then did or did not show up for the sessions.

      Cost-effectiveness analysis: Finally the incremental societal cost of the intervention will
      be calculated and compared to the measured outcomes in a cost-effectiveness analysis. Direct
      health care costs as well as productivity costs in terms of labour market participation and
      sickness absence. For this we will use data from the obstetric database at Hvidovre Hospital,
      national registers and questionnaires.

      Trial design Individually randomised trial sited at a large birth clinic in the Copenhagen
      Capital Region, Hvidovre Hospital.

      Trial intervention

      The intervention will have two arms:

        1. A research-based parenting program described in more detail below.

        2. Standard care (control group). The pregnant woman and her partner are offered two
           antenatal lectures on birth and breastfeeding in an auditorium.

      The intervention arm: Groups of approximately 6-7 couples (or mothers) will meet three times
      during pregnancy and 1 time 5 weeks after expected due date, for the duration of 2.5 hours
      per session. (The aim is to create groups of 6-7 couples; however, due to fluctuations in
      uptake groups of 4-9 couples will be deemed acceptable). The sessions will include
      information and discussions about emotions and expectations related to birth and parenting,
      identification of social network resources, couple communication, breastfeeding, parent-child
      attachment, directions on taking care of a newborn, and recognising common signs of mood
      disorders and how to react. A website with parenting information and exercises will be
      created and parents will be encouraged to use this material alongside the sessions. In
      addition to gaining knowledge about issues related to birth and parenting, and creating an
      environment where parents can discuss their feelings and concerns, the program aims at
      enhancing expectant parents' awareness of their own resources and problem-solving strategies.
      Furthermore the way the groups are composited will enable participants to establish relations
      with other expectant parents in their local area. All sessions will be led by a midwife. The
      postnatal session will be conducted in collaboration with a health visitor, to increase
      knowledge on available resources in the local communities Informed consent All participants
      considered for this trial will be provided with written and oral information on this trial so
      that participants can make an informed decision about their participation in this trial. A
      project phone line will be established where participants can contact a project member
      throughout the trial if she has further questions, or wishes to withdraw her consent for
      participation in the trial.

      Data collection Data will be collected from both parents using web-based questionnaires at:
      baseline (approximately 18 weeks gestation) (Tp0), 37 weeks gestation (Tp1), 9 weeks after
      expected due date (Tp2), 6 months after expected due date (Tp3), 1 year after expected due
      date (Tp4). Participants will be contacted via e-mail, when due to answer a questionnaire.
      Two reminders will be sent via additional e-mails, the first after a week and the second
      after 14 days. Data will also be obtained from the hospital obstetric database and the
      national registers.

      Concomitant medication/treatment All participants are free to make use of concomitant
      antenatal/postnatal services and parent groups. As use of other services and parent groups
      may influence the outcomes that we are interested in, use and services will be examined,
      documented and given careful consideration in the analyses.

      Explorative outcomes

      In addition to primary and secondary outcomes, there are following explorative outcomes:

      Post-natal depressive symptomatology and anxiety - questionnaire data, EPDS (tp0,1,2)
      Breastfeeding - questionnaire data (tp0,1,2,3) Use of healthcare services i.e.: for the
      parents obstetric intervention i.e. augmentation of labour, vacuum extraction, caesarean rate
      - data from the hospital obstetric database (tp2), and contact to healthcare professionals
      for depressive symptomatology and unscheduled postnatal visits- questionnaire data (tp2,3).

      Family medicine use - questionnaire data (tp2,3) and register data (tp4) Smoking -
      questionnaire data (tp1,2,3,4) Satisfaction with relationship and family break-ups -
      questionnaire data (tp 0,1,2,3,4), and data from the national registers on divorce and
      break-ups (tp4): mental well-being (tp1,2,3,4)

      In this trial the intermediate outcomes of interest are:

      Parenting resources: trust in own ability to cope with: 1) birth (tp1), 2) discharge (tp1) 3)
      parenting (tp1,2,4) breastfeeding (tp0,1); couple communication (tp0,1,2,3,4); social
      support/network (tp0,1,2,3,4) Statistical plan and data analysis Sample size and power
      estimations We are planning a trial of independent experimental and control participant with
      1 control per experimental participant. 2011 data from the HH Obstetric Database (unpublished
      data) indicate that epidural use among pregnant women is 31%. If the true epidural use for
      experimental participants is 25%, we will need to include 1,175 experimental participants and
      1,175 control participants be able to reject the null hypothesis that the epidural use for
      experimental and control participants are equal with probability (power) 90%. The Type I
      error probability associated with this test of this null hypothesis is 5% Amendment 17th
      February 2014: Due to slow recruitment, we reduce the power from 90% to 80%, thus reducing
      the sample size from 2,350 participants to 1,756 participants.

      Power estimation for the secondary outcome Perceived Stress Scale We are planning a trial
      with 1175 experimental participants and 1175 control participants. In a previous study the
      Perceived Stress Scale response within each participant group was normally distributed with
      standard deviation 6 (18). If the true difference in the experimental and control means is 1,
      we will be able to reject the null hypothesis that the population means of the experimental
      and control groups are equal with probability (power) 98.1%. The type 1 error probability
      associated with this test of this null hypothesis is 0.5.

      Power estimation for the secondary outcome Swedish Parenthood Stress Questionnaire In a
      previous study the Swedish Parenthood Stress Questionnaire response within each subject group
      was normally distributed with standard deviation 0.5 (19). If the true difference in the
      experimental and control means is 0.1, we will be able to reject the null hypothesis that the
      population means of the experimental and control groups are equal with probability (power)
      99.8%. The type 1 error probability associated with this test of this null hypothesis is 0.5.

      Power estimation for the secondary outcome Parenting Alliance Measure In a previous study the
      Parenting Alliance Measure response within each subject group was normally distributed with
      standard deviation 20. If the true difference in the experimental and control means is 4, we
      will be able to reject the null hypothesis that the population means of the experimental and
      control groups are equal with probability (power) 98.7%. The type 1 error probability
      associated with this test of this null hypothesis is 5%.

      Statistical methods Reporting will follow the guidelines of the CONSORT-statement.
      Statistical analyses will be intention to treat as well as per protocol. The level of
      significance will be 0.05.

      The analysis of the primary binary outcome will be done using logistic regression.

      The results of this analysis will be subjected to a worst case and a best case scenario
      analysis of the potential impact of missing values. In the analysis of the two secondary
      outcome measures a mixed model with repeated measures will be used. The fixed effects will
      include a linear and a quadratic time component and their corresponding interactions with the
      intervention indicator. An unstructured covariance matrix will be used initially. If
      convergence cannot be obtained the spatial power law covariance structure will be tried and
      then the compound symmetric model.

      Using the general linear univariate model it will be tested if the mean values differ between
      the two intervention groups at time 1 (9 weeks following birth).

      If the assumptions of the above analyses cannot be fulfilled with reasonable approximation
      the groups will only be compared at time 1 using a nonparametric test (Mann Whitney).

      The unadjusted analyses are the primary analyses. If possible all analyses will be repeated
      adjusted for the protocol specified stratification variable and the baseline value.

      Three explorative subgroup analyses may be conducted in each case provided the subgroup
      interacts significantly with the intervention.

      Dealing with multiplicity, gate keeping will be used to adjust the observed p values for
      primary and secondary outcomes. Both observed and adjusted p values will be reported.

      Direct access to source data/documentation

      The trial will be carried out in accordance with the Declaration of Helsinki in its latest
      form as well as national laws and regulations. The investigators permit audits and inspection
      by providing direct access to source data/documentation. The trial will be monitored by an
      unrelated research group at the National Institute of Public Health. eCRFs will be checked,
      and as minimum the following will be monitored locally:

      All patients for existence (If the CPR number is correct), All patients for documented
      informed consent
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Epidural use
time frame: during labour
description: Epidural use during will be measured using data from the hospital obstetric database
measure: Perceived stress
time frame: baseline, 37 weeks gestation, 9 weeks post-partum, 6 months post-partum, 1 year post-partum
description: The perceived stress scale (PSS) will be used to measure global levels of perceived stress. The PSS takes into account the individual's ability to cope. The scale was developed on the basis of appraisal theory and was designed to tap the degree to which respondents found their lives unpredictable, uncontrollable, and overloading.
measure: Parenting stress
time frame: 9 weeks post-partum, 6 months post-partum, 1 year post-partum
description: Parenting stress will be measured using the Swedish Parenthood Stress Questionnaire (SPSQ) translated into Danish. The scale takes into account the individual's ability to cope and assesses parental stress with a sum score and subscale scores of incompetence, role restriction, social isolation, spouse relationship and health problems
measure: Parenting alliance
time frame: 6 months post-partum, 1 year post-partum
description: Parenting alliance will be measured by the Parenting Alliance Measure
arm group label: Birth and parent preparation
arm group type: Experimental
description: The following subjects will be covered in the sessions:
Session 1 (25 weeks gestation):
Common challenges in the transition to parenthood and in the relationship
Couple communication
Session 2 (33 weeks gestation):
Expectations in relation to birth
The normal course of labour
Obstetric intervention
Pain relief,coping strategies
Partner support
Session 3 (35 weeks gestation):
Feeding a newborn
Interpreting the newborn's signs, symptoms and behaviour
Taking care of a newborn
Mood swings, postnatal depressive symptomatology
Session 4 (5 weeks post-partum):
Birth experiences
Mood swings, postnatal depressive symptomatology
The first time at home with a newborn
Couplehood - partner support, communication, division of household tasks
arm group label: control group
arm group type: No Intervention
description: The control group are offered two lectures in an auditorium during pregnancy - one on breastfeeding and one on labour. This is standard care.
intervention type: Other
intervention name: Birth and parent preparation
description: 4 sessions of birth and parent preparation in small groups of 6-8 couples. 3 sessions during pregnancy, 1 session following birth.
arm group label: Birth and parent preparation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pernille Due, MD
role: Study Director
affiliation: University of Southern Denmark
last name: Vibeke Koushede, PhD
role: Principal Investigator
affiliation: University of Southern Denmark
last name: Christian Gluud, MD
role: Study Chair
affiliation: Copenhagen Trial Unit, Center for Clinical Intervention Research
last name: Morten Grønbæk, MD
role: Study Chair
affiliation: University of Southern Denmark
facility: 
country: Denmark
citation: Barlow J, Parsons J. Group-based parent-training programmes for improving emotional and behavioural adjustment in 0-3 year old children. Cochrane Database Syst Rev. 2003;(1):CD003680. doi: 10.1002/14651858.CD003680.
PMID: 12535483
citation: Abidin RR. The Determinants of Parenting Behavior. Journal of Clinical Child Psychology 1992 Dec;21(4):407-12.
citation: Cowan CP, Cowan PA. When partners become parents: The big life change for couples. Mahwah NJ: Lawrence Erlbaum Associates Publishers; 2000.
citation: Assel MA, Landry SH, Swank PR, Steelman L, Miller-Loncar C, Smith KE. How do mothers' childrearing histories, stress and parenting affect children's behavioural outcomes? Child Care Health Dev. 2002 Sep;28(5):359-68. doi: 10.1046/j.1365-2214.2002.00285.x.
PMID: 12296871
citation: Benzies KM, Harrison MJ, Magill-Evans J. Parenting stress, marital quality, and child behavior problems at age 7 years. Public Health Nurs. 2004 Mar-Apr;21(2):111-21. doi: 10.1111/j.0737-1209.2004.021204.x.
PMID: 14987210
citation: Deater-Deckard K. Parenting stress and child adjustment: Some old hypotheses and new questions. Clinical Psychology-Science and Practice 1998;5(3):314-32
citation: Nystrom K, Ohrling K. Parenthood experiences during the child's first year: literature review. J Adv Nurs. 2004 May;46(3):319-30. doi: 10.1111/j.1365-2648.2004.02991.x.
PMID: 15066113
citation: Schor EL; American Academy of Pediatrics Task Force on the Family. Family pediatrics: report of the Task Force on the Family. Pediatrics. 2003 Jun;111(6 Pt 2):1541-71.
PMID: 12777595
citation: Deater-Deckard K, Pinkerton R, Scarr S. Child care quality and children's behavioral adjustment: a four-year longitudinal study. J Child Psychol Psychiatry. 1996 Nov;37(8):937-48. doi: 10.1111/j.1469-7610.1996.tb01491.x.
PMID: 9119941
citation: National Board of Health D. Status on regional and municipal offers in relation to pregnancy and delivery with focus on delivery and early discharge ( In Danish: Status for regionernes og kommunernes tilbud til gravide og fødende med fokus på ambulante fødsler og tidlige udskrivelser). Copenhagen: National Board of Health, Denmark; 2011. Report No.: j.nr. 7-205-03-31/1/chb.
citation: Gagnon AJ. Individual or group antenatal education for childbirth/parenthood. Cochrane Database Syst Rev. 2000;(4):CD002869. doi: 10.1002/14651858.CD002869.
PMID: 11034780
citation: Dunkley J. Health promotion in midwifery practise: a resource for health professionals. Edinburgh: Bailliere Tindall; 2000.
citation: Biro MA. What has public health got to do with midwifery? Midwives' role in securing better health outcomes for mothers and babies. Women Birth. 2011 Mar;24(1):17-23. doi: 10.1016/j.wombi.2010.06.001. Epub 2010 Jul 2.
PMID: 20598666
citation: Brot C, Poulsen A. Recommendations in relation to antenatal care 2009 (In Danish: Anbefalinger for svangreomsorgen 2009). Copenhagen: National Board of Health, Denmark; 2009.
citation: Haggman-Laitila A, Pietila AM. Perceived benefits on family health of small groups for families with children. Public Health Nurs. 2007 May-Jun;24(3):205-16. doi: 10.1111/j.1525-1446.2007.00627.x.
PMID: 17456122
citation: Barlow J, Coren E. Parent-training programmes for improving maternal psychosocial health. Cochrane Database Syst Rev. 2004;(1):CD002020. doi: 10.1002/14651858.CD002020.pub2.
PMID: 14973981
citation: Sanders MR. Triple P-Positive Parenting Program as a public health approach to strengthening parenting. J Fam Psychol. 2008 Aug;22(4):506-17. doi: 10.1037/0893-3200.22.3.506. Erratum In: J Fam Psychol. 2015 Feb;29(1):38.
PMID: 18729665
citation: Nutbeam D, Kickbusch I. Advancing health literacy: a global challenge for the 21st century. Health Promotion International 2000 Sep;15(3):183-4.
citation: Illeris K, Jarvis P, Kegan R, Engeström Y, Elkjaer B, Mezirow J, et al. Contemporary Theories of Learning: Learning Theorists...in their own words. New York: Routledge; 2009.
citation: Bartholomew L.K, Parcel G.S, Kok G, Gottlieb N.H, Fernández M.E. Planning Health Promotion Programs - An intervention mapping approach. 3 rd ed. San Francisco: Jossey-Bass; 2011.
citation: Whittakar KA, Cowley S. An effective programme is not enough: a review of factors associated with poor attendance and engagement with parenting support programmes. Children and Society 2010.
citation: Milgrom J, Schembri C, Ericksen J, Ross J, Gemmill AW. Towards parenthood: an antenatal intervention to reduce depression, anxiety and parenting difficulties. J Affect Disord. 2011 May;130(3):385-94. doi: 10.1016/j.jad.2010.10.045. Epub 2010 Nov 26.
PMID: 21112641
citation: Ostberg M, Hagekull B, Wettergren S. A measure of parental stress in mothers with small children: dimensionality, stability and validity. Scand J Psychol. 1997 Sep;38(3):199-208. doi: 10.1111/1467-9450.00028.
PMID: 9309950
responsible party type: Sponsor-Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Vibeke Koushede
investigator title: Principal Investigator
mesh term: Depression