xml: <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/NCT06040359</url>
    </required_header>
    <id_info>
      <org_study_id>HR/DP-22/23-39521</org_study_id>
      <nct_id>NCT06040359</nct_id>
    </id_info>
    <brief_title>Pilot Evaluation of the Thriving Mamas Programme</brief_title>
    <official_title>Pilot Evaluation of the Thriving Mamas Programme for Adolescent Perinatal Mental Health</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King's College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Aga Khan University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centro Internacional para Saude Reprodutiva Mocambique</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>UK Research and Innovation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>King's College London</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this pilot study is to evaluate the feasibility, appropriateness, and&#xD;
        acceptability of a mental health prevention intervention among adolescents during pregnancy&#xD;
        and the year after birth (perinatal period) in Kenya and Mozambique. The main questions it&#xD;
        aims to answer are:&#xD;
  &#xD;
          -  Is the intervention feasible, acceptable, appropriate, and delivered/received with high&#xD;
             fidelity, to adolescent girls, their friends/family members and service providers?&#xD;
  &#xD;
          -  Are the implementation strategies acceptable, appropriate, feasible to all relevant&#xD;
             stakeholders?&#xD;
  &#xD;
          -  What impact does the intervention have on adolescent mothers' mental health?&#xD;
  &#xD;
          -  What impact does the intervention have on adolescent mothers' social, economic, and&#xD;
             education outcomes?&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  Participate in nine individual and group sessions focused on improving mental and&#xD;
             perinatal health literacy and increasing life skills&#xD;
  &#xD;
          -  Receive standard perinatal care&#xD;
  &#xD;
        Researchers will compare findings with girls receiving standard perinatal care only to see if&#xD;
        the intervention has an impact on adolescents' mental health, social, economic and education&#xD;
        outcomes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">May 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Intervention Feasibility</measure>
      <time_frame>10-12 weeks post-partum</time_frame>
      <description>Feasibility of Intervention Measure (FIM); Subjective report of feasibility of intervention; measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Minimum=5, Maximum=25; higher score is better</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention Acceptability</measure>
      <time_frame>10-12 weeks post-partum</time_frame>
      <description>Acceptability of Intervention Measure (AIM); Subjective report of acceptability of intervention; A 5-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Minimum=5, Maximum=25; higher score is better</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention Appropriateness</measure>
      <time_frame>10-12 weeks post-partum</time_frame>
      <description>Intervention Appropriateness Measure (IAM); Subjective report of appropriateness of intervention; A 5-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Minimum=5, Maximum=25; higher score is better</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention Fidelity</measure>
      <time_frame>Through intervention delivery, an average of 24 weeks</time_frame>
      <description>Enhancing Assessment of Common Therapeutic Factors (ENACT); subjective report of provider fidelity and perception of care; Minimum=0; Maximum=13; higher score is better</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Training Feasibility</measure>
      <time_frame>Immediately after provider training</time_frame>
      <description>Feasibility of Intervention Measure (FIM); Subjective report of feasibility of intervention; measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Minimum=5, Maximum=25; higher score is better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Training Acceptability</measure>
      <time_frame>Immediately after provider training</time_frame>
      <description>Acceptability of Intervention Measure (AIM); Subjective report of acceptability of intervention; A 5-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Minimum=5, Maximum=25; higher score is better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Training Appropriateness</measure>
      <time_frame>Immediately after provider training</time_frame>
      <description>Intervention Appropriateness Measure (IAM); Subjective report of appropriateness of intervention; A 5-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Minimum=5, Maximum=25; higher score is better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Knowledge</measure>
      <time_frame>Baseline and immediately after provider training</time_frame>
      <description>Study-specific measure of mentor mothers' knowledge of issues regarding pregnancy, childbirth, caregiving, mental health, and referral pathways will be assessed using a study-specific quiz based upon the intervention manual; Minimum=0, Maximum=16; higher score is better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in mental health attitudes</measure>
      <time_frame>Baseline and immediately after provider training</time_frame>
      <description>Social Distance Scale (SDS); The SDS measures the acceptability of different degrees of social distance and, by inference, the attitude of the respondent to the person with the condition; Minimum=1, Maximum=96; higher score is better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in adolescent pregnancy attitudes</measure>
      <time_frame>Baseline and immediately after provider training</time_frame>
      <description>Study-specific attitudes towards adolescent pregnancy survey; Minimum=4, Maximum=20; lower score is better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Provider competency</measure>
      <time_frame>Immediately after provider training</time_frame>
      <description>Study-specific single 10-point scale to assess provider ability to deliver the intervention; Minimum=0, Maximum=10; higher score is better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recruitment rate</measure>
      <time_frame>pre-intervention</time_frame>
      <description>Proportion of adolescents providing consent to participate in the study</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost of intervention</measure>
      <time_frame>through study completion, an average of 24 weeks</time_frame>
      <description>Total and average cost of the intervention per participant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in adolescent depression</measure>
      <time_frame>through study completion, an average of 24 weeks</time_frame>
      <description>Patient Health Questionnaire (PHQ-9); Nine-item screening tool which assesses depression symptoms according to clinical criteria. Minimum=0, Maximum=27. A score ≥10 indicates moderate to severe depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in adolescent anxiety</measure>
      <time_frame>through study completion, an average of 24 weeks</time_frame>
      <description>Generalised Anxiety Disorder scale (GAD-7); Seven-item screening tool which assesses anxiety symptoms according to clinical criteria. Minimum=0, Maximum=21. A score ≥10 indicates moderate to severe anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in adolescent quality of life</measure>
      <time_frame>through study completion, an average of 24 weeks</time_frame>
      <description>WHO Quality of Life brief version (WHOQOL-BREF); 26-item scale assesses a respondent's perceived quality of life across four domains: physical health; psychological; social relationships; and environment. Total minimum=25, Total maximum=125. Higher scores indicate greater quality of life in a particular domain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in adolescent social support</measure>
      <time_frame>through study completion, an average of 24 weeks</time_frame>
      <description>Multidimensional Scale of Perceived Social Support (MSPSS); The MSPSS is a 12-item scale which measures social support from family, friends and significant others. Minimum=12, Maximum=84. Higher scores indicate greater social support.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adolescent parenting competency</measure>
      <time_frame>through study completion, an average of 24 weeks</time_frame>
      <description>Parenting Sense of Competency Scale; 17-item scale to measure adolescents' perceived parenting abilities. Minimum=17, Maximum=102. Higher scores indicate greater perceived competence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perinatal appointment attendance</measure>
      <time_frame>through study completion, an average of 24 weeks</time_frame>
      <description>Number of participants attending antenatal appointments</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Referral uptake</measure>
      <time_frame>10-12 weeks post-partum</time_frame>
      <description>Proportion of adolescents attending referral appointments</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in infant vaccination</measure>
      <time_frame>Baseline and 10-12 weeks post-partum</time_frame>
      <description>Number of participants intending to or having had their babies vaccinated</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in breastfeeding</measure>
      <time_frame>Baseline and 10-12 weeks post-partum</time_frame>
      <description>Number of participants intendng to or are currently breastfeeding</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in intended time to next pregnancy</measure>
      <time_frame>Baseline and 10-12 weeks post-partum</time_frame>
      <description>Study-specific health behaviours questionnaire to assess intended or actual contraceptive Nuimber of participants that want more children who intend to wait at least 15 months before next pregnancy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in contraceptive use</measure>
      <time_frame>Baseline and 10-12 weeks post-partum</time_frame>
      <description>Number of participants intending to or currently using contraceptives to delay pregnancy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in perception of intervention</measure>
      <time_frame>Baseline and 10-12 weeks post-partum</time_frame>
      <description>Study-specific five-item measure assessing knowledge gained, interest in intervention, and support recieved; Minimum=0; Maximum=5; higher score is better</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">156</enrollment>
    <condition>Perinatal Mental Health</condition>
    <arm_group>
      <arm_group_label>Thriving Mama programme</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Nine meetings delivered in either group (5 meetings), individual (1 meeting), or family group (2 meetings) formats over 10 weeks with an additional individual meeting 10-12 weeks postpartum by a trained mother in the community. Each meeting focuses on the girl's physical and mental health, taking care of a newborn, life skills, future-planning and social support and community-based services. Meetings will take place in a mixture of private settings in health facilities, community facilities, and participant homes. Adolescents will also receive usual perinatal care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual perinatal care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Each visit includes care that is appropriate to the overall condition and stage of pregnancy and should include four main categories of care:&#xD;
  Identification of pre-existing health conditions (e.g., check for weight and nutrition status, anemia, hypertension, syphilis, HIV status);&#xD;
  Early detection of complications arising during pregnancy (e.g., check for pre-eclampsia, gestational diabetes);&#xD;
  Health promotion and disease prevention (e.g., tetanus vaccine, prevention and treatment of malaria, nutrition counseling, micronutrient supplements, family planning counseling); and&#xD;
  Birth preparedness and complication planning (e.g., birth and emergency plan, breastfeeding counseling, antiretrovirals for HIV positive women and reducing mother-to- child transmission of HIV)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>The Thriving Mamas programme</intervention_name>
      <description>Enhanced antenatal course plus usual perinatal care</description>
      <arm_group_label>Thriving Mama programme</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Usual care</intervention_name>
      <description>Usual perinatal care</description>
      <arm_group_label>Usual perinatal care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Mentor mothers: (A) aged 20 years or older; (B) female; (C) experience of pregnancy&#xD;
               and/or parenting; and (D) live within the study site&#xD;
  &#xD;
            -  Adolescent girls: (A) up to 28 weeks pregnant; and (B) aged 15-19 years&#xD;
  &#xD;
            -  Friends/family members: (A) identified by an adolescent or young woman participating&#xD;
               in the study; (B) participation agreed by other participating girls; and (C) aged 18&#xD;
               years or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Mentor mothers will be excluded from participating if they are unable to attend&#xD;
               training or deliver the intervention sessions&#xD;
  &#xD;
            -  Adolescent girls will be excluded from the study if they are unable to provide&#xD;
               informed consent or are unable to participate in the intervention, due to existing&#xD;
               health conditions&#xD;
  &#xD;
            -  Friends/family members will not be excluded so long as they meet inclusion criteria&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Tatiana Salisbury</last_name>
      <phone>+44(0)20 7848 85107</phone>
      <email>tatiana.salisbury@kcl.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Aga Khan University</name>
        <address>
          <city>Nairobi</city>
          <country>Kenya</country>
        </address>
      </facility>
      <contact>
        <last_name>Marleen Temmerman</last_name>
        <email>marleen.temmerman@aku.edu</email>
      </contact>
      <contact_backup>
        <last_name>Margrette Hanselmann</last_name>
        <email>margrette.hanselmann@aku.edu</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Centro Internacional para Saude Reprodutiva Mocambique</name>
        <address>
          <city>Maputo</city>
          <country>Mozambique</country>
        </address>
      </facility>
      <contact>
        <last_name>Malica de Melo</last_name>
        <email>m.demelo@icrhm.org.mz</email>
      </contact>
      <contact_backup>
        <last_name>Fernando Chissale</last_name>
        <email>f.chissale@icrhm.org.mz</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Kenya</country>
      <country>Mozambique</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Adolescent mental health</keyword>
    <keyword>Maternal mental health</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040359
  org study id: HR/DP-22/23-39521
  nct id: NCT06040359
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this pilot study is to evaluate the feasibility, appropriateness, and
        acceptability of a mental health prevention intervention among adolescents during pregnancy
        and the year after birth (perinatal period) in Kenya and Mozambique. The main questions it
        aims to answer are:
  
          -  Is the intervention feasible, acceptable, appropriate, and delivered/received with high
             fidelity, to adolescent girls, their friends/family members and service providers?
  
          -  Are the implementation strategies acceptable, appropriate, feasible to all relevant
             stakeholders?
  
          -  What impact does the intervention have on adolescent mothers' mental health?
  
          -  What impact does the intervention have on adolescent mothers' social, economic, and
             education outcomes?
  
        Participants will:
  
          -  Participate in nine individual and group sessions focused on improving mental and
             perinatal health literacy and increasing life skills
  
          -  Receive standard perinatal care
  
        Researchers will compare findings with girls receiving standard perinatal care only to see if
        the intervention has an impact on adolescents' mental health, social, economic and education
        outcomes.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Intervention Feasibility
  time frame: 10-12 weeks post-partum
  description: Feasibility of Intervention Measure (FIM); Subjective report of feasibility of intervention; measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Minimum=5, Maximum=25; higher score is better
  measure: Intervention Acceptability
  time frame: 10-12 weeks post-partum
  description: Acceptability of Intervention Measure (AIM); Subjective report of acceptability of intervention; A 5-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Minimum=5, Maximum=25; higher score is better
  measure: Intervention Appropriateness
  time frame: 10-12 weeks post-partum
  description: Intervention Appropriateness Measure (IAM); Subjective report of appropriateness of intervention; A 5-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Minimum=5, Maximum=25; higher score is better
  measure: Intervention Fidelity
  time frame: Through intervention delivery, an average of 24 weeks
  description: Enhancing Assessment of Common Therapeutic Factors (ENACT); subjective report of provider fidelity and perception of care; Minimum=0; Maximum=13; higher score is better
  measure: Training Feasibility
  time frame: Immediately after provider training
  description: Feasibility of Intervention Measure (FIM); Subjective report of feasibility of intervention; measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Minimum=5, Maximum=25; higher score is better
  measure: Training Acceptability
  time frame: Immediately after provider training
  description: Acceptability of Intervention Measure (AIM); Subjective report of acceptability of intervention; A 5-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Minimum=5, Maximum=25; higher score is better
  measure: Training Appropriateness
  time frame: Immediately after provider training
  description: Intervention Appropriateness Measure (IAM); Subjective report of appropriateness of intervention; A 5-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Minimum=5, Maximum=25; higher score is better
  measure: Knowledge
  time frame: Baseline and immediately after provider training
  description: Study-specific measure of mentor mothers' knowledge of issues regarding pregnancy, childbirth, caregiving, mental health, and referral pathways will be assessed using a study-specific quiz based upon the intervention manual; Minimum=0, Maximum=16; higher score is better
  measure: Change in mental health attitudes
  time frame: Baseline and immediately after provider training
  description: Social Distance Scale (SDS); The SDS measures the acceptability of different degrees of social distance and, by inference, the attitude of the respondent to the person with the condition; Minimum=1, Maximum=96; higher score is better
  measure: Change in adolescent pregnancy attitudes
  time frame: Baseline and immediately after provider training
  description: Study-specific attitudes towards adolescent pregnancy survey; Minimum=4, Maximum=20; lower score is better
  measure: Provider competency
  time frame: Immediately after provider training
  description: Study-specific single 10-point scale to assess provider ability to deliver the intervention; Minimum=0, Maximum=10; higher score is better
  measure: Recruitment rate
  time frame: pre-intervention
  description: Proportion of adolescents providing consent to participate in the study
  measure: Cost of intervention
  time frame: through study completion, an average of 24 weeks
  description: Total and average cost of the intervention per participant
  measure: Change in adolescent depression
  time frame: through study completion, an average of 24 weeks
  description: Patient Health Questionnaire (PHQ-9); Nine-item screening tool which assesses depression symptoms according to clinical criteria. Minimum=0, Maximum=27. A score ≥10 indicates moderate to severe depression.
  measure: Change in adolescent anxiety
  time frame: through study completion, an average of 24 weeks
  description: Generalised Anxiety Disorder scale (GAD-7); Seven-item screening tool which assesses anxiety symptoms according to clinical criteria. Minimum=0, Maximum=21. A score ≥10 indicates moderate to severe anxiety.
  measure: Change in adolescent quality of life
  time frame: through study completion, an average of 24 weeks
  description: WHO Quality of Life brief version (WHOQOL-BREF); 26-item scale assesses a respondent's perceived quality of life across four domains: physical health; psychological; social relationships; and environment. Total minimum=25, Total maximum=125. Higher scores indicate greater quality of life in a particular domain.
  measure: Change in adolescent social support
  time frame: through study completion, an average of 24 weeks
  description: Multidimensional Scale of Perceived Social Support (MSPSS); The MSPSS is a 12-item scale which measures social support from family, friends and significant others. Minimum=12, Maximum=84. Higher scores indicate greater social support.
  measure: Adolescent parenting competency
  time frame: through study completion, an average of 24 weeks
  description: Parenting Sense of Competency Scale; 17-item scale to measure adolescents' perceived parenting abilities. Minimum=17, Maximum=102. Higher scores indicate greater perceived competence.
  measure: Perinatal appointment attendance
  time frame: through study completion, an average of 24 weeks
  description: Number of participants attending antenatal appointments
  measure: Referral uptake
  time frame: 10-12 weeks post-partum
  description: Proportion of adolescents attending referral appointments
  measure: Change in infant vaccination
  time frame: Baseline and 10-12 weeks post-partum
  description: Number of participants intending to or having had their babies vaccinated
  measure: Change in breastfeeding
  time frame: Baseline and 10-12 weeks post-partum
  description: Number of participants intendng to or are currently breastfeeding
  measure: Change in intended time to next pregnancy
  time frame: Baseline and 10-12 weeks post-partum
  description: Study-specific health behaviours questionnaire to assess intended or actual contraceptive Nuimber of participants that want more children who intend to wait at least 15 months before next pregnancy
  measure: Change in contraceptive use
  time frame: Baseline and 10-12 weeks post-partum
  description: Number of participants intending to or currently using contraceptives to delay pregnancy
  measure: Change in perception of intervention
  time frame: Baseline and 10-12 weeks post-partum
  description: Study-specific five-item measure assessing knowledge gained, interest in intervention, and support recieved; Minimum=0; Maximum=5; higher score is better
  arm group label: Thriving Mama programme
  arm group type: Experimental
  description: Nine meetings delivered in either group (5 meetings), individual (1 meeting), or family group (2 meetings) formats over 10 weeks with an additional individual meeting 10-12 weeks postpartum by a trained mother in the community. Each meeting focuses on the girl's physical and mental health, taking care of a newborn, life skills, future-planning and social support and community-based services. Meetings will take place in a mixture of private settings in health facilities, community facilities, and participant homes. Adolescents will also receive usual perinatal care.
  arm group label: Usual perinatal care
  arm group type: Active Comparator
  description: Each visit includes care that is appropriate to the overall condition and stage of pregnancy and should include four main categories of care:
  Identification of pre-existing health conditions (e.g., check for weight and nutrition status, anemia, hypertension, syphilis, HIV status);
  Early detection of complications arising during pregnancy (e.g., check for pre-eclampsia, gestational diabetes);
  Health promotion and disease prevention (e.g., tetanus vaccine, prevention and treatment of malaria, nutrition counseling, micronutrient supplements, family planning counseling); and
  Birth preparedness and complication planning (e.g., birth and emergency plan, breastfeeding counseling, antiretrovirals for HIV positive women and reducing mother-to- child transmission of HIV)
  intervention type: Other
  intervention name: The Thriving Mamas programme
  description: Enhanced antenatal course plus usual perinatal care
  arm group label: Thriving Mama programme
  intervention type: Other
  intervention name: Usual care
  description: Usual perinatal care
  arm group label: Usual perinatal care
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tatiana Salisbury
  phone: +44(0)20 7848 85107
  email: tatiana.salisbury@kcl.ac.uk
  facility: 
  contact: 
  contact backup: 
  facility: 
  contact: 
  contact backup: 
  country: Kenya
  country: Mozambique
  responsible party type: Sponsor
  sharing ipd: Yes