<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/NCT04440657</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01349</org_study_id>
    <nct_id>NCT04440657</nct_id>
  </id_info>
  <brief_title>Self-assured Parents - a Parenting Support Program for Immigrant Parents With Teenage Children Living in Deprived Areas</brief_title>
  <acronym>SAP</acronym>
  <official_title>Self-assured Parents - a Parenting Support Program for Immigrant Parents With Teenage Children Living in Deprived Areas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University West, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swedish Council for Working Life and Social Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University West, Sweden</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>
      Parents have the primary responsibility for child socialization and development, but not all&#xD;
      parents have the same possibilities to promote their children's positive development.&#xD;
      Immigrant parents living in deprived areas often worry about their children's safety and&#xD;
      future, at the same time as they have difficulties facilitating the best development&#xD;
      potential for their children. Social services can help parents and their children to attain&#xD;
      more promising developmental outcomes through focus on early preventive parenting support&#xD;
      efforts, but these efforts need to be culturally tailored for the best possible results. For&#xD;
      this reason, social services in the municipality of Örebro developed a culturally sensitive&#xD;
      parenting support program aimed at immigrant parents living in deprived areas, who are&#xD;
      worried that their children (age 12-18) engage in or will be exposed to harmful environments.&#xD;
&#xD;
      The Self-Assured Parenting Program (SAP) offers support to these parents by building on&#xD;
      protective factors and strengthening parents in their parenting through focus on parenting&#xD;
      competence and parent-child communication.&#xD;
&#xD;
      The purpose of SAP is to increase parents' self-confidence and communication between parents&#xD;
      and their teenagers as well as to reduce parents' worries through activities that have a&#xD;
      clear focus on empowerment and knowledge of child development. This multi-design project aims&#xD;
      to test the implementation and effect of TF in Örebro and other Swedish municipalities with&#xD;
      similar problems through observation, interviews with parents and groupleaders/managers as&#xD;
      well as longitudinal effect measurements of parenting competence, parent-child communication&#xD;
      and worries about their children's psychosocial development. This project will allow a&#xD;
      partnership between social workers and researchers to be formed in order to generate&#xD;
      practice-based evidence about implementation of support to deprived parents, which can be&#xD;
      used in the context of everyday social service practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 17, 2021</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 20, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Parent-child communication</measure>
    <time_frame>6 months</time_frame>
    <description>Parent-child communication (Kerr &amp; Stattin, 2000) will be assessed at 7 time points using an instrument with 22 questions measuring 1) Parent knowledge of child whereabouts (6 items) (e.g. &quot;Do you know what places the child visits when he/she is out with his friends in the evenings?&quot;) 2) Parent control (5 items) (e.g. &quot;Does the child need permission to stay out late on a weekday evening?&quot;) 3) Parent solicitation (6 questions) (e.g. &quot;Do you ask the child to tell you about things that happen in his/her spare time?&quot;) and C hild Disclosure (5 items) (e.g. &quot;When the child has been out one evening, does he/she want to tell you about what she/he has done?&quot;). A 5-point Likert scale (1 - almost never to 5 - very often) will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Parents' worries</measure>
    <time_frame>6 months</time_frame>
    <description>Parents' worries (Van Zalk et al., 2018) about their children will be assessed at 7 time points on a scale comprising six questions (e.g. &quot;Are you worried that your child will get caught by the police?&quot;) answered on a 5-point Likert scale (1 - yes, always to 5 - no, never).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Parental Self-efficacy</measure>
    <time_frame>6 months</time_frame>
    <description>Parental self-efficacy will be assessed at 7 time points by the Parenting Sense of Competence in Parenting Scale (PSOC , Gilmore&#xD;
&amp; C uskelly, 2009; Osman, 2017). The scale has subscales measuring satisfaction in parenting (9 items) (e.g.&#xD;
&quot;Although parenting can be rewarding, I am frustrated now that the child is the age he/she is&quot;) and parental selfefficacy (7 items) (e.g. &quot; I think I have what it takes to be a good parent to my child&quot;). Answers are provided on 6-point Likert scales (1 - fully agree to 6 - completely disagree).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Parenting</condition>
  <condition>Parent-Child Relations</condition>
  <condition>Adolescent Behavior</condition>
  <arm_group>
    <arm_group_label>Immigrant parents</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All enrolled parents will be included in the parenting program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-Assured Parenting program</intervention_name>
    <description>Parents will receive parenting education for 10 weeks</description>
    <arm_group_label>Immigrant parents</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  parents of adolescent Children&#xD;
&#xD;
          -  immigrant background&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  parents of younger Children&#xD;
&#xD;
          -  Swedish background&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University West</name>
      <address>
        <city>Trollhättan</city>
        <state>Västra Götaland</state>
        <zip>46132</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sabina Kapetanovic, Ph.D.</last_name>
      <phone>+46520223717</phone>
      <email>sabina.kapetanovic@hv.se</email>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT04440657
org study id: 2020-01349
nct id: NCT04440657
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Parents have the primary responsibility for child socialization and development, but not all
      parents have the same possibilities to promote their children's positive development.
      Immigrant parents living in deprived areas often worry about their children's safety and
      future, at the same time as they have difficulties facilitating the best development
      potential for their children. Social services can help parents and their children to attain
      more promising developmental outcomes through focus on early preventive parenting support
      efforts, but these efforts need to be culturally tailored for the best possible results. For
      this reason, social services in the municipality of Örebro developed a culturally sensitive
      parenting support program aimed at immigrant parents living in deprived areas, who are
      worried that their children (age 12-18) engage in or will be exposed to harmful environments.

      The Self-Assured Parenting Program (SAP) offers support to these parents by building on
      protective factors and strengthening parents in their parenting through focus on parenting
      competence and parent-child communication.

      The purpose of SAP is to increase parents' self-confidence and communication between parents
      and their teenagers as well as to reduce parents' worries through activities that have a
      clear focus on empowerment and knowledge of child development. This multi-design project aims
      to test the implementation and effect of TF in Örebro and other Swedish municipalities with
      similar problems through observation, interviews with parents and groupleaders/managers as
      well as longitudinal effect measurements of parenting competence, parent-child communication
      and worries about their children's psychosocial development. This project will allow a
      partnership between social workers and researchers to be formed in order to generate
      practice-based evidence about implementation of support to deprived parents, which can be
      used in the context of everyday social service practice.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Parent-child communication
time frame: 6 months
description: Parent-child communication (Kerr & Stattin, 2000) will be assessed at 7 time points using an instrument with 22 questions measuring 1) Parent knowledge of child whereabouts (6 items) (e.g. "Do you know what places the child visits when he/she is out with his friends in the evenings?") 2) Parent control (5 items) (e.g. "Does the child need permission to stay out late on a weekday evening?") 3) Parent solicitation (6 questions) (e.g. "Do you ask the child to tell you about things that happen in his/her spare time?") and C hild Disclosure (5 items) (e.g. "When the child has been out one evening, does he/she want to tell you about what she/he has done?"). A 5-point Likert scale (1 - almost never to 5 - very often) will be used.
measure: Change in Parents' worries
time frame: 6 months
description: Parents' worries (Van Zalk et al., 2018) about their children will be assessed at 7 time points on a scale comprising six questions (e.g. "Are you worried that your child will get caught by the police?") answered on a 5-point Likert scale (1 - yes, always to 5 - no, never).
measure: Change in Parental Self-efficacy
time frame: 6 months
description: Parental self-efficacy will be assessed at 7 time points by the Parenting Sense of Competence in Parenting Scale (PSOC , Gilmore
& C uskelly, 2009; Osman, 2017). The scale has subscales measuring satisfaction in parenting (9 items) (e.g.
"Although parenting can be rewarding, I am frustrated now that the child is the age he/she is") and parental selfefficacy (7 items) (e.g. " I think I have what it takes to be a good parent to my child"). Answers are provided on 6-point Likert scales (1 - fully agree to 6 - completely disagree).
arm group label: Immigrant parents
arm group type: Experimental
description: All enrolled parents will be included in the parenting program
intervention type: Behavioral
intervention name: Self-Assured Parenting program
description: Parents will receive parenting education for 10 weeks
arm group label: Immigrant parents
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Sweden
responsible party type: Sponsor
sharing ipd: No