<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/NCT04443504</url>
  </required_header>
  <id_info>
    <org_study_id>1920-217</org_study_id>
    <nct_id>NCT04443504</nct_id>
  </id_info>
  <brief_title>An Online Post-Adoption Family Intervention Using Trust-Based Relational Intervention (TBRI) to Improve Understanding, Well-Being, and Connection in Adoptive Families</brief_title>
  <official_title>A Pilot Study on the Effectiveness of an Online Intervention for Adoptive Families</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jana Hunsley</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Christian University</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 current study aims to examine the effectiveness of an online, self-paced post-adoption&#xD;
      intervention to improve understanding, well-being, and connection within adoptive families.To&#xD;
      evaluate the effectiveness of this intervention, a mixed method, pre-post design with two&#xD;
      conditions will be used. Data from standard, reliable measures and free-response items will&#xD;
      be collected pre- and post-intervention from participants in two conditions: the intervention&#xD;
      condition and the waitlist condition. The intervention condition involves receiving the&#xD;
      intervention immediately following pre-assessments; the waitlist condition involves receiving&#xD;
      the intervention approximately 3 months after the intervention condition once all data&#xD;
      collection is completed.&#xD;
&#xD;
      The study aims to answer six research questions. Each research question involves analyses of&#xD;
      the differences between the intervention and waitlist conditions across multiple time points.&#xD;
&#xD;
        1. What is the intervention's effect on improving awareness of the needs of different&#xD;
           family members and understanding how to meet these needs? Hypothesis 1: At&#xD;
           post-intervention, parents in the intervention condition will report an improved&#xD;
           awareness of the needs of each family member and greater understanding of how to meet&#xD;
           these needs.&#xD;
&#xD;
        2. What is the intervention's effect on parent well-being (i.e., parenting confidence and&#xD;
           parenting stress) from pre- to post-intervention? Hypothesis 2: Parents in the&#xD;
           intervention condition will report increased parenting confidence and trending decreases&#xD;
           in parenting stress from pre- to post-intervention compared to those in the waitlist&#xD;
           condition.&#xD;
&#xD;
        3. What is the intervention's effect on child well-being (i.e., self-esteem and emotional&#xD;
           and behavioral problems) from pre- to post-intervention? Hypothesis 3: Children in the&#xD;
           intervention condition will report increased self-esteem and trending decreases in&#xD;
           emotional and behavioral problems from pre- to post-intervention compared to those in&#xD;
           the waitlist condition.&#xD;
&#xD;
        4. What is the intervention's effect on the quality of the parent-child relationship from&#xD;
           pre- to post-intervention? Hypothesis 4: Both parents and children in the intervention&#xD;
           condition will report improved connection in the parent-child relationship from pre- to&#xD;
           post-intervention compared to those in the waitlist condition.&#xD;
&#xD;
        5. As an exploratory question, what is the intervention's effect on the quality of the&#xD;
           sibling relationship from pre- to post-intervention? Hypothesis 5: Children in the&#xD;
           intervention condition will report an improvement in the quality of their relationship&#xD;
           with their sibling(s) from pre- to post-intervention compared to children in the&#xD;
           waitlist condition.&#xD;
&#xD;
        6. What is the intervention's effect on connection and communication within the overall&#xD;
           family system from pre- to post-intervention? Hypothesis 6: Parents and children in the&#xD;
           intervention condition will report increased family communication and family connection&#xD;
           in the whole family system from pre- to post-intervention compared to parents and&#xD;
           children in the waitlist condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One member of the family will complete a survey to ensure eligibility criteria have been met.&#xD;
      In the recruitment application, the individual who completes the application will include an&#xD;
      email address to be used as the primary contact person for the family. If the family meets&#xD;
      the eligibility criteria, the primary contact person will receive consent forms to complete&#xD;
      for each member of the family. Once consent forms are completed for the entire family and&#xD;
      each member has agreed to participate in research, the primary contact will complete a&#xD;
      demographic survey of basic household information. In the demographic survey, the primary&#xD;
      contact will include email addresses for each family member 18 years and older. See timeline&#xD;
      below for reference. *Note: dates are approximate.&#xD;
&#xD;
      Once consented, online surveys of pre-assessments will be sent to families via email (via&#xD;
      individual links; survey links for children under 18 will be sent to the primary contact).&#xD;
      Pre-assessments include individual, dyad, and family measures to examine the effectiveness of&#xD;
      the intervention in multiple systems of the family. Each family member who is 12 years and&#xD;
      older will complete pre-assessments during a one-week data collection period.&#xD;
&#xD;
      After pre-assessments are complete, families will be randomly assigned to the intervention or&#xD;
      waitlist condition using a random number generator, and families will be notified of their&#xD;
      assigned condition.&#xD;
&#xD;
      Both the waitlist and intervention condition will complete pre-assessments.&#xD;
&#xD;
      Once the pre-assessment data collection period is complete, families in the intervention&#xD;
      condition will have one week before the intervention begins. The primary contact of families&#xD;
      assigned to the intervention condition will receive an email with instructions to register&#xD;
      and to prepare for the 4-week intervention series. The waitlist condition will do nothing&#xD;
      during this time.&#xD;
&#xD;
      One week after pre-assessment data collection is complete, the 4-week intervention series&#xD;
      will begin. The intervention includes 4 weekly sessions. Each weekly session involves parents&#xD;
      watching a 15-minute mini-webinar, children watching a 5-minute video, parents and children&#xD;
      12 years and older completing separate reflection questions (*note these questions will be&#xD;
      used as data for analysis), and families completing two family activities together (an&#xD;
      activity aimed at improving connection and an activity aimed at improving communication). The&#xD;
      primary contact will complete a checklist of which activities were completed that week. The&#xD;
      intervention should take approximately 1.5-3 hours each week for the whole family for a total&#xD;
      of 6-12 hours over the 4-week period.&#xD;
&#xD;
      The intervention condition will complete the first week's activities at their own pace within&#xD;
      the seven days. On each subsequent Monday of the four weeks, the next week's activities will&#xD;
      open for the intervention condition to access. The previous weeks' activities will still be&#xD;
      available to the families during the duration of the intervention. All intervention&#xD;
      activities will be completed within the four-week time period.&#xD;
&#xD;
      Two weeks after the intervention condition completes the intervention series,&#xD;
      post-assessments will be sent to both the intervention and waitlist conditions.&#xD;
      Post-assessments will be the same as the pre-assessments in order to examine differences&#xD;
      between pre- and post-intervention. Families will have a one-week period to complete the&#xD;
      post-assessments.&#xD;
&#xD;
      Three months after the intervention condition completed the intervention, 3-month follow-up&#xD;
      assessments will be sent to both the intervention and waitlist conditions. 3-month follow-up&#xD;
      assessments will be the same as the pre- and post-assessments. This follow-up data collection&#xD;
      period is to determine any longer-term changes that may occur in the family systems&#xD;
      post-intervention that may not occur closely following the intervention at the&#xD;
      post-intervention data collection time point. Families will have a one-week period to&#xD;
      complete the 3-month follow-up assessments.&#xD;
&#xD;
      One week after the three-month follow-up data collection period is completed, families&#xD;
      randomly assigned to the waitlist condition will receive the invitation to register for the&#xD;
      intervention. The waitlist condition will receive instructions to register for the&#xD;
      intervention and to prepare for the 4-week intervention series. The waitlist condition will&#xD;
      receive the intervention series in the same order and manner as the intervention condition.&#xD;
&#xD;
      Approximately 6 months after the intervention condition completed the intervention, the&#xD;
      intervention condition will complete 6-month follow-up assessments. This follow-up data&#xD;
      collection is to determine the long-term changes that may occur in the family system&#xD;
      post-intervention. Only the intervention condition will complete this data collection period&#xD;
      as the waitlist condition would have completed the intervention at this time.&#xD;
&#xD;
      In total, participation in this study will take approximately 15-20 hours during a 6-month&#xD;
      period with approximately 4 hours total to complete surveys and assessments and 6-15 hours to&#xD;
      participate in the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">April 5, 2021</completion_date>
  <primary_completion_date type="Actual">April 5, 2021</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>
    <intervention_model_description>Two groups will be created using random assignment: an intervention group and a waitlist control group who will receive the intervention 3 months after the intervention group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Family Cohesion</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Family Adaptability and Cohesion Scale IV</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Parent and Child Relationship</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Inventory of Parent and Peer Attachment-Revised, Child-Parent Relationship Scale-Short Form</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Parenting Stress</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Parental Stress Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Parenting Competence</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Parenting Sense of Competence Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Child Self-Esteem</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Rosenberg Self-Esteem Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Child Emotional and Behavioral Problems</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Strengths &amp; Difficulties Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sibling Relationship</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Sibling Relationship Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Family Relations</condition>
  <condition>Parenting</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The waitlist group will receive the intervention 3 months after the intervention group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Connected Family Series</intervention_name>
    <description>The intervention is an online, self-paced post-adoption family intervention that occurs over a 4-week period to support adoptive families post-adoption.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Study participants must be families who have legally adopted or have legal permanency&#xD;
             of all children in their family.&#xD;
&#xD;
          -  Study participants must have at least one adopted child in the family.&#xD;
&#xD;
          -  Adoptive families who have at least two children with at least one child being 12&#xD;
             years or older. It does not matter if the child who is 12 years or older is an adopted&#xD;
             or biological child in the family.&#xD;
&#xD;
          -  All members of the family must be willing to participate in the intervention and all&#xD;
             members 12 years and older must be willing to participate in the research assessments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Families who are current foster homes.&#xD;
&#xD;
          -  Families who have at least one member of the family who has recently been hospitalized&#xD;
             for psychiatric issues.&#xD;
&#xD;
          -  Families in which at least one member of the family is at risk of harm to self or&#xD;
             others.&#xD;
&#xD;
          -  Two-parent households in which the marriage is a consistent source of conflict.&#xD;
&#xD;
          -  Families who have participated in Hope Connection 2.0, a therapeutic family camp.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Texas Christian University</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>October 11, 2021</last_update_submitted>
  <last_update_submitted_qc>October 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Texas Christian University</investigator_affiliation>
    <investigator_full_name>Jana Hunsley</investigator_full_name>
    <investigator_title>Graduate Research Assistant</investigator_title>
  </responsible_party>
  <keyword>post-adoption intervention</keyword>
  <keyword>Trust-Based Relational Intervention</keyword>
  <keyword>adoption</keyword>
  <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/NCT04443504
org study id: 1920-217
nct id: NCT04443504
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current study aims to examine the effectiveness of an online, self-paced post-adoption
      intervention to improve understanding, well-being, and connection within adoptive families.To
      evaluate the effectiveness of this intervention, a mixed method, pre-post design with two
      conditions will be used. Data from standard, reliable measures and free-response items will
      be collected pre- and post-intervention from participants in two conditions: the intervention
      condition and the waitlist condition. The intervention condition involves receiving the
      intervention immediately following pre-assessments; the waitlist condition involves receiving
      the intervention approximately 3 months after the intervention condition once all data
      collection is completed.

      The study aims to answer six research questions. Each research question involves analyses of
      the differences between the intervention and waitlist conditions across multiple time points.

        1. What is the intervention's effect on improving awareness of the needs of different
           family members and understanding how to meet these needs? Hypothesis 1: At
           post-intervention, parents in the intervention condition will report an improved
           awareness of the needs of each family member and greater understanding of how to meet
           these needs.

        2. What is the intervention's effect on parent well-being (i.e., parenting confidence and
           parenting stress) from pre- to post-intervention? Hypothesis 2: Parents in the
           intervention condition will report increased parenting confidence and trending decreases
           in parenting stress from pre- to post-intervention compared to those in the waitlist
           condition.

        3. What is the intervention's effect on child well-being (i.e., self-esteem and emotional
           and behavioral problems) from pre- to post-intervention? Hypothesis 3: Children in the
           intervention condition will report increased self-esteem and trending decreases in
           emotional and behavioral problems from pre- to post-intervention compared to those in
           the waitlist condition.

        4. What is the intervention's effect on the quality of the parent-child relationship from
           pre- to post-intervention? Hypothesis 4: Both parents and children in the intervention
           condition will report improved connection in the parent-child relationship from pre- to
           post-intervention compared to those in the waitlist condition.

        5. As an exploratory question, what is the intervention's effect on the quality of the
           sibling relationship from pre- to post-intervention? Hypothesis 5: Children in the
           intervention condition will report an improvement in the quality of their relationship
           with their sibling(s) from pre- to post-intervention compared to children in the
           waitlist condition.

        6. What is the intervention's effect on connection and communication within the overall
           family system from pre- to post-intervention? Hypothesis 6: Parents and children in the
           intervention condition will report increased family communication and family connection
           in the whole family system from pre- to post-intervention compared to parents and
           children in the waitlist condition.
One member of the family will complete a survey to ensure eligibility criteria have been met.
      In the recruitment application, the individual who completes the application will include an
      email address to be used as the primary contact person for the family. If the family meets
      the eligibility criteria, the primary contact person will receive consent forms to complete
      for each member of the family. Once consent forms are completed for the entire family and
      each member has agreed to participate in research, the primary contact will complete a
      demographic survey of basic household information. In the demographic survey, the primary
      contact will include email addresses for each family member 18 years and older. See timeline
      below for reference. *Note: dates are approximate.

      Once consented, online surveys of pre-assessments will be sent to families via email (via
      individual links; survey links for children under 18 will be sent to the primary contact).
      Pre-assessments include individual, dyad, and family measures to examine the effectiveness of
      the intervention in multiple systems of the family. Each family member who is 12 years and
      older will complete pre-assessments during a one-week data collection period.

      After pre-assessments are complete, families will be randomly assigned to the intervention or
      waitlist condition using a random number generator, and families will be notified of their
      assigned condition.

      Both the waitlist and intervention condition will complete pre-assessments.

      Once the pre-assessment data collection period is complete, families in the intervention
      condition will have one week before the intervention begins. The primary contact of families
      assigned to the intervention condition will receive an email with instructions to register
      and to prepare for the 4-week intervention series. The waitlist condition will do nothing
      during this time.

      One week after pre-assessment data collection is complete, the 4-week intervention series
      will begin. The intervention includes 4 weekly sessions. Each weekly session involves parents
      watching a 15-minute mini-webinar, children watching a 5-minute video, parents and children
      12 years and older completing separate reflection questions (*note these questions will be
      used as data for analysis), and families completing two family activities together (an
      activity aimed at improving connection and an activity aimed at improving communication). The
      primary contact will complete a checklist of which activities were completed that week. The
      intervention should take approximately 1.5-3 hours each week for the whole family for a total
      of 6-12 hours over the 4-week period.

      The intervention condition will complete the first week's activities at their own pace within
      the seven days. On each subsequent Monday of the four weeks, the next week's activities will
      open for the intervention condition to access. The previous weeks' activities will still be
      available to the families during the duration of the intervention. All intervention
      activities will be completed within the four-week time period.

      Two weeks after the intervention condition completes the intervention series,
      post-assessments will be sent to both the intervention and waitlist conditions.
      Post-assessments will be the same as the pre-assessments in order to examine differences
      between pre- and post-intervention. Families will have a one-week period to complete the
      post-assessments.

      Three months after the intervention condition completed the intervention, 3-month follow-up
      assessments will be sent to both the intervention and waitlist conditions. 3-month follow-up
      assessments will be the same as the pre- and post-assessments. This follow-up data collection
      period is to determine any longer-term changes that may occur in the family systems
      post-intervention that may not occur closely following the intervention at the
      post-intervention data collection time point. Families will have a one-week period to
      complete the 3-month follow-up assessments.

      One week after the three-month follow-up data collection period is completed, families
      randomly assigned to the waitlist condition will receive the invitation to register for the
      intervention. The waitlist condition will receive instructions to register for the
      intervention and to prepare for the 4-week intervention series. The waitlist condition will
      receive the intervention series in the same order and manner as the intervention condition.

      Approximately 6 months after the intervention condition completed the intervention, the
      intervention condition will complete 6-month follow-up assessments. This follow-up data
      collection is to determine the long-term changes that may occur in the family system
      post-intervention. Only the intervention condition will complete this data collection period
      as the waitlist condition would have completed the intervention at this time.

      In total, participation in this study will take approximately 15-20 hours during a 6-month
      period with approximately 4 hours total to complete surveys and assessments and 6-15 hours to
      participate in the intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups will be created using random assignment: an intervention group and a waitlist control group who will receive the intervention 3 months after the intervention group
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Family Cohesion
time frame: through study completion, an average of 6 months
description: Family Adaptability and Cohesion Scale IV
measure: Change in Parent and Child Relationship
time frame: through study completion, an average of 6 months
description: Inventory of Parent and Peer Attachment-Revised, Child-Parent Relationship Scale-Short Form
measure: Change in Parenting Stress
time frame: through study completion, an average of 6 months
description: Parental Stress Scale
measure: Change in Parenting Competence
time frame: through study completion, an average of 6 months
description: Parenting Sense of Competence Scale
measure: Change in Child Self-Esteem
time frame: through study completion, an average of 6 months
description: Rosenberg Self-Esteem Scale
measure: Change in Child Emotional and Behavioral Problems
time frame: through study completion, an average of 6 months
description: Strengths & Difficulties Questionnaire
measure: Change in Sibling Relationship
time frame: through study completion, an average of 6 months
description: Sibling Relationship Questionnaire
arm group label: Intervention Group
arm group type: Experimental
arm group label: Waitlist Group
arm group type: No Intervention
description: The waitlist group will receive the intervention 3 months after the intervention group.
intervention type: Behavioral
intervention name: The Connected Family Series
description: The intervention is an online, self-paced post-adoption family intervention that occurs over a 4-week period to support adoptive families post-adoption.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Texas Christian University
investigator full name: Jana Hunsley
investigator title: Graduate Research Assistant
sharing ipd: No