<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/NCT04456738</url>
  </required_header>
  <id_info>
    <org_study_id>KEEP60195</org_study_id>
    <secondary_id>R01MH060195</secondary_id>
    <nct_id>NCT04456738</nct_id>
  </id_info>
  <brief_title>Cascading Dissemination of a Foster Parent Intervention</brief_title>
  <acronym>KEEP</acronym>
  <official_title>Cascading Dissemination of a Foster Parent Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Social Learning Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon Social Learning Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of this study is to test the effectiveness of KEEP (Keeping Foster Parents&#xD;
      Supported and Trained), an intervention intended to increase supports and consultation to&#xD;
      foster parents, and to evaluate the transferability of the proposed intervention from Oregon&#xD;
      to the foster care system in San Diego.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children in the foster care system are growing in number, are at high risk for psychological&#xD;
      problems, and are increasingly challenging to their foster parents. Foster parents who are&#xD;
      trying to provide care and nurturing to these children are often doing so without benefit or&#xD;
      meaningful or relevant consultation on developmental and mental health issues. The study&#xD;
      tests the effectiveness of an intervention intended to increase supports and consultation to&#xD;
      foster parents. A major aim of this study was to test the transferability of the proposed&#xD;
      intervention from Oregon to the foster care system in San Diego in 3 regions of Health and&#xD;
      Human Services. A cascading dissemination model will be employed, where the original&#xD;
      developers train and supervise staff in San Diego to implement the intervention, and in the&#xD;
      second iteration of the of the intervention, the involvement of the original developers&#xD;
      lessened. The intervention is designed to provide foster parents with general support and&#xD;
      specific parent management training (PMT), a well-documented and effective intervention&#xD;
      approach. In a previous efficacy trial, PMT had positive effects with foster parents in three&#xD;
      areas: 1) reduction of child symptoms, 2) lower rates of disruption in foster care (changes&#xD;
      in placements for negative reasons), and 3) fewer foster parents in the PMT condition dropped&#xD;
      out of providing foster care. Outcomes will be evaluated at multiple levels, including child&#xD;
      symptoms, functional behavior, environments, consumer perspectives, and system using a&#xD;
      multi-method/multi-agent strategy. Implementation fidelity will be assessed, as will&#xD;
      contextual factors, including the organizational climate and social isolation/insularity of&#xD;
      the foster parents. It is hypothesized that, compared to controls, foster parents in the&#xD;
      intervention group will improve on parenting skills, feel more supported, and have less&#xD;
      stress, which in turn will result in more positive child outcomes, including fewer reported&#xD;
      child symptoms and higher levels of child functional behavior in three domains (i.e., home,&#xD;
      school, with peers). Improvements in foster parent outcomes and child outcomes are both&#xD;
      hypothesized to predict system-level outcomes, including child use of mental health services,&#xD;
      foster parent retention, and placement disruptions. Contextual factors are expected to impact&#xD;
      foster parent outcomes directly and child and system outcomes indirectly, through&#xD;
      implementation fidelity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2000</start_date>
  <completion_date type="Actual">June 2005</completion_date>
  <primary_completion_date type="Actual">June 2005</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in placement disruptions rates for foster placements</measure>
    <time_frame>18 months post baseline</time_frame>
    <description>Using child welfare system placement records, rates of disruptions for pre and post time frames are calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in child behavior problems as assessed by the Parent Daily Report (PDR)</measure>
    <time_frame>Baseline, 6 months-, 12 months-, and 18 months post baseline</time_frame>
    <description>The PDR is a brief telephone interview that collects data the number problem behaviors that occurred in the previous 24 hours. This measure is repeated three times at each wave.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in rates of reunification with Biological Family as assessed by child welfare system placement records</measure>
    <time_frame>Baseline through 18 months post baseline</time_frame>
    <description>Using child welfare system placement records, rates of reunification between baseline and 18 months are calculated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">704</enrollment>
  <condition>Child Welfare</condition>
  <condition>Foster Home Care</condition>
  <arm_group>
    <arm_group_label>Parent Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>16 weeks of parent training in a group context with 5 to 10 relative and non-relative foster caregivers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Services as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Foster care services as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent Training</intervention_name>
    <description>16 weeks of of parent training led by a trained group facilitator</description>
    <arm_group_label>Parent Training</arm_group_label>
    <other_name>Parent Management Training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any child between ages 5 and 12 years in relative or non-relative foster care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Only medically fragile children&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patricia Chamberlain, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Social Learning Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Child and Adolescent Services Research Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Social Learning Center</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Price JM, Chamberlain P, Landsverk J, Reid JB, Leve LD, Laurent H. Effects of a foster parent training intervention on placement changes of children in foster care. Child Maltreat. 2008 Feb;13(1):64-75. doi: 10.1177/1077559507310612.</citation>
    <PMID>18174349</PMID>
  </reference>
  <reference>
    <citation>Chamberlain P, Price JM, Reid JB, Landsverk J, Fisher PA, Stoolmiller M. Who disrupts from placement in foster and kinship care? Child Abuse Negl. 2006 Apr;30(4):409-24. doi: 10.1016/j.chiabu.2005.11.004. Epub 2006 Apr 5.</citation>
    <PMID>16600372</PMID>
  </reference>
  <reference>
    <citation>Chamberlain P, Price J, Reid J, Landsverk J. Cascading implementation of a foster and kinship parent intervention. Child Welfare. 2008;87(5):27-48.</citation>
    <PMID>19402358</PMID>
  </reference>
  <reference>
    <citation>Chamberlain P, Price J, Leve LD, Laurent H, Landsverk JA, Reid JB. Prevention of behavior problems for children in foster care: outcomes and mediation effects. Prev Sci. 2008 Mar;9(1):17-27. doi: 10.1007/s11121-007-0080-7. Epub 2008 Jan 10.</citation>
    <PMID>18185995</PMID>
  </reference>
  <reference>
    <citation>Degarmo DS, Chamberlain P, Leve LD, Price J. Foster Parent Intervention Engagement Moderating Child Behavior Problems and Placement Disruption. Res Soc Work Pract. 2009 Jul 1;19(4):423-433. doi: 10.1177/1049731508329407.</citation>
    <PMID>20072708</PMID>
  </reference>
  <results_reference>
    <citation>Price, J., Chamberlain, P., Landsverk, J., &amp; Reid, J. B. (2010). KEEP foster parent training intervention: Model description and effectiveness. Child and Family Social Work, 14, 233-242.</citation>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>February 29, 2012</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>child behavior</keyword>
  <keyword>parent training</keyword>
  <!-- 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/NCT04456738
org study id: KEEP60195
secondary id: R01MH060195
nct id: NCT04456738
lead sponsor: 
collaborator: 
has dmc: No
The primary goal of this study is to test the effectiveness of KEEP (Keeping Foster Parents
      Supported and Trained), an intervention intended to increase supports and consultation to
      foster parents, and to evaluate the transferability of the proposed intervention from Oregon
      to the foster care system in San Diego.
Children in the foster care system are growing in number, are at high risk for psychological
      problems, and are increasingly challenging to their foster parents. Foster parents who are
      trying to provide care and nurturing to these children are often doing so without benefit or
      meaningful or relevant consultation on developmental and mental health issues. The study
      tests the effectiveness of an intervention intended to increase supports and consultation to
      foster parents. A major aim of this study was to test the transferability of the proposed
      intervention from Oregon to the foster care system in San Diego in 3 regions of Health and
      Human Services. A cascading dissemination model will be employed, where the original
      developers train and supervise staff in San Diego to implement the intervention, and in the
      second iteration of the of the intervention, the involvement of the original developers
      lessened. The intervention is designed to provide foster parents with general support and
      specific parent management training (PMT), a well-documented and effective intervention
      approach. In a previous efficacy trial, PMT had positive effects with foster parents in three
      areas: 1) reduction of child symptoms, 2) lower rates of disruption in foster care (changes
      in placements for negative reasons), and 3) fewer foster parents in the PMT condition dropped
      out of providing foster care. Outcomes will be evaluated at multiple levels, including child
      symptoms, functional behavior, environments, consumer perspectives, and system using a
      multi-method/multi-agent strategy. Implementation fidelity will be assessed, as will
      contextual factors, including the organizational climate and social isolation/insularity of
      the foster parents. It is hypothesized that, compared to controls, foster parents in the
      intervention group will improve on parenting skills, feel more supported, and have less
      stress, which in turn will result in more positive child outcomes, including fewer reported
      child symptoms and higher levels of child functional behavior in three domains (i.e., home,
      school, with peers). Improvements in foster parent outcomes and child outcomes are both
      hypothesized to predict system-level outcomes, including child use of mental health services,
      foster parent retention, and placement disruptions. Contextual factors are expected to impact
      foster parent outcomes directly and child and system outcomes indirectly, through
      implementation fidelity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Change in placement disruptions rates for foster placements
time frame: 18 months post baseline
description: Using child welfare system placement records, rates of disruptions for pre and post time frames are calculated.
measure: Change in child behavior problems as assessed by the Parent Daily Report (PDR)
time frame: Baseline, 6 months-, 12 months-, and 18 months post baseline
description: The PDR is a brief telephone interview that collects data the number problem behaviors that occurred in the previous 24 hours. This measure is repeated three times at each wave.
measure: Change in rates of reunification with Biological Family as assessed by child welfare system placement records
time frame: Baseline through 18 months post baseline
description: Using child welfare system placement records, rates of reunification between baseline and 18 months are calculated.
arm group label: Parent Training
arm group type: Experimental
description: 16 weeks of parent training in a group context with 5 to 10 relative and non-relative foster caregivers
arm group label: Services as Usual
arm group type: No Intervention
description: Foster care services as usual
intervention type: Behavioral
intervention name: Parent Training
description: 16 weeks of of parent training led by a trained group facilitator
arm group label: Parent Training
other name: Parent Management Training
criteria: 
gender: All
minimum age: 5 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Patricia Chamberlain, PhD
role: Principal Investigator
affiliation: Oregon Social Learning Center
facility: 
facility: 
country: United States
citation: Price JM, Chamberlain P, Landsverk J, Reid JB, Leve LD, Laurent H. Effects of a foster parent training intervention on placement changes of children in foster care. Child Maltreat. 2008 Feb;13(1):64-75. doi: 10.1177/1077559507310612.
PMID: 18174349
citation: Chamberlain P, Price JM, Reid JB, Landsverk J, Fisher PA, Stoolmiller M. Who disrupts from placement in foster and kinship care? Child Abuse Negl. 2006 Apr;30(4):409-24. doi: 10.1016/j.chiabu.2005.11.004. Epub 2006 Apr 5.
PMID: 16600372
citation: Chamberlain P, Price J, Reid J, Landsverk J. Cascading implementation of a foster and kinship parent intervention. Child Welfare. 2008;87(5):27-48.
PMID: 19402358
citation: Chamberlain P, Price J, Leve LD, Laurent H, Landsverk JA, Reid JB. Prevention of behavior problems for children in foster care: outcomes and mediation effects. Prev Sci. 2008 Mar;9(1):17-27. doi: 10.1007/s11121-007-0080-7. Epub 2008 Jan 10.
PMID: 18185995
citation: Degarmo DS, Chamberlain P, Leve LD, Price J. Foster Parent Intervention Engagement Moderating Child Behavior Problems and Placement Disruption. Res Soc Work Pract. 2009 Jul 1;19(4):423-433. doi: 10.1177/1049731508329407.
PMID: 20072708
citation: Price, J., Chamberlain, P., Landsverk, J., & Reid, J. B. (2010). KEEP foster parent training intervention: Model description and effectiveness. Child and Family Social Work, 14, 233-242.
responsible party type: Sponsor