<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/NCT02979262</url>
  </required_header>
  <id_info>
    <org_study_id>1R34DA038763-01A1</org_study_id>
    <secondary_id>1R34DA038763-01A1</secondary_id>
    <nct_id>NCT02979262</nct_id>
  </id_info>
  <brief_title>Intimate Partner Violence and Fatherhood Intervention in Residential Substance Abuse Treatment</brief_title>
  <official_title>IPV and Fatherhood Intervention in Residential Substance Abuse Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Florida</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed stage 1 intervention development study is designed to address two significant&#xD;
      co-occurring issues for fathers with substance abuse (SA) problems: Intimate partner violence&#xD;
      (IPV) and child maltreatment (CM). SA treatment programs are an important avenue to reduce&#xD;
      family violence because SA treatment alone does not result in an end to these behaviors.&#xD;
      Currently available interventions have had little success in reducing male IPV. Fathers for&#xD;
      Change, an integrated outpatient intervention, shows promise as an intervention model&#xD;
      targeting the intersection of SA, IPV, and CM. The intervention uses men's roles as fathers&#xD;
      as a motivation for change and targets factors that are known to trigger SA, IPV and CM:&#xD;
      hostile cognitions and poor emotion regulation. An intervention of this sort has not been&#xD;
      integrated and tested as part of a residential substance abuse program for men. This project&#xD;
      is a pilot study of 60 fathers randomly assigned to Fathers for Change or a Parent Education&#xD;
      Program (PE) comparison. The initial feasibility of the Fathers for Change will be assessed&#xD;
      by comparing it to PE in the areas of: participant completion rates, hostile cognitions,&#xD;
      emotion regulation, SA relapse, IPV, and CM risk behaviors (negative parenting). Change in&#xD;
      hostile cognitions and emotion regulation will be examined as the mechanisms through which&#xD;
      Fathers for Change reduces relapse, IPV and CM risk behaviors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hostile Thoughts on the Articulated Thoughts in Simulated Situations Task</measure>
    <time_frame>Baseline and intervention completion around 16 weeks</time_frame>
    <description>Hostile Thinking coded from audio recorded transcripts. Participants are presented with 4 scenarios in which they are asked to respond verbally their thoughts about a given situation. The scenarios present incidents that could induce feelings of jealousy, anger, abandonment, or disrespect. These are coded for number of hostile cognitions by trained blind coders and summed for a total score. The range of scores is 0 to 28 . Higher scores mean greater hostile cognitions (worse outcome).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Total Score of the Difficulties With Emotion Regulation Scale (DERS)</measure>
    <time_frame>Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28</time_frame>
    <description>Emotion regulation difficulties are measured using this standardized self-report measure and a total score is calculated by summing the items. Score range is 0 to 180 with higher scores meaning worse outcome. Change over time is reported as the slope.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Number of Domestic Violence Episodes on the Timeline Follow-Back Calendars</measure>
    <time_frame>Baseline through 3 month follow-up after intervention</time_frame>
    <description>Domestic Violence including physical and psychological aggression episodes across the length of followup. Higher scores mean more violence. Scores can range from 0 to 210 days. Change over time is reported as the slope.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Score on the Adult Adolescent Parenting Inventory</measure>
    <time_frame>Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28</time_frame>
    <description>Overall score is indicator of maltreatment risk. A total score is calculated by summing the 5 scales with lower scores indicating greater risk for maltreatment. The range of scores is from 40 to 200. Change over time is reported as the slope.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Coparenting Relationship Scale</measure>
    <time_frame>Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28</time_frame>
    <description>Brief Coparenting score which is calculated from a sum of 14 scale items. Scores range from 0 to 84 with higher scores indicating better coparenting. Change over time is reported as the slope.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Days of Substance Use Reported on the Time Line Follow-Back Calendars</measure>
    <time_frame>At intervention completion (around week 16) and 3 months post intervention (at around 28 weeks)</time_frame>
    <description>Number of days of substance use over the course of the study. Higher scores equal more days of substance use. Possible range of scores was from 0 to 210 days. Change over time is reported as the slope.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Intimate Partner Violence</condition>
  <condition>Substance Abuse/Addiction</condition>
  <condition>Child Maltreatment</condition>
  <arm_group>
    <arm_group_label>Fathers for Change</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parent Education (PE)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fathers for Change</intervention_name>
    <arm_group_label>Fathers for Change</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent Education</intervention_name>
    <arm_group_label>Parent Education (PE)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. meet current DSM-5 criteria for substance use disorder of alcohol, cocaine, marijuana,&#xD;
             amphetamines, or opiates at the time of admission to Westcare; (2) report physical&#xD;
             violence in an intimate relationship (pushing, slapping, kicking) within 6 months of&#xD;
             admission to the program (based on court/police records or self- report); and (3) have&#xD;
             at least one biological child under the age of 12 with whom they lived or had at least&#xD;
             once per month visitation prior to admission to Westcare. Each will agree to have&#xD;
             their female co-parents contacted for participation as collateral informants and will&#xD;
             provide the contact information. If a participant has more than one child in the age&#xD;
             range, the youngest child will be the target of assessment. Female co-parents (the&#xD;
             target children's mothers) will be invited to participate as collateral informants on&#xD;
             research assessments and to participate in a portion (2 -4) of the intervention&#xD;
             sessions. If a female co-parent does not consent to participate, a male participant&#xD;
             will still be allowed to enroll in the study if he meets eligibility criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals will be excluded who: 1) Have histories of severe physical violence (e.g.&#xD;
             strangulation, causing hospitalization) based on police records, self or partner&#xD;
             reports; 2) Men who have an active FULL/NO CONTACT protective order pertaining to&#xD;
             their partner or child (Westcare has access to criminal record/court information for&#xD;
             all of it's residential clients. Participants will sign releases of information during&#xD;
             informed consent to allow the study team to access this information to determine&#xD;
             eligibility); 3) Have cognitive impairment (a mini mental state score &lt;25); 4) Have&#xD;
             major medical complications such as a head injury or HIV dementia that may also be a&#xD;
             confound in the study interventions; 5) Have current untreated psychotic or bipolar&#xD;
             disorder (reported by history, as part of the Westcare record, or self-report); or 6)&#xD;
             Are currently suicidal or homicidal. If potential participants have a prior diagnosis&#xD;
             of bipolar or psychotic disorder that is currently treated and symptoms are well&#xD;
             managed based on initial study interview and after collateral contact with the&#xD;
             Westcare treatment team, they may participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Westcare Inc. Davis Bradley Building</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 4, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>March 26, 2019</results_first_submitted>
  <results_first_submitted_qc>November 12, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 2, 2019</results_first_posted>
  <last_update_submitted>November 12, 2019</last_update_submitted>
  <last_update_submitted_qc>November 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT02979262/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT02979262/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Fathers were recruited from two 6-month men's residential substance use treatment facilities. Both programs followed a 12-step facilitation therapeutic milieu approach. Information about the study was provided by facility staff to men who entered the facility, completed 30 days of treatment and had a biological child under the age of 16.</recruitment_details>
      <pre_assignment_details>Screening: 1) had some contact with his children via phone, letters or in person visits; 2) reported either physical or psychological aggression toward his female co-parent in the last 12 months; and 3) could complete study interviews and intervention in English. Eligible men met individually with an RA to complete baseline measures.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Fathers for Change</title>
          <description>Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.&#xD;
Fathers for Change</description>
        </group>
        <group group_id="P2">
          <title>Parent Education (PE)</title>
          <description>PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.&#xD;
Parent Education</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Allocated Intervention</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fathers for Change</title>
          <description>Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.&#xD;
Fathers for Change</description>
        </group>
        <group group_id="B2">
          <title>Parent Education (PE)</title>
          <description>PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.&#xD;
Parent Education</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
            <count group_id="B2" value="29"/>
            <count group_id="B3" value="62"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.82" spread="9.07"/>
                    <measurement group_id="B2" value="34.76" spread="6.28"/>
                    <measurement group_id="B3" value="35.85" spread="7.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnic Minority</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Child Abuse History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Physical Abuse History</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sexual Abuse History</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychological Abuse History</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current contact with partner</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Residence with target child before treatment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Physical violence toward coparent</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Hostile Thoughts on the Articulated Thoughts in Simulated Situations Task</title>
        <description>Hostile Thinking coded from audio recorded transcripts. Participants are presented with 4 scenarios in which they are asked to respond verbally their thoughts about a given situation. The scenarios present incidents that could induce feelings of jealousy, anger, abandonment, or disrespect. These are coded for number of hostile cognitions by trained blind coders and summed for a total score. The range of scores is 0 to 28 . Higher scores mean greater hostile cognitions (worse outcome).</description>
        <time_frame>Baseline and intervention completion around 16 weeks</time_frame>
        <population>Participants completed this assessment at baseline and 16 weeks only. We had some participants who refused to complete this specific measure at the post assessment and therefore we have less participants for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Fathers for Change</title>
            <description>Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.&#xD;
Fathers for Change</description>
          </group>
          <group group_id="O2">
            <title>Parent Education (PE)</title>
            <description>PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.&#xD;
Parent Education</description>
          </group>
        </group_list>
        <measure>
          <title>Hostile Thoughts on the Articulated Thoughts in Simulated Situations Task</title>
          <description>Hostile Thinking coded from audio recorded transcripts. Participants are presented with 4 scenarios in which they are asked to respond verbally their thoughts about a given situation. The scenarios present incidents that could induce feelings of jealousy, anger, abandonment, or disrespect. These are coded for number of hostile cognitions by trained blind coders and summed for a total score. The range of scores is 0 to 28 . Higher scores mean greater hostile cognitions (worse outcome).</description>
          <population>Participants completed this assessment at baseline and 16 weeks only. We had some participants who refused to complete this specific measure at the post assessment and therefore we have less participants for analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time 1-Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.00" spread="1.90"/>
                    <measurement group_id="O2" value="7.62" spread="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 2 - 16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.36" spread="1.43"/>
                    <measurement group_id="O2" value="4.23" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;.10</p_value>
            <method>Repeated Measures GLM</method>
            <method_desc>Time 2 at 16 weeks</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Total Score of the Difficulties With Emotion Regulation Scale (DERS)</title>
        <description>Emotion regulation difficulties are measured using this standardized self-report measure and a total score is calculated by summing the items. Score range is 0 to 180 with higher scores meaning worse outcome. Change over time is reported as the slope.</description>
        <time_frame>Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fathers for Change</title>
            <description>Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.&#xD;
Fathers for Change</description>
          </group>
          <group group_id="O2">
            <title>Parent Education (PE)</title>
            <description>PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.&#xD;
Parent Education</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Score of the Difficulties With Emotion Regulation Scale (DERS)</title>
          <description>Emotion regulation difficulties are measured using this standardized self-report measure and a total score is calculated by summing the items. Score range is 0 to 180 with higher scores meaning worse outcome. Change over time is reported as the slope.</description>
          <units>ratio score baseline to 28 weeks</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.31" spread=".13"/>
                    <measurement group_id="O2" value="-.21" spread=".12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.01</p_value>
            <method>GEE</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Number of Domestic Violence Episodes on the Timeline Follow-Back Calendars</title>
        <description>Domestic Violence including physical and psychological aggression episodes across the length of followup. Higher scores mean more violence. Scores can range from 0 to 210 days. Change over time is reported as the slope.</description>
        <time_frame>Baseline through 3 month follow-up after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fathers for Change</title>
            <description>Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.&#xD;
Fathers for Change</description>
          </group>
          <group group_id="O2">
            <title>Parent Education (PE)</title>
            <description>PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.&#xD;
Parent Education</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Number of Domestic Violence Episodes on the Timeline Follow-Back Calendars</title>
          <description>Domestic Violence including physical and psychological aggression episodes across the length of followup. Higher scores mean more violence. Scores can range from 0 to 210 days. Change over time is reported as the slope.</description>
          <units>ratio score baseline to 28 weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.002" spread=".006"/>
                    <measurement group_id="O2" value="-.01" spread=".007"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;.10</p_value>
            <method>GEE</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Score on the Adult Adolescent Parenting Inventory</title>
        <description>Overall score is indicator of maltreatment risk. A total score is calculated by summing the 5 scales with lower scores indicating greater risk for maltreatment. The range of scores is from 40 to 200. Change over time is reported as the slope.</description>
        <time_frame>Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fathers for Change</title>
            <description>Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.&#xD;
Fathers for Change</description>
          </group>
          <group group_id="O2">
            <title>Parent Education (PE)</title>
            <description>PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.&#xD;
Parent Education</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Score on the Adult Adolescent Parenting Inventory</title>
          <description>Overall score is indicator of maltreatment risk. A total score is calculated by summing the 5 scales with lower scores indicating greater risk for maltreatment. The range of scores is from 40 to 200. Change over time is reported as the slope.</description>
          <units>ratio score baseline to 28 weeks</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".12" spread=".07"/>
                    <measurement group_id="O2" value=".03" spread=".07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;.10</p_value>
            <method>GEE</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Coparenting Relationship Scale</title>
        <description>Brief Coparenting score which is calculated from a sum of 14 scale items. Scores range from 0 to 84 with higher scores indicating better coparenting. Change over time is reported as the slope.</description>
        <time_frame>Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fathers for Change</title>
            <description>Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.&#xD;
Fathers for Change</description>
          </group>
          <group group_id="O2">
            <title>Parent Education (PE)</title>
            <description>PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.&#xD;
Parent Education</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Coparenting Relationship Scale</title>
          <description>Brief Coparenting score which is calculated from a sum of 14 scale items. Scores range from 0 to 84 with higher scores indicating better coparenting. Change over time is reported as the slope.</description>
          <units>ratio score baseline to 28 weeks</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread=".11"/>
                    <measurement group_id="O2" value="0.02" spread=".08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;.10</p_value>
            <method>GEE</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Days of Substance Use Reported on the Time Line Follow-Back Calendars</title>
        <description>Number of days of substance use over the course of the study. Higher scores equal more days of substance use. Possible range of scores was from 0 to 210 days. Change over time is reported as the slope.</description>
        <time_frame>At intervention completion (around week 16) and 3 months post intervention (at around 28 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fathers for Change</title>
            <description>Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.&#xD;
Fathers for Change</description>
          </group>
          <group group_id="O2">
            <title>Parent Education (PE)</title>
            <description>PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.&#xD;
Parent Education</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Days of Substance Use Reported on the Time Line Follow-Back Calendars</title>
          <description>Number of days of substance use over the course of the study. Higher scores equal more days of substance use. Possible range of scores was from 0 to 210 days. Change over time is reported as the slope.</description>
          <units>ratio score baseline to 28 weeks</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".01" spread=".01"/>
                    <measurement group_id="O2" value=".03" spread=".03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.01</p_value>
            <method>GEE</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 8 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Fathers for Change</title>
          <description>Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.&#xD;
Fathers for Change</description>
        </group>
        <group group_id="E2">
          <title>Parent Education (PE)</title>
          <description>PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.&#xD;
Parent Education</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Child Protective Services Report</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <description>Father in the study reported child neglect of his children who were in the care of his step-father prompting a child protective services report.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric hospitalization of child associated with study</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Participant Arrested and Jailed</sub_title>
                <description>Arrest due to probation violation, new drug charge or other reason resulting in jail time.</description>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="33"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Carla Stover</name_or_title>
      <organization>Yale University Child Study Center</organization>
      <phone>2037853486</phone>
      <email>carla.stover@yale.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02979262
org study id: 1R34DA038763-01A1
secondary id: 1R34DA038763-01A1
nct id: NCT02979262
lead sponsor: 
collaborator: 
has dmc: Yes
The proposed stage 1 intervention development study is designed to address two significant
      co-occurring issues for fathers with substance abuse (SA) problems: Intimate partner violence
      (IPV) and child maltreatment (CM). SA treatment programs are an important avenue to reduce
      family violence because SA treatment alone does not result in an end to these behaviors.
      Currently available interventions have had little success in reducing male IPV. Fathers for
      Change, an integrated outpatient intervention, shows promise as an intervention model
      targeting the intersection of SA, IPV, and CM. The intervention uses men's roles as fathers
      as a motivation for change and targets factors that are known to trigger SA, IPV and CM:
      hostile cognitions and poor emotion regulation. An intervention of this sort has not been
      integrated and tested as part of a residential substance abuse program for men. This project
      is a pilot study of 60 fathers randomly assigned to Fathers for Change or a Parent Education
      Program (PE) comparison. The initial feasibility of the Fathers for Change will be assessed
      by comparing it to PE in the areas of: participant completion rates, hostile cognitions,
      emotion regulation, SA relapse, IPV, and CM risk behaviors (negative parenting). Change in
      hostile cognitions and emotion regulation will be examined as the mechanisms through which
      Fathers for Change reduces relapse, IPV and CM risk behaviors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Hostile Thoughts on the Articulated Thoughts in Simulated Situations Task
time frame: Baseline and intervention completion around 16 weeks
description: Hostile Thinking coded from audio recorded transcripts. Participants are presented with 4 scenarios in which they are asked to respond verbally their thoughts about a given situation. The scenarios present incidents that could induce feelings of jealousy, anger, abandonment, or disrespect. These are coded for number of hostile cognitions by trained blind coders and summed for a total score. The range of scores is 0 to 28 . Higher scores mean greater hostile cognitions (worse outcome).
measure: Change in Total Score of the Difficulties With Emotion Regulation Scale (DERS)
time frame: Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28
description: Emotion regulation difficulties are measured using this standardized self-report measure and a total score is calculated by summing the items. Score range is 0 to 180 with higher scores meaning worse outcome. Change over time is reported as the slope.
measure: Change in Number of Domestic Violence Episodes on the Timeline Follow-Back Calendars
time frame: Baseline through 3 month follow-up after intervention
description: Domestic Violence including physical and psychological aggression episodes across the length of followup. Higher scores mean more violence. Scores can range from 0 to 210 days. Change over time is reported as the slope.
measure: Change in Total Score on the Adult Adolescent Parenting Inventory
time frame: Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28
description: Overall score is indicator of maltreatment risk. A total score is calculated by summing the 5 scales with lower scores indicating greater risk for maltreatment. The range of scores is from 40 to 200. Change over time is reported as the slope.
measure: Change in Coparenting Relationship Scale
time frame: Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28
description: Brief Coparenting score which is calculated from a sum of 14 scale items. Scores range from 0 to 84 with higher scores indicating better coparenting. Change over time is reported as the slope.
measure: Change in Days of Substance Use Reported on the Time Line Follow-Back Calendars
time frame: At intervention completion (around week 16) and 3 months post intervention (at around 28 weeks)
description: Number of days of substance use over the course of the study. Higher scores equal more days of substance use. Possible range of scores was from 0 to 210 days. Change over time is reported as the slope.
arm group label: Fathers for Change
arm group type: Experimental
description: Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.
arm group label: Parent Education (PE)
arm group type: Active Comparator
description: PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.
intervention type: Behavioral
intervention name: Fathers for Change
arm group label: Fathers for Change
intervention type: Behavioral
intervention name: Parent Education
arm group label: Parent Education (PE)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
sharing ipd: Undecided
provided document: 
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certain agreements: 
point of contact: 