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Pathways for Parents After Incarceration Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04525703
Recruitment Status : Completed
First Posted : August 25, 2020
Last Update Posted : May 26, 2022
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE August 20, 2020
First Posted Date  ICMJE August 25, 2020
Last Update Posted Date May 26, 2022
Actual Study Start Date  ICMJE September 16, 2020
Actual Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
  • Proportion of eligible fathers and caregivers who consent [ Time Frame: baseline ]
    The feasibility of this approach will in part be measured by successful recruitment of participants from this population. This is measured by the proportion of eligible fathers and caregivers who consent to study participation and enrollment.
  • Proportion of enrolled fathers and caregivers who complete entire intervention [ Time Frame: up to 9 weeks ]
    The feasibility of this approach will in part be measured by the retention of participants in this intervention. This is measured by the proportion of enrolled fathers and caregivers who participate in the first intervention class (after baseline) and complete entire intervention.
  • Provider Adherence Measured by the Parenting Inside Out Group Observation Feedback Form Score [ Time Frame: up to 9 weeks ]
    Adherence is measured using the Parenting Inside Out (PIO) Group Observation Feedback Form to assess program integrity and fidelity to the model. This is a 35-item survey that assesses 5 domains: curriculum delivery and fidelity; facilitation skills, behavior support and group management; interpersonal skills, and PIO specific items. Each item is scored on a scale of 1-5 where 1 is remediation needed, 2 is growth area, 3 is developing, 4 is effective, and 5 is highly effective. Average scores from each domain are reported for a total possible range of scores 5-35, higher scores indicate better adherence.
  • Acceptability of intervention assessed by providers [ Time Frame: up to 9 weeks ]
    Acceptability is assessed by interventionists using an overall rating of the content delivered to participants each week. The overall score is rated on a scale of 1=poor to 10=excellent, with higher scores indicating greater acceptability.
  • Self-Perceived Helpfulness of the Program for the Participant [ Time Frame: up to 21 weeks ]
    Acceptability and usefulness of the intervention is assessed in part by a series of questions that ascertain perceived helpfulness of program for the participant. How helpful was the parenting program for you? 1= Not at all helpful, 2=A little helpful, 3=Somewhat helpful, 4=Quite helpful, 5=Very helpful
  • Participant-Perceived Helpfulness of the Program for the Participant's Child [ Time Frame: up to 21 weeks ]
    Acceptability and usefulness of the intervention is assessed in part by a series of questions that ascertain perceived helpfulness of program for the participant. After your release, how helpful will what you learned in the program be for your child? 1= Not at all helpful, 2=A little helpful, 3=Somewhat helpful, 4=Quite helpful, 5=Very helpful
  • Acceptability of intervention assessed by Participant Recommendation [ Time Frame: up to 21 weeks ]
    Acceptability and usefulness of the intervention is assessed in part by a series of questions that ascertain whether participants would recommend the program to other people. Would you recommend this program to other parents? 1=Strongly recommend, 2=Recommend, 3=Neutral, 4=Not recommend, 5=Strongly not recommend
  • Acceptability of intervention assessed by Parent Satisfaction [ Time Frame: up to 21 weeks ]
    Acceptability and usefulness is assessed by a series of questions that ascertain parent satisfaction. Q: How happy and satisfied you are with being a parent to your child? 1=none, 2=A little, 3=Some, 4=A lot, 5=Very much
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
  • Change in Inventory of Family Feelings Score [ Time Frame: Baseline, 9 weeks, 21 weeks (3 months post-intervention) ]
    Family interactions & relationships will be assessed with the 38-item Inventory of Family Feelings to assess fathers' and caregivers' perceptions of their relationship with another and with their children. Scores range from 0-38, with higher scores indicating more positive affect toward family members and lower scores reflecting conflicted relationships.
  • Change in Coparenting Relationship Scale Score [ Time Frame: Baseline, 9 weeks, 21 weeks (3 months post-intervention) ]
    Coparenting relationship will be assessed with the 11-item Coparenting Relationship Scale. Items are scored on a scale of 1=strongly disagree to 5=strongly agree. Change in mean score will be reported (between 1-5) with higher scores indicative of a stronger coparenting relationship.
  • Change in Kansas Parenting Satisfaction Scale Score [ Time Frame: Baseline, 9 weeks, 21 weeks (3 months post-intervention) ]
    Parenting Satisfaction will be assessed with a 3-item scale, Kansas Parenting Satisfaction Scale. Items are scored on a scale of 1=extremely dissatisfied to 7=extremely satisfied. Change in mean score will be reported (between 1-7) with higher scores indicative of higher levels of parenting satisfaction.
  • Change in Parenting Sense of Competence Scale Score [ Time Frame: Baseline, 9 weeks, 21 weeks (3 months post-intervention) ]
    Parenting competence assessed with the 8-item efficacy subscale of the Parenting Sense of Competence Scale. Items are scored on a scale of 1=strongly disagree 6=strongly agree. Change in mean score will be reported (between 1-6) with higher scores indicative of a stronger sense of parenting efficacy.
  • Change in Alliance Measure Score [ Time Frame: Baseline, 9 weeks, 21 weeks (3 months post-intervention) ]
    Parenting alliance is assessed with the 20-items self-report Parenting Alliance Measure. Items are scored on a 5-point rating scale ranging from 1=strongly disagree to 5=strongly agree. Change in mean score will be reported (between 1-5), with higher scores reflecting stronger coparenting alliances between people.
  • Change in Child-Parent Relationship Scale (CPRS) Score [ Time Frame: Baseline, 9 weeks, 21 weeks (3 months post-intervention) ]
    Assessed with the 15-item Child-Parent Relationship Scale-Short Form to assess perceptions of participants' relationship with their children. Items are scored on a scale of 1=definitely does not apply to 5=definitely applies. Change in mean scores (between 1 and 5) for each subscale over time will be reported, higher scores on each subscale (closeness, conflict) indicative of higher levels of each dimension.
  • Change in Cohen Perceived Stress Scale Score [ Time Frame: Baseline, 9 weeks, 21 weeks (3 months post-intervention) ]
    Stress will be assessed with the 10-item Cohen Perceived Stress Scale. Items are scored on a scale of 0=never to 4=very often. Change in mean score (between 0-4) will be reported, with higher scores reflecting higher levels of stress experienced by the participant.
  • Change in Center for Epidemiologic Studies Depression (CESD) Depression Scale Score [ Time Frame: Baseline, 9 weeks, 21 weeks (3 months post-intervention) ]
    Depression will be assessed with the CESD Depression Scale. Items are scored on a scale of 0=rarely or none of the time (or less than 1 day) to 3=most or all of the time (5-7 days). Change in mean score (between 0-3) will be reported, with higher scores indicating the presence of more depression symptomology.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pathways for Parents After Incarceration Feasibility Study
Official Title  ICMJE Intervention Feasibility Study - Fatherhood After Prison: Healthy Children and Families
Brief Summary The purpose of this study is to learn how to better support fathers and their families after incarceration. It will test an intervention that promotes healthy development for children of previously incarcerated fathers and the caregivers of their children for empirical promise through a pilot feasibility trial. The aims of the pilot are to demonstrate: a) client acceptance of the treatment (e.g., retention), b) ability to recruit sufficient numbers of participants, and c) feasibility of delivery with the clients and therapists in the designated treatment settings. About 15 families (15 fathers, 15 caregivers, and 15-20 children, totaling 45-50 participants) will be in the study.
Detailed Description

The purpose of the overall study, Promoting Healthy Development among Children of Fathers with Antisocial Behavior, is to build and test a preventive family-focused intervention in a feasibility study that promotes healthy development for children of previously incarcerated fathers and the caregivers of their children. The study has three specific aims, two of which have already been completed. The first was to conduct secondary data analyses to explore a series of questions that explored topics including fathers' history of antisocial behavior and criminality, children's psycho-social and behavioral health outcomes, father engagement and parenting behavior, maternal parenting practices, quality of parental relationship, and extended family involvement. The second aim included conducting semi-structured interviews with fathers, mothers, and relatives to improve understanding of the barriers to father engagement and challenges that families face as fathers return to the community following incarceration.

To that end, this protocol situates itself within the third and final aim, that of specifying treatment procedures (e.g., develop manuals, select measures, specify therapist training and adherence procedures) and establishing feasibility of the intervention (e.g., recruitment, enrollment, fidelity, adherence, retention, and safety). Specifically, this protocol is in regard to the feasibility of the intervention. The purpose is to test the intervention for empirical promise through a pilot feasibility trial. The aims of the pilot are to demonstrate: a) client acceptance of the treatment (e.g., retention), b) ability to recruit sufficient numbers of participants, and c) feasibility of delivery with the clients and therapists in the designated treatment settings.

The family intervention is based in a family systems model that includes all members of the family. Multiple family groups are used because previous research has found they are efficient forms of service delivery, build social support among participants, and improve parent-child interactions. Feasibility of the pilot must include all participants anticipated in the program model to test strategies, logistics, and measures. Drawing from the framework of dissemination and implementation science, another central purpose of the pilot is to refine the operational methods that will facilitate translation and implementation in the future should the intervention be found efficacious and effective. This pilot will answer questions that are pertinent to intervention development, as well as the success of dissemination and implementation in the future.

The Intervention:

Pathways for Parents after Incarceration (P4P) is a community-based program that seeks to equip fathers with the skills both for positive father engagement and reentry success. It uses a manualized curriculum that is adapted from a prison-based program, Parenting Inside Out (PIO). PIO is an evidence-based, cognitive-behavioral parent management skills training program created for incarcerated parents through a six-year collaboration of scientists, policy makers, practitioners, and instructional designers. Both the information in the program and the way that information is presented were informed by knowledge derived from research and practice. Extracted from the full 90-hour version, the Pathways for Parents after Incarceration program uses eight key lessons from the original version that have been identified by the research team and those with lived experience as being most beneficial to them. These include topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The course is led by 2 parent coaches who will be interviewed by program leaders and formally trained to deliver PIO by the PIO parent organization, The Pathfinder Network. The classroom-based PIO sessions will be delivered over 8 weeks in two-hour sessions.

In addition to the classroom component that PIO provides, the program will offer a therapeutic component. Weekly, those receiving services from Pathways for Parents after Incarceration will be invited to take part in a peer support group-style group session led by an esteemed provider within the community, Anesis Family Therapy. This component of the program is rooted in systems therapy and uses narrative therapy, trauma focused cognitive therapy, and motivational interviewing techniques. This aspect promotes fathers' and caregivers' ability to identify their values and skills so they can effectively confront the challenges (both instrumental and relational) that they face during their reentry period and as family members working to support the fathers. These sessions run for 45 minutes following the classroom portion.

The program (both classroom and therapeutic peer support) will be offered weekly on a weekday evening for 8 continuous weeks (the 9th week will be a class graduation/celebration). The sessions will be offered virtually to accommodate safety protocols related to the COVID-19 pandemic.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Parenting
  • Development, Child
  • Behavior
Intervention  ICMJE Behavioral: Pathways for Parents after Incarceration
The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.
Study Arms  ICMJE Experimental: Pathways for Parents
Intervention: Behavioral: Pathways for Parents after Incarceration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2022)
47
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2020)
50
Actual Study Completion Date  ICMJE March 31, 2022
Actual Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria (fathers):

  • being able to speak and read English
  • having at least one child between the ages of 3 and 17-years-old
  • having been released from incarceration within the last 5 years (from county jail or state/federal prison)
  • play a parenting role in at least some way (e.g., residence, contact, phone, etc.)

Inclusion Criteria (caregivers):

  • able to speak and read English
  • at least 18-years-old

Exclusion Criteria:

  • have been convicted of a crime against any of his children
  • are prevented from having contact with their child
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04525703
Other Study ID Numbers  ICMJE 2020-0144
A488200 ( Other Identifier: UW Madison )
L&S/SOCIAL WORK/SOC WORK ( Other Identifier: UW Madison )
4R00HD081273-03 ( U.S. NIH Grant/Contract )
Protocol Version 7/8/2021 ( Other Identifier: HSIRB, UW Madison )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Wisconsin, Madison
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Wisconsin, Madison
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Pajarita Charles, PhD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP