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ParentingNCT04525703

Pathways for Parents After Incarceration Feasibility Study

A study testing Pathways for Parents after Incarceration in people with Parenting and Development, Child, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Parenting, Development, Child, Behavior
What is being tested?
Pathways for Parents after Incarceration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
16 Sep 2020to 31 Mar 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • have been convicted of a crime against any of his children
  • are prevented from having contact with their child

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Wisconsin

    Madison, Wisconsin, 53706

Other trials in United States

About this study

Official title: Intervention Feasibility Study - Fatherhood After Prison: Healthy Children and Families

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.

Read the 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.

Being tested
Pathways for Parents after Incarceration
Keywords
incarceration, antisocial behavior, family, child development
Medical subject headings
Behavior, Antisocial Personality Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pathways for Parents after IncarcerationBehavioural

    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 groups in NCT04525703
Study groupRoleWhat they receive
Pathways for ParentsExperimentalNot described
Receives: Behavioral: Pathways for Parents after Incarceration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Eligible Fathers and Caregivers Who Consent

    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.

    Measured: baseline

  2. Proportion of Enrolled Fathers and Caregivers Who Complete Entire Intervention

    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.

    Measured: up to 9 weeks

  3. Provider Adherence Measured by the Parenting Inside Out Group Observation Feedback Form Score

    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 1-5, higher scores indicate better adherence.

    Measured: up to 9 weeks

  4. Acceptability of Intervention Assessed by Providers

    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.

    Measured: up to 9 weeks

  5. Self-Perceived Helpfulness of the Program for the Participant

    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

    Measured: up to 21 weeks

  6. Participant-Perceived Helpfulness of the Program for the Participant's Child

    Acceptability and usefulness of the intervention is assessed in part by a series of questions that ascertain perceived helpfulness of program for the participant.

    "Overall, do you think your participation in this program has had any effect on your child?" 1=has had a very negative effect, 5=has had a very positive effect.

    Measured: up to 21 weeks

  7. Acceptability of Intervention Assessed by Participant Recommendation

    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

    Measured: up to 21 weeks

  8. Acceptability of Intervention Assessed by Parent Satisfaction

    Acceptability and usefulness is assessed by a series of questions that ascertain parent satisfaction.

    Q: How much has the Parenting Inside Out classes changed 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

    Measured: up to 21 weeks

Secondary outcomes (11)
  1. Inventory of Family Feelings Score

    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.

    Measured: Baseline (pre-test), 9 weeks (post-test)

  2. Coparenting Relationship Scale Score: Undermining Subscale

    The Undermining subscale of the Coparenting Relationship Scale contains 3-items, scored on a scale of 1=strongly disagree to 5=strongly agree. Change in summed score will be reported (between 3-15) with lower scores indicative of a stronger coparenting relationship.

    Measured: Baseline (pre-test), 9 weeks (post-test)

  3. Coparenting Relationship Scale Score: Alliance Subscale

    The Alliance subscale of the Coparenting Relationship Scale contains 5-items, scored on a scale of 1=strongly disagree to 5=strongly agree. Change in summed score will be reported (between 5-25) with higher scores indicative of a stronger coparenting relationship.

    Measured: Baseline (pre-test), 9 weeks (post-test)

  4. Coparenting Relationship Scale Score: Gatekeeping Subscale

    The Gatekeeping subscale of the Coparenting Relationship Scale contains 3 items, scored on a scale of 1=strongly disagree to 5=strongly agree. Change in summed score will be reported (between 3-15) with lower scores are indicative of a stronger coparenting relationship.

    Measured: Baseline (pre-test), 9 weeks (post-test)

  5. Kansas Parenting Satisfaction Scale Score

    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 summed score will be reported (between 3-21) with higher scores indicative of higher levels of parenting satisfaction.

    Measured: Baseline (pre-test), 9 weeks (post-test)

  6. Parenting Sense of Competence Scale Score

    Parenting competence assessed with the 17-item Parenting Sense of Competence Scale. Items are scored on a scale of 1=strongly disagree to 6=strongly agree. Scores range from 17-102, with higher scores indicative of a stronger sense of competence, satisfaction and efficacy.

    Measured: Baseline (pre-test), 9 weeks (post-test)

  7. Alliance Measure Score

    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 summed score will be reported (between 20-100), with higher scores reflecting stronger coparenting alliances between people.

    Measured: Baseline (pre-test), 9 weeks (post-test)

  8. Child-Parent Relationship Scale (CPRS) Score: Conflict Subscale

    Assessed with the 15-item Child-Parent Relationship Scale-Short Form to assess perceptions of participants' relationship with their children. The Conflict subscale contains 8-items, scored on a scale of 1=definitely does not apply to 5=definitely applies. Change in summed scores (between 8 and 40) for each subscale over time will be reported, higher scores on each subscale (closeness, conflict) indicative of higher levels of each dimension.

    Measured: Baseline (pre-test), 9 weeks (post-test)

  9. Child-Parent Relationship Scale (CPRS) Score: Closeness Subscale

    Assessed with the 15-item Child-Parent Relationship Scale-Short Form to assess perceptions of participants' relationship with their children. The Closeness subscale contains 7-items, scored on a scale of 1=definitely does not apply to 5=definitely applies. Change in summed scores (between 7 and 35) for each subscale over time will be reported, higher scores on each subscale (closeness, conflict) indicative of higher levels of each dimension.

    Measured: Baseline (pre-test), 9 weeks (post-test)

  10. Cohen Perceived Stress Scale Score

    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 summed score (between 0-40) will be reported, with higher scores reflecting higher levels of stress experienced by the participant.

    Measured: Baseline (pre-test), 9 weeks (post-test)

  11. Center for Epidemiologic Studies Depression (CESD) Depression Scale Score

    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 summed score (between 0-60) will be reported, with higher scores indicating the presence of more depression symptomology.

    Measured: Baseline (pre-test), 9 weeks (post-test)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2020
  2. Study start16 Sep 2020
  3. Primary completion31 Mar 2022
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04525703
Sponsor's protocol ID
2020-0144
Other IDs
A488200, L&S/SOCIAL WORK/SOC WORK, 4R00HD081273-03, Protocol Version 7/8/2021
Status last verified
Jun 2023
First submitted
20 Aug 2020
Last updated
7 Jul 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pathways for Parents after Incarceration in people with Parenting and Development, Child, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Eligible Fathers and Caregivers Who Consent (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.

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