Clinical trial NCT04525703: Pathways for Parents After Incarceration Feasibility Study
Official title: Intervention Feasibility Study - Fatherhood After Prison: Healthy Children and Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Development, Child
Behavior
Keywords: incarceration
antisocial behavior
family
child development
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-08-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Eligible Fathers and Caregivers Who Consent
timeFrame: baseline
measure: Proportion of Enrolled Fathers and Caregivers Who Complete Entire Intervention
timeFrame: up to 9 weeks
measure: Provider Adherence Measured by the Parenting Inside Out Group Observation Feedback Form Score
timeFrame: up to 9 weeks
measure: Acceptability of Intervention Assessed by Providers
timeFrame: up to 9 weeks
measure: Self-Perceived Helpfulness of the Program for the Participant
timeFrame: up to 21 weeks
measure: Participant-Perceived Helpfulness of the Program for the Participant's Child
timeFrame: up to 21 weeks
measure: Acceptability of Intervention Assessed by Participant Recommendation
timeFrame: up to 21 weeks
measure: Acceptability of Intervention Assessed by Parent Satisfaction
timeFrame: up to 21 weeks
Secondary outcomes:
measure: Inventory of Family Feelings Score
timeFrame: Baseline (pre-test), 9 weeks (post-test)
measure: Coparenting Relationship Scale Score: Undermining Subscale
timeFrame: Baseline (pre-test), 9 weeks (post-test)
measure: Coparenting Relationship Scale Score: Alliance Subscale
timeFrame: Baseline (pre-test), 9 weeks (post-test)
measure: Coparenting Relationship Scale Score: Gatekeeping Subscale
timeFrame: Baseline (pre-test), 9 weeks (post-test)
measure: Kansas Parenting Satisfaction Scale Score
timeFrame: Baseline (pre-test), 9 weeks (post-test)
measure: Parenting Sense of Competence Scale Score
timeFrame: Baseline (pre-test), 9 weeks (post-test)
measure: Alliance Measure Score
timeFrame: Baseline (pre-test), 9 weeks (post-test)
measure: Child-Parent Relationship Scale (CPRS) Score: Conflict Subscale
timeFrame: Baseline (pre-test), 9 weeks (post-test)
measure: Child-Parent Relationship Scale (CPRS) Score: Closeness Subscale
timeFrame: Baseline (pre-test), 9 weeks (post-test)
measure: Cohen Perceived Stress Scale Score
timeFrame: Baseline (pre-test), 9 weeks (post-test)
measure: Center for Epidemiologic Studies Depression (CESD) Depression Scale Score
timeFrame: Baseline (pre-test), 9 weeks (post-test)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Pajarita Charles, PhD
role: PRINCIPAL_INVESTIGATOR
References: