Pathways for Parents After Incarceration Feasibility Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04525703

Enrollment

Registered

2020-08-25

Start date

2020-09-16

Completion date

2022-03-31

Last updated

2023-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Development, Child, Parenting

Keywords

incarceration, antisocial behavior, family, child development

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.

Interventions

BEHAVIORALPathways 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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of Eligible Fathers and Caregivers Who Consent	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	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	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 1-5, higher scores indicate better adherence.
Acceptability of Intervention Assessed by Providers	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	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	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. 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.
Acceptability of Intervention Assessed by Participant Recommendation	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	up to 21 weeks	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

Secondary

Measure	Time frame	Description
Child-Parent Relationship Scale (CPRS) Score: Closeness Subscale	Baseline (pre-test), 9 weeks (post-test)	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.
Inventory of Family Feelings Score	Baseline (pre-test), 9 weeks (post-test)	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.
Center for Epidemiologic Studies Depression (CESD) Depression Scale Score	Baseline (pre-test), 9 weeks (post-test)	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.
Cohen Perceived Stress Scale Score	Baseline (pre-test), 9 weeks (post-test)	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.
Coparenting Relationship Scale Score: Undermining Subscale	Baseline (pre-test), 9 weeks (post-test)	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.
Coparenting Relationship Scale Score: Alliance Subscale	Baseline (pre-test), 9 weeks (post-test)	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.
Coparenting Relationship Scale Score: Gatekeeping Subscale	Baseline (pre-test), 9 weeks (post-test)	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.
Kansas Parenting Satisfaction Scale Score	Baseline (pre-test), 9 weeks (post-test)	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.
Parenting Sense of Competence Scale Score	Baseline (pre-test), 9 weeks (post-test)	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.
Alliance Measure Score	Baseline (pre-test), 9 weeks (post-test)	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.
Child-Parent Relationship Scale (CPRS) Score: Conflict Subscale	Baseline (pre-test), 9 weeks (post-test)	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.

Countries

United States

Participant flow

Recruitment details

The Pathways for Parents after Incarceration Program study was conducted between September 2020 and March 2022 during the COVID-19 pandemic.

Pre-assignment details

51 Fathers were assessed for eligibility, 43 were eligible, 21 consented and started the study.

Participants by arm

Arm	Count
Caregivers 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.	12
Fathers 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.	21
Children 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.	15
Total	48

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	6	15	8

Baseline characteristics

Characteristic	Total	Caregivers	Fathers	Children
Age, Categorical <=18 years	15 Participants	0 Participants	0 Participants	15 Participants
Age, Categorical >=65 years	1 Participants	1 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	32 Participants	11 Participants	21 Participants	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants	3 Participants	3 Participants	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants	9 Participants	18 Participants	11 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants	1 Participants	1 Participants	1 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	24 Participants	6 Participants	12 Participants	6 Participants
Race (NIH/OMB) More than one race	8 Participants	2 Participants	2 Participants	4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	13 Participants	3 Participants	6 Participants	4 Participants
Region of Enrollment United States	48 participants	12 participants	21 participants	15 participants
Sex: Female, Male Female	20 Participants	12 Participants	0 Participants	8 Participants
Sex: Female, Male Male	28 Participants	0 Participants	21 Participants	7 Participants
Time Since Incarceration	8 months STANDARD_DEVIATION 13.94	NA months	8 months STANDARD_DEVIATION 13.94	NA months

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 12	0 / 21	0 / 15
other Total, other adverse events	0 / 12	0 / 21	0 / 15
serious Total, serious adverse events	0 / 12	0 / 21	0 / 15

Outcome results

Primary

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

Time frame: up to 21 weeks

Population: One participant in the Fathers group did not answer the survey item.

Arm	Measure	Value (MEAN)	Dispersion
Fathers	Acceptability of Intervention Assessed by Parent Satisfaction	4.64 score on a scale	Standard Deviation 0.67
Caregivers	Acceptability of Intervention Assessed by Parent Satisfaction	4.57 score on a scale	Standard Deviation 0.53

Primary

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

Time frame: up to 21 weeks

Arm	Measure	Value (MEAN)	Dispersion
Fathers	Acceptability of Intervention Assessed by Participant Recommendation	4.83 score on a scale	Standard Deviation 0.39
Caregivers	Acceptability of Intervention Assessed by Participant Recommendation	5.00 score on a scale	Standard Deviation 0

Primary

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.

Time frame: up to 9 weeks

Population: Providers were not consented to the study, but were surveyed for acceptability of the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Fathers	Acceptability of Intervention Assessed by Providers	8.43 score on a scale	Standard Deviation 0.37

Primary

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.

Time frame: up to 21 weeks

Population: There are missing data from 2 participants in the Fathers group.

Arm	Measure	Value (MEAN)	Dispersion
Fathers	Participant-Perceived Helpfulness of the Program for the Participant's Child	3.90 score on a scale	Standard Deviation 0.57
Caregivers	Participant-Perceived Helpfulness of the Program for the Participant's Child	4.43 score on a scale	Standard Deviation 0.53

Primary

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.

Time frame: baseline

Population: 43 Fathers were eligible, 23 consented and started the study

Arm	Measure	Value (NUMBER)
Fathers	Proportion of Eligible Fathers and Caregivers Who Consent	0.49 proportion of participants
Caregivers	Proportion of Eligible Fathers and Caregivers Who Consent	1.0 proportion of participants

Primary

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.

Time frame: up to 9 weeks

Population: This combined criteria (enrolled AND participated in the first intervention class) changes the baseline N to something smaller (n=16, not n=21)

Arm	Measure	Value (NUMBER)
Fathers	Proportion of Enrolled Fathers and Caregivers Who Complete Entire Intervention	0.75 proportion of participants
Caregivers	Proportion of Enrolled Fathers and Caregivers Who Complete Entire Intervention	0.58 proportion of participants

Primary

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.

Time frame: up to 9 weeks

Population: Team stopped collecting this survey after 3 responses as it was determined to be burdensome for the participant and not useful for the investigation.

Arm	Measure	Group	Value (MEAN)	Dispersion
Fathers	Provider Adherence Measured by the Parenting Inside Out Group Observation Feedback Form Score	Overall Fidelity	4.46 score on a scale	Standard Deviation 0.16
Fathers	Provider Adherence Measured by the Parenting Inside Out Group Observation Feedback Form Score	Curriculum Delivery & Fidelity Subscale	4.57 score on a scale	Standard Deviation 0.14
Fathers	Provider Adherence Measured by the Parenting Inside Out Group Observation Feedback Form Score	Facilitation Skills Subscale	4.55 score on a scale	Standard Deviation 0.04
Fathers	Provider Adherence Measured by the Parenting Inside Out Group Observation Feedback Form Score	Behavior Support and Group Management Subscale	4.86 score on a scale	Standard Deviation 0.14
Fathers	Provider Adherence Measured by the Parenting Inside Out Group Observation Feedback Form Score	Interpersonal Skills Subscale	5.00 score on a scale	Standard Deviation 0
Fathers	Provider Adherence Measured by the Parenting Inside Out Group Observation Feedback Form Score	PIO Specific Skills Subscale	4.17 score on a scale	Standard Deviation 0.32

Primary

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

Time frame: up to 21 weeks

Arm	Measure	Value (MEAN)	Dispersion
Fathers	Self-Perceived Helpfulness of the Program for the Participant	4.67 score on a scale	Standard Deviation 0.65
Caregivers	Self-Perceived Helpfulness of the Program for the Participant	4.71 score on a scale	Standard Deviation 0.49

Secondary

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.