NCT04525703

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

September 16, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 7, 2023

Completed
Last Updated

July 7, 2023

Status Verified

June 1, 2023

Enrollment Period

1.5 years

First QC Date

August 20, 2020

Results QC Date

March 31, 2023

Last Update Submit

June 15, 2023

Conditions

Keywords

incarcerationantisocial behaviorfamilychild development

Outcome Measures

Primary Outcomes (8)

  • 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.

    baseline

  • 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.

    up to 9 weeks

  • 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.

    up to 9 weeks

  • 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.

    up to 9 weeks

  • 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

    up to 21 weeks

  • 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.

    up to 21 weeks

  • 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

    up to 21 weeks

  • 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

    up to 21 weeks

Secondary Outcomes (11)

  • Inventory of Family Feelings Score

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

  • Coparenting Relationship Scale Score: Undermining Subscale

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

  • Coparenting Relationship Scale Score: Alliance Subscale

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

  • Coparenting Relationship Scale Score: Gatekeeping Subscale

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

  • Kansas Parenting Satisfaction Scale Score

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

  • +6 more secondary outcomes

Study Arms (1)

Pathways for Parents

EXPERIMENTAL
Behavioral: Pathways for Parents after Incarceration

Interventions

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.

Pathways for Parents

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

BehaviorAntisocial Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Results Point of Contact

Title
Pajarita Charles, PhD
Organization
University of Wisconsin - Madison

Study Officials

  • Pajarita Charles, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2020

First Posted

August 25, 2020

Study Start

September 16, 2020

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

July 7, 2023

Results First Posted

July 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations