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临床试验/NCT04525703
NCT04525703已完成不适用

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

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Proportion of Enrolled Fathers and Caregivers Who Complete Entire Intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

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

结局指标

主要结局

Proportion of Enrolled Fathers and Caregivers Who Complete Entire Intervention

时间窗: 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.

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

时间窗: 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

时间窗: 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

Proportion of Eligible Fathers and Caregivers Who Consent

时间窗: 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.

Acceptability of Intervention Assessed by Providers

时间窗: 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.

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

时间窗: 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.

Self-Perceived Helpfulness of the Program for the Participant

时间窗: 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

Acceptability of Intervention Assessed by Parent Satisfaction

时间窗: 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

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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