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临床试验/NCT04441307
NCT04441307已完成不适用

Strong Foundations: Intervening to Promote Co-Parenting and Reduce Father Hazardous Drinking in Expectant Parents

Penn State University2 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2021年1月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
368
试验地点
2
主要终点
Parent Adjustment

研究概览

简要总结

This study aims to understand if a parenting program that helps couples learn to parent as a team and maintain a healthy lifestyle, such as maintaining safer levels of alcohol use, promotes parent and child health and well-being. Programs will be delivered prenatally and postnatally and will include both group classes and individualized sessions. A comprehensive assessment is administered during pregnancy and then at 6 and 12 months of child age. It is hypothesized that targeting intervention during the naturally motivating transition to parenthood may not only provide opportunities for long lasting behavioral change for parents, but also initiate a cascade of protective processes that ultimately reduce risk for negative emotional and behavioral outcomes for children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will be asked to participate in a parenting program but will not be informed about which arm of the study they have been assigned. To avoid bias in the evaluation of the interventions, outcome assessors will not be informed about which arm of the study participants have been assigned.

入排标准

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

入选标准

  • •Pregnant couples who are cohabitating
  • •Parents are 18 years of age or older
  • •Health behavior such as moderate to heavy drinking
  • •English speaking

排除标准

  • •Plural pregnancy
  • •Illicit drug use other than cannabis during pregnancy

研究组 & 干预措施

Healthy Foundations

Active Comparator

A community-based parenting education program with individual family check ins will be implemented to all participants assigned to this arm.

干预措施: Healthy Foundations (Behavioral)

Family Foundations

Experimental

An adapted Family Foundations parenting program for expecting first time parents with individual family check ins will be implemented to all participants assigned to this arm.

干预措施: Family Foundations (Behavioral)

结局指标

主要结局

Parent Adjustment

时间窗: 6 months of child age

Parent adjustment will be assessed with self-report on mental health screenings. The Brief Symptom Inventory is a widely used mental health screening measure. Average responses to the listed symptoms range from 0 (not at all) to 4 (extremely) based on how distressing symptoms have been. Higher scores indicate greater intensity of symptoms.

Parent Alcohol Use

时间窗: 6 months of child age

Quantity-frequency of alcohol use (Quantity Frequency Index) and frequency of binge drinking (4 or 5 or more on a single occasion) based on the NIAAA standard drink will be assessed. Higher scores indicate greater quantity and frequency of alcohol use and binge drinking, with moderate drinking being defined as up to 1 standard drink per day for women and up to 2 standard drinks per day for men.

Couple Relationship/Co-parenting

时间窗: 6 months of child age

Couple relationship will be evaluated through the Co-parenting Relationship Scale. For overall coparenting quality, average responses range from 0 (not true of us/never) to 6 (very true of us/very often). Lower scores indicate worse outcomes.

次要结局

  • Parent-infant Interactions(6 and 12 months of child age)
  • Infant Self-Regulation(6 and 12 months of child age)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rina D. Eiden

Professor of Psychology

Penn State University

研究点 (2)

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