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Promoting Co-Parenting and Reducing Hazardous Drinking in New Families

Primary Purpose

Parenting, Parent-Child Relations, Drinking, Alcohol

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Foundations
Family Foundations
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parenting focused on measuring Parenting, Couple Relationship, Alcohol and Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Plural pregnancy
  • Illicit drug use other than cannabis for either parent

Sites / Locations

  • University at BuffaloRecruiting
  • Rochester Institute of TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy Foundations

Family Foundations

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Couple Relationship/Co-parenting
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.
Parent Adjustment
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
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.

Secondary Outcome Measures

Parent-infant Interactions
Parent-child relations will be measured through the coding of play interaction sessions. Parental warmth, sensitivity, and harshness will be coded during parent-infant interactions. Parents will be asked to spend some time with their infants as they normally would at 6 months. At 12 months, parents will be asked to spend some time with infants as they normally would for the first 5 minutes, and given a series of problem-solving tasks to do with their infants for the next 5 minutes. Warmth (positive affective involvement), sensitivity (e.g., flexibility and contingent responsiveness), and harshness (e.g., intrusive and negative behaviors such as angry/hostile mood and voice, disapproval, and criticism) will be coded based on the global 5-point rating scales of the Early Relational Assessment (Clark, 1999). Higher scores on the rating scales indicate higher frequency of warmth, sensitivity, and harshness.
Infant Self-Regulation
The Revised Infant Behavior Questionnaire (IBQ-R, Gartstein & Rothbart, 2003) will be used to obtain parent reports of infant reactivity/regulation at 6 and 12 months of infant ages. The scale measures three broad dimensions of behavior Surgency/Extraversion, Negative Affectivity, and Orienting/Regulation. The Surgency/Extraversion dimension includes approach, vocal reactivity, high intensity pleasure, smiling and laughter, activity level, and perceptual sensitivity. The Negative Affectivity dimension includes sadness, distress to limitations, fear, and low falling reactivity. The Orienting/Regulation dimension includes low intensity pleasure, cuddliness, duration of orienting, and soothability. Scores range from 1-7 and higher scores on each dimension reflect higher surgency, negative affect, and regulation. Average of maternal and paternal scores on these three broad dimensions will be included as the final outcome measures.

Full Information

First Posted
June 14, 2020
Last Updated
March 16, 2023
Sponsor
Penn State University
Collaborators
Rochester Institute of Technology, University at Buffalo, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04441307
Brief Title
Promoting Co-Parenting and Reducing Hazardous Drinking in New Families
Official Title
Strong Foundations: Intervening to Promote Co-Parenting and Reduce Father Hazardous Drinking in Expectant Parents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
Rochester Institute of Technology, University at Buffalo, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parenting, Parent-Child Relations, Drinking, Alcohol, Adjustment
Keywords
Parenting, Couple Relationship, Alcohol and Health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In both arms, couples will experience a parenting program for expecting first time parents. In one arm, parents will receive an adapted Family Foundations program. In the other arm, parents will receive an empirically supported community parenting program.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Foundations
Arm Type
Active Comparator
Arm Description
A community-based parenting education program with individual family check ins will be implemented to all participants assigned to this arm.
Arm Title
Family Foundations
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Foundations
Intervention Description
Healthy Foundations combines elements of a community-based parent education program with additional information about infant and child development, good parenting practices, parent health behavior, and couple support.
Intervention Type
Behavioral
Intervention Name(s)
Family Foundations
Intervention Description
A modified version of Family Foundations, an evidence-based preventive intervention for couples during the transition to parenthood, will be implemented to address several aspects of parent and family adjustment, including parent health behavior, particularly alcohol use, and couple relationship dynamics, to promote a healthy parenting environment.
Primary Outcome Measure Information:
Title
Couple Relationship/Co-parenting
Description
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.
Time Frame
6 months of child age
Title
Parent Adjustment
Description
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.
Time Frame
6 months of child age
Title
Parent Alcohol Use
Description
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.
Time Frame
6 months of child age
Secondary Outcome Measure Information:
Title
Parent-infant Interactions
Description
Parent-child relations will be measured through the coding of play interaction sessions. Parental warmth, sensitivity, and harshness will be coded during parent-infant interactions. Parents will be asked to spend some time with their infants as they normally would at 6 months. At 12 months, parents will be asked to spend some time with infants as they normally would for the first 5 minutes, and given a series of problem-solving tasks to do with their infants for the next 5 minutes. Warmth (positive affective involvement), sensitivity (e.g., flexibility and contingent responsiveness), and harshness (e.g., intrusive and negative behaviors such as angry/hostile mood and voice, disapproval, and criticism) will be coded based on the global 5-point rating scales of the Early Relational Assessment (Clark, 1999). Higher scores on the rating scales indicate higher frequency of warmth, sensitivity, and harshness.
Time Frame
6 and 12 months of child age
Title
Infant Self-Regulation
Description
The Revised Infant Behavior Questionnaire (IBQ-R, Gartstein & Rothbart, 2003) will be used to obtain parent reports of infant reactivity/regulation at 6 and 12 months of infant ages. The scale measures three broad dimensions of behavior Surgency/Extraversion, Negative Affectivity, and Orienting/Regulation. The Surgency/Extraversion dimension includes approach, vocal reactivity, high intensity pleasure, smiling and laughter, activity level, and perceptual sensitivity. The Negative Affectivity dimension includes sadness, distress to limitations, fear, and low falling reactivity. The Orienting/Regulation dimension includes low intensity pleasure, cuddliness, duration of orienting, and soothability. Scores range from 1-7 and higher scores on each dimension reflect higher surgency, negative affect, and regulation. Average of maternal and paternal scores on these three broad dimensions will be included as the final outcome measures.
Time Frame
6 and 12 months of child age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant couples who are cohabitating Parents are 18 years of age or older Health behavior such as moderate to heavy drinking English speaking Exclusion Criteria: Plural pregnancy Illicit drug use other than cannabis for either parent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rina D Eiden
Phone
814-863-7767
Email
rde5106@psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Godleski
Phone
585-475-2643
Email
saggsh@rit.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rina D Eiden, PhD
Organizational Affiliation
Penn State
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephanie Godleski, PhD
Organizational Affiliation
Rochester Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Leising, M.A
Phone
716-887-3317
Email
mlcasey@buffalo.edu
First Name & Middle Initial & Last Name & Degree
Craig Colder, PhD
Phone
716-645-0190
Email
ccolder@buffalo.edu
Facility Name
Rochester Institute of Technology
City
Henrietta
State/Province
New York
ZIP/Postal Code
14467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Godleski, PhD
Phone
585-475-2643
Email
saggsh@rit.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Promoting Co-Parenting and Reducing Hazardous Drinking in New Families

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