Promoting Co-Parenting and Reducing Hazardous Drinking in New Families

• ClinicalTrials.gov Identifier: NCT04441307
• Recruitment Status: Recruiting
• First Posted: June 22, 2020
• Last Update Posted: March 17, 2023
• Sponsor: Penn State University
• Collaborators: Rochester Institute of Technology; University at Buffalo; National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Information provided by (Responsible Party): Rina D. Eiden, Penn State University

Tracking Information

• First Submitted Date: June 14, 2020
• First Posted Date: June 22, 2020
• Last Update Posted Date: March 17, 2023
• Actual Study Start Date: January 25, 2021
• Estimated Primary Completion Date: April 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 18, 2020)

• Couple Relationship/Co-parenting [ Time Frame: 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.
• Parent Adjustment [ Time Frame: 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 [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 18, 2020)

• Parent-infant Interactions [ Time Frame: 6 and 12 months of child age ]
  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 [ Time Frame: 6 and 12 months of child age ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes 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.

Primary Purpose: Prevention

Condition

• Parenting
• Parent-Child Relations
• Drinking, Alcohol
• Adjustment

Intervention

• Behavioral: Healthy Foundations
  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.
• Behavioral: Family Foundations
  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.

Study Arms

• Active Comparator: Healthy Foundations
  A community-based parenting education program with individual family check ins will be implemented to all participants assigned to this arm.
  Intervention: Behavioral: Healthy Foundations
• Experimental: Family Foundations
  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: Behavioral: Family Foundations

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 18, 2020): 360
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 30, 2024
• Estimated Primary Completion Date: April 30, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Rina D Eiden; 814-863-7767; rde5106@psu.edu

Contact: Stephanie Godleski; 585-475-2643; saggsh@rit.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04441307
• Other Study ID Numbers: STUDY00003112; 7R01AA027708-02 ( U.S. NIH Grant/Contract ); SITE00000607, ( Other Identifier: Pennsylvania State University - Univ Park Local IRB Study ID )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Rina D. Eiden, Penn State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Penn State University
• Original Study Sponsor: Same as current

Collaborators

• Rochester Institute of Technology
• University at Buffalo
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Rina D Eiden, PhD; Penn State
• Principal Investigator: Stephanie Godleski, PhD; Rochester Institute of Technology

• PRS Account: Penn State University
• Verification Date: March 2023