Promoting Co-Parenting and Reducing Hazardous Drinking in New Families
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|ClinicalTrials.gov Identifier: NCT04441307|
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : March 17, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Parenting Parent-Child Relations Drinking, Alcohol Adjustment||Behavioral: Healthy Foundations Behavioral: Family Foundations||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|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.|
|Official Title:||Strong Foundations: Intervening to Promote Co-Parenting and Reduce Father Hazardous Drinking in Expectant Parents|
|Actual Study Start Date :||January 25, 2021|
|Estimated Primary Completion Date :||April 30, 2024|
|Estimated Study Completion Date :||April 30, 2024|
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.
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.
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.
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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Pregnant couples who are cohabitating
- Parents are 18 years of age or older
- Health behavior such as moderate to heavy drinking
- English speaking
- Plural pregnancy
- Illicit drug use other than cannabis for either parent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441307
|Contact: Rina D Eidenemail@example.com|
|Contact: Stephanie Godleskifirstname.lastname@example.org|
|United States, New York|
|University at Buffalo||Recruiting|
|Buffalo, New York, United States, 14260|
|Contact: Meghan Leising, M.A 716-887-3317 email@example.com|
|Contact: Craig Colder, PhD 716-645-0190 firstname.lastname@example.org|
|Rochester Institute of Technology||Recruiting|
|Henrietta, New York, United States, 14467|
|Contact: Stephanie Godleski, PhD 585-475-2643 email@example.com|
|Principal Investigator:||Rina D Eiden, PhD||Penn State|
|Principal Investigator:||Stephanie Godleski, PhD||Rochester Institute of Technology|
|Responsible Party:||Rina D. Eiden, Professor of Psychology, Penn State University|
|Other Study ID Numbers:||
7R01AA027708-02 ( U.S. NIH Grant/Contract )
SITE00000607, ( Other Identifier: Pennsylvania State University - Univ Park Local IRB Study ID )
|First Posted:||June 22, 2020 Key Record Dates|
|Last Update Posted:||March 17, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Alcohol and Health