New at Parenting Study

Not Applicable

Completed

• Conditions: Control Group; Counseling

• Registration Number: NCT07076381
• Lead Sponsor: University of San Francisco

Brief Summary

This study examines whether a brief counseling intervention provided to parents virtually in the first six months after having their baby is able to reduce and prevent the development of depression symptoms, anxiety, and stress. It also explores whether parents' confidence increases over time and whether they feel more support by the end of the intervention. The study will compare a group of parents who receive the intervention from trained graduate students in clinical psychology with a group of parents who do not receive the intervention.

Select parents will also be interviewed to understand their experiences of new parenting and to help explain the research findings of the study.

Detailed Description

The primary purpose of this pilot study is to examine the impact of receiving regularly scheduled phone counseling services delivered by advanced, trained clinical psychology doctoral students during the first six months of parenthood, for low-risk first-time parents. This study will examine whether parents who receive scheduled phone counseling services delivered through brief therapy techniques demonstrate a greater change from pregnancy to six months postpartum in their anxiety symptoms, depressive symptoms, self-efficacy/parenting confidence, stress, and social support when compared to a matched control group of parents who do not receive regularly scheduled phone calls.

A secondary purpose of this study is to qualitatively explore the experience of parents who undergo the initial transition to parenthood; that is, what are the common themes requiring support that emerge with respect to the transition to parenthood? Additionally, the study aims to identify the acceptability and utility of using a phone-based counseling service for new parents and to elicit feedback about potential modifications that can be made to increase the positive impact of the service in the future.

Study Timeline

• Study Start: 2018-01-04
• Primary Completion: 2018-12-30
• Study Completion: 2020-03-30
• Status Verified: 2025-07
• Study First Submitted: 2025-07-14
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Biological parent who is (or has a partner who is) between 27 and 39 weeks pregnant with first child OR a parent who is planning to adopt a newborn child within the timeline of the study;
• Parent does not have current psychiatric history/hospitalizations;
• Parent has a reliable phone and/or computer connection that will enable them to receive calls from Parentline team member and complete online questionnaires

Exclusion Criteria

Participants who do not meet the inclusion criteria will not be eligible for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postpartum Specific Anxiety Scale	At 1 month and 6 months postpartum	This 51-item self-report scale is designed to examine the frequency, and not severity, of anxieties specific to the postpartum period. The PSAS is not a diagnostic tool, nor is it to be used for screening purposes, at present. The PSAS was developed and validated for use with mothers of infants aged between 0 and 6 months. The PSAS includes items about emotional distress, and anxieties related to the participant's newborn infant.
Edinburgh Postnatal Depression Scale	At enrollment, 1 month postpartum, and 6 months postpartum	The EPDS assesses depressive symptoms in the past week using a 4-point likert scale. Total scores range from 0 to 30 and a cutoff score of 10 or 13 is commonly used to indicate possible depression.
Perceived Stress Scale - Short Form	At enrollment, 1 month postpartum, and 6 months postpartum	The PSS is a 10-item measure commonly used to measure the degree of "how unpredictable, uncontrollable, and overloaded respondents find their lives."
Karitane Parenting Confidence Scale	At 1 month postpartum and 6 months postpartum	The scale measures self-efficacy among parents of infants 0 through 12 months of age. Respondents answer 15 items on a 4-point likert scale; a score of 39 or less is indicative of low levels of parenting confidence.
Multidimensional Scale of Perceived Social Support	At enrollment, 1 month postpartum, and 6 months postpartum	The Multidimensional Scale of Perceived Social Support is a measure of how much support a parent feels they get from family, friends and significant others.
State-Trait Anxiety Inventory - Short Form	At enrollment	This is a 6-item measure of how participants are feeling in the moment.

Secondary Outcome Measures

Name	Time	Method
Brief Infant Sleep Questionnaire	At 6 months postpartum	This is a screening tool that can be used to identify sleep concerns in infants.

Trial Locations

Locations (1)

University of San Francisco; 🇺🇸 San Francisco, California, United States