New at Parenting Study

NCT ID: NCT07076381

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-04
• Study Completion Date: 2020-03-30

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.

Conditions

Control Group; Counseling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group

Control group participants will have an assigned counselor for the study duration and can access them at any time. They will not have a defined treatment schedule in the way that counseling group participants do.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Counseling Group

Counseling group participants will receive three brief therapy sessions virtually from the same counselor between 1 and 5 months postpartum. The intervention is adapted from brief and solutions-therapy and operates on single-session therapy principles.

Group Type: EXPERIMENTAL

Brief and solutions-therapy intervention

Intervention Type: BEHAVIORAL

Parents will receive three phone counseling sessions over "Zoom" of 45-60 minutes each from a counselor when their baby is 4-6 weeks old; 10-12 weeks old, and 16-20 weeks old. The date and time of the sessions will be coordinated by phone or e-mail between the parent and their counselor in the week preceding the call. Following their session, parents in this group will receive a brief satisfaction survey over e-mail (Appendix E) that they will be asked to complete within 72 hours.

Interventions

Brief and solutions-therapy intervention

Parents will receive three phone counseling sessions over "Zoom" of 45-60 minutes each from a counselor when their baby is 4-6 weeks old; 10-12 weeks old, and 16-20 weeks old. The date and time of the sessions will be coordinated by phone or e-mail between the parent and their counselor in the week preceding the call. Following their session, parents in this group will receive a brief satisfaction survey over e-mail (Appendix E) that they will be asked to complete within 72 hours.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Dhara Meghani

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dhara Meghani, PhD

Role: PRINCIPAL_INVESTIGATOR

University of San Francisco

Locations

University of San Francisco

San Francisco, California, United States

Countries

United States

Study Documents

Document Type: Individual Participant Data Set

Open Science Framework website for Principal Investigator, which includes public access to de-identified data set

View Document

Related Links

https://doi.org/10.17605/OSF.IO/7STHM

Related Info

Other Identifiers

934

Identifier Type: -

Identifier Source: org_study_id