Skip to main content
OpenTrials
Completed

NCT Number: NCT07076381

New at Parenting Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Control Group Counseling

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of San Francisco

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

Brief and solutions-therapy intervention

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.

Primary outcomes

  1. Postpartum Specific Anxiety Scale

    Time frame: 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.

  2. Edinburgh Postnatal Depression Scale

    Time frame: 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.

  3. Perceived Stress Scale - Short Form

    Time frame: 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."

  4. Karitane Parenting Confidence Scale

    Time frame: 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.

  5. Multidimensional Scale of Perceived Social Support

    Time frame: 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.

  6. State-Trait Anxiety Inventory - Short Form

    Time frame: At enrollment

    This is a 6-item measure of how participants are feeling in the moment.

Secondary outcomes

  1. Brief Infant Sleep Questionnaire

    Time frame: At 6 months postpartum

    This is a screening tool that can be used to identify sleep concerns in infants.

Sponsors and collaborators

Lead sponsor

University of San Francisco

Other

Registry information

Acronym: NAPS

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.