New at Parenting Study

NCT07076381 | Completed

• 1 other identifier: 934
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Control Group; Counseling

Keywords

Teletherapy; Brief therapy; Postpartum Intervention

Outcome Measures

Primary Outcomes (6)

• Postpartum Specific Anxiety Scale

  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.

  At 1 month and 6 months postpartum

• Edinburgh Postnatal Depression Scale

  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.

  At enrollment, 1 month postpartum, and 6 months postpartum

• Perceived Stress Scale - Short Form

  The PSS is a 10-item measure commonly used to measure the degree of "how unpredictable, uncontrollable, and overloaded respondents find their lives."

  At enrollment, 1 month postpartum, and 6 months postpartum

• Karitane Parenting Confidence Scale

  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.

  At 1 month postpartum and 6 months postpartum

• Multidimensional Scale of Perceived Social Support

  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.

  At enrollment, 1 month postpartum, and 6 months postpartum

• State-Trait Anxiety Inventory - Short Form

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

  At enrollment

Secondary Outcomes (1)

• Brief Infant Sleep Questionnaire

  At 6 months postpartum

Study Arms (2)

Control Group

NO INTERVENTION

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.

Counseling Group

EXPERIMENTAL

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.

Behavioral: Brief and solutions-therapy intervention

Interventions

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.

Counseling Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of San Francisco: lead

Study Sites (1)

University of San Francisco

San Francisco, California, 94110, United States

Location

Related Links

• Related Info

Study Officials

• Dhara Meghani, PhD

  University of San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 22, 2025
• Study Start: January 4, 2018
• Primary Completion: December 30, 2018
• Study Completion: March 30, 2020
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Start date: July 15, 2025 End date: N/A
• Access Criteria: Other researchers will be able to access a de-identified data set with three time points of data from both groups in the study. They will also have access to the primary outcome measures used in order to see how the data were scored. They can access these materials on Open Science Framework

Locations

US (1)