Skip to content

New at Parenting Study

New at Parenting Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07076381
Acronym
NAPS
Enrollment
58
Registered
2025-07-22
Start date
2018-01-04
Completion date
2020-03-30
Last updated
2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Control Group, Counseling

Keywords

Teletherapy, Brief therapy, Postpartum Intervention

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.

Interventions

BEHAVIORALBrief 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.

Sponsors

University of San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Perceived Stress Scale - Short FormAt enrollment, 1 month postpartum, and 6 months postpartumThe PSS is a 10-item measure commonly used to measure the degree of how unpredictable, uncontrollable, and overloaded respondents find their lives.
Postpartum Specific Anxiety ScaleAt 1 month and 6 months postpartumThis 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 ScaleAt enrollment, 1 month postpartum, and 6 months postpartumThe 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.
State-Trait Anxiety Inventory - Short FormAt enrollmentThis is a 6-item measure of how participants are feeling in the moment.
Karitane Parenting Confidence ScaleAt 1 month postpartum and 6 months postpartumThe 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 SupportAt enrollment, 1 month postpartum, and 6 months postpartumThe Multidimensional Scale of Perceived Social Support is a measure of how much support a parent feels they get from family, friends and significant others.

Secondary

MeasureTime frameDescription
Brief Infant Sleep QuestionnaireAt 6 months postpartumThis is a screening tool that can be used to identify sleep concerns in infants.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026