Control GroupNAPSNCT07076381
New at Parenting Study
A study testing Brief and solutions-therapy intervention in people with Control Group and Counseling, run by University of San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Control Group, Counseling
- What is being tested?
- Brief and solutions-therapy intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2018to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants who do not meet the inclusion criteria will not be eligible for the study.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of San Francisco
San Francisco, California, 94110
About this 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.
Read the 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
- Being tested
- Brief and solutions-therapy intervention
- Keywords
- Teletherapy, Brief therapy, Postpartum Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief and solutions-therapy interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Brief and solutions-therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At enrollment
Secondary outcomes (1)
Brief Infant Sleep Questionnaire
This is a screening tool that can be used to identify sleep concerns in infants.
Measured: At 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start4 Jan 2018
- Primary completion30 Dec 2018
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Control GroupStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhara Meghani, University of San Francisco
- Investigators
- Dhara Meghani, PhD, Principal investigator, University of San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076381
- Sponsor's protocol ID
- 934
- Acronym
- NAPS
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This is a pilot study with a small data set. We will make it available for public use or by request on a public data repository.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New at Parenting Study
- ClinicalTrials.gov ID
- NCT07076381
- Acronym / sponsor ID
- NAPS / 934
- Conditions
- Control Group, Counseling
- Keywords
- Teletherapy, Brief therapy, Postpartum Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of San FranciscoUniversity, hospital or other
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Brief and solutions-therapy interventionCounseling 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Participants who do not meet the inclusion criteria will not be eligible for the study.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief and solutions-therapy interventionParents 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. | Behavioural | Counseling Group |
Primary outcome
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.
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.
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."
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.
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.
State-Trait Anxiety Inventory - Short Form
Time frame: At enrollment
This is a 6-item measure of how participants are feeling in the moment.
1 secondary outcome
Brief Infant Sleep Questionnaire
Time frame: At 6 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. This is a pilot study with a small data set. We will make it available for public use or by request on a public data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhara Meghani, PhD principal investigator
University of San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief and solutions-therapy intervention in people with Control Group and Counseling, run by University of San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Specific Anxiety Scale (time frame: At 1 month and 6 months postpartum). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.