Perinatal Mental HealthNCT06467916
The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition From Hospital to Home
A study testing Behavioral Treatment in people with Perinatal Mental Health, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The objective of this study is to develop and pilot test a telehealth-based mental health screening and engagement program that supports parents as their infants transition home from the NICU. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perinatal Mental Health
- What is being tested?
- Behavioral Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Apr 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- NICU parents: Participants will be parents of currently hospitalized preterm infants from either the OHSU NICU or the UCH NICU. We will include parents of live preterm infants who have been admitted in the NICU for at least 2 weeks. Parents must speak English or Spanish. Parents can be of any age.
- NICU stakeholders: Participants will be stakeholders from either the OHSU NICU or the UCH NICU. Stakeholders will be social workers, mental health providers responsible for providing more intensive mental health support for NICU parents, nurses, neonatologists, and hospital administrators.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Susanne Klawetter, PhD, 303-724-1646, susanne.klawetter@cuanschutz.edu
Sunah S Hwang, MD, PhD, MPH/MSPH, 720-848-0000, sunah.hwang@childrenscolorado.org
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Cindy McEvoy, MD,MCR, 503-494-8122, mcevoyc@ohsu.edu
Susanne Klawetter, PhD, 303-724-1646, susanne.klawetter@cuanschutz.edu
About this study
The objective of this study is to develop and pilot test a telehealth-based mental health screening and engagement program that supports parents as their infants transition home from the NICU. The program will use a stepped-care approach to screen parents for depression, anxiety, and PTSD; provide a brief behavioral intervention to those who screen as having at least a low risk of these conditions; and provide a warm hand-off to community mental health services for those at medium to high risk.
- Conditions
- Perinatal Mental Health
- Being tested
- Behavioral Treatment
- Keywords
- neonatal intensive care unit, perinatal mental health, perinatal depression, perinatal anxiety, posttraumatic stress disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral TreatmentBehavioural
anticipatory guidance, brief behavioral intervention, or referral to community mental health provider
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | anticipatory guidance, brief behavioral intervention, or referral to community mental health provider Receives: Behavioral: Behavioral Treatment |
| Control | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental health self-efficacy scale
Mental health self-efficacy
Measured: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Secondary outcomes (2)
City Mental Illness Stigma Scale
Mental illness stigma
Measured: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Parenting Sense of Self Confidence Scale
Parenting self-efficacy
Measured: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start22 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal Mental HealthStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467916
- Sponsor's protocol ID
- 23-1191
- Other IDs
- K08MH127519
- Status last verified
- Apr 2025
- First submitted
- 14 Jun 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Project data and materials will be administered in accordance with both participating institutional and NIH policies, including the NICH Data Sharing Policy and Implementation Guidance of March 5, 2003. Depending on such policies, materials may be transferred to others under the terms of material transfer agreement. Data, including survey instruments and datasets, will be available approximately one year after study completion. Researchers can contact the research staff to request access to datasets and support for their use. Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with normal scientific practices. The final locked dataset will be stripped of all participant identifiers. This dataset will be available to the nonprofit community for noncommercial uses provided that a data-sharing agreement is reached and that the original creators of the dataset are able to collaborate in all secondary data analysis.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition From Hospital to Home
- ClinicalTrials.gov ID
- NCT06467916
- Acronym / sponsor ID
- 23-1191
- Conditions
- Perinatal Mental Health
- Keywords
- neonatal intensive care unit, perinatal mental health, perinatal depression, perinatal anxiety, posttraumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, National Institute of Mental Health (NIMH)
- Study start
- 22 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 21 Jun 2024 (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.
The objective of this study is to develop and pilot test a telehealth-based mental health screening and engagement program that supports parents as their infants transition home from the NICU. The program will use a stepped-care approach to screen parents for depression, anxiety, and PTSD; provide a brief behavioral intervention to those who screen as having at least a low risk of these conditions; and provide a warm hand-off to community mental health services for those at medium to high risk.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Behavioral Treatmentanticipatory guidance, brief behavioral intervention, or referral to community mental health provider |
| Control | No intervention | –usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- NICU parents: Participants will be parents of currently hospitalized preterm infants from either the OHSU NICU or the UCH NICU. We will include parents of live preterm infants who have been admitted in the NICU for at least 2 weeks. Parents must speak English or Spanish. Parents can be of any age.
- NICU stakeholders: Participants will be stakeholders from either the OHSU NICU or the UCH NICU. Stakeholders will be social workers, mental health providers responsible for providing more intensive mental health support for NICU parents, nurses, neonatologists, and hospital administrators.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Behavioral Treatmentanticipatory guidance, brief behavioral intervention, or referral to community mental health provider | Behavioural | Intervention |
Primary outcome
Mental health self-efficacy scale
Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Mental health self-efficacy
2 secondary outcomes
City Mental Illness Stigma Scale
Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Parenting Sense of Self Confidence Scale
Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: Yes. Project data and materials will be administered in accordance with both participating institutional and NIH policies, including the NICH Data Sharing Policy and Implementation Guidance of March 5, 2003. Depending on such policies, materials may be transferred to others under the terms of material transfer agreement. Data, including survey instruments and datasets, will be available approximately one year after study completion. Researchers can contact the research staff to request access to datasets and support for their use. Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with normal scientific practices. The final locked dataset will be stripped of all participant identifiers. This dataset will be available to the nonprofit community for noncommercial uses provided that a data-sharing agreement is reached and that the original creators of the dataset are able to collaborate in all secondary data analysis.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Treatment in people with Perinatal Mental Health, run by University of Colorado, Denver at 2 sites 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 2 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanne Klawetter, PhD (303-724-1646, susanne.klawetter@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental health self-efficacy scale (time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge). 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 24 Apr 2025.