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| ID | Type | Description | Link |
|---|---|---|---|
| K08MH127519 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | anticipatory guidance, brief behavioral intervention, or referral to community mental health provider |
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| Control | No Intervention | usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Treatment | Behavioral | anticipatory guidance, brief behavioral intervention, or referral to community mental health provider |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mental health self-efficacy scale | Mental health self-efficacy | ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| City Mental Illness Stigma Scale | Mental illness stigma | ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge |
| Parenting Sense of Self Confidence Scale | Parenting self-efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| Edinburgh Postnatal Depression Scale (EDPS) | Perinatal depression | ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge |
| GAD-7 | Anxiety |
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susanne Klawetter, PhD | Contact | 303-724-1646 | susanne.klawetter@cuanschutz.edu | |
| Sunah S Hwang, MD, PhD, MPH/MSPH | Contact | 720-848-0000 | sunah.hwang@childrenscolorado.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Recruiting | Aurora | Colorado | 80045 | United States |
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.
All shareable, de-identified scientific data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 3 years after the funding period.
Scientific data will be findable for the research community through PubMed Central. For all publications, a digital object identifier (DOI) will be created. The data DOI will be referenced in the publication to allow the scientific community easy access to the data used in the publication.
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge |
| ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge |
| Post-Traumatic Stress Disorder Questionnaire (PPQ) | PTSD | ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge |
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
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