An interventional study of Behavioral Treatment in Perinatal Mental Health, sponsored by University of Colorado, Denver. Recruiting at 2 sites in United States. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Health services research
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.
University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
anticipatory guidance, brief behavioral intervention, or referral to community mental health provider
Behavioral: Behavioral Treatment
usual care
anticipatory guidance, brief behavioral intervention, or referral to community mental health provider
Mental health self-efficacy scale
Mental health self-efficacy
Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
City Mental Illness Stigma Scale
Mental illness stigma
Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Parenting Sense of Self Confidence Scale
Parenting self-efficacy
Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Edinburgh Postnatal Depression Scale (EDPS)
Perinatal depression
Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
GAD-7
Anxiety
Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Post-Traumatic Stress Disorder Questionnaire (PPQ)
PTSD
Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
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University of Colorado, Denver