Health TrialsbyHealthPanel

The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition From Hospital to Home

ConditionPerinatal Mental Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Behavioral Treatment

    Behavioral

    anticipatory guidance, brief behavioral intervention, or referral to community mental health provider

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Mental health self-efficacy scale

Mental health self-efficacy

Time frame
~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge

Secondary outcomes

1

City Mental Illness Stigma Scale

Mental illness stigma

Time frame
~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
2

Parenting Sense of Self Confidence Scale

Parenting self-efficacy

Time frame
~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge

Other outcomes

1

Edinburgh Postnatal Depression Scale (EDPS)

Perinatal depression

Time frame
~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
2

GAD-7

Anxiety

Time frame
~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
3

Post-Traumatic Stress Disorder Questionnaire (PPQ)

PTSD

Time frame
~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Oregon Health and Science University

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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