Health and Wellness After Preterm Birth

Depression Clinical Trial

Official title:

Health and Wellness After Preterm Birth: Randomized Controlled Trial of Enhanced Support After Preterm Birth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05756634
• Other study ID #: 21-019198
• Secondary ID: K23HD102560
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: August 2023
• Source: Children's Hospital of Philadelphia
• Contact: Emily Gregory, MD, MPH
• Phone: 2154193122
• Email: gregorye[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study continues an adaptation of the behavioral intervention Care Coordination After Preterm Birth (CCAPB). This is a pragmatic pilot randomized controlled feasibility trial of CCAPB with baseline and post-intervention assessments.

Description:

Interventionists will be trained in care coordination strategies and Motivational Interviewing (MI) techniques. Following training, investigators will enroll eligible women from a postpartum unit at a single hospital, or within 4 weeks of birth.The primary outcome of this study is acceptability and feasibility of the intervention and study procedures as measured by the Acceptability of Intervention Measure, participant completion of study data collection, and interventionist completion of planned intervention modules.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: March 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

Inclusion Criteria:

• Female
• Age 14 - 45
• History of preterm birth (< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may include low preventive care utilization,
• tobacco use, obesity, depression or anxiety, or history of unmet contraceptive needs)
• Intention to seek pediatric care at one of two pediatric primary care sites
• Medicaid insurance

Exclusion Criteria:

• History of sterilization procedure.
• Plan to move away from the area or transfer pediatric primary care within six months of enrollment.
• Limited English proficiency.
• History of organ failure or malignancies.

Related Conditions & MeSH terms

• Birth Weight
• Contraceptive Usage
• Depression
• Health Care Utilization
• Premature Birth
• Preterm Birth
• Tobacco Use

Intervention

Behavioral:
• Care Coordination after Preterm Birth (CCAPB)
For participants randomized to CCAPB, the care coordinator will follow a manualized intervention to support care planning, health care access, and wellbeing. Contact with participants will be initiated as soon as possible after enrollment, and will continue until six months after enrollment.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the CCAPB intervention	Investigators will use the Acceptability of Intervention Measure (modified) with a threshold of > 3 indicating acceptability.	up to 6 months
Secondary	Patient reported stress.	Stress will be measured by the validated Perceived Stress Scale (PSS).The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful.Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.	up to 6 months
Secondary	Sleep-related impairment	Sleep-related impairment will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment - Short Form 8a.; The Sleep-Related Impairment instrument is a self-reported tool used to document perceived overall sleep-related impairment (or sleep-wake function) over the past seven days. The PROMIS method of scoring uses responses to each item for each participant. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population.	up to 6 months
Secondary	Depression symptoms	Depression symptoms will be measured by the Edinburgh Postnatal Depression Scale (EPDS). The 10-question Edinburgh Postnatal Depression Scale (EPDS) is used to identify patients at risk for perinatal depression. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.	up to 6 months
Secondary	Autonomous motivation	Autonomous motivation will be measured using the Autonomous Motivation and External Regulation scales of the Treatment Self-Regulation Questionnaire (10 items, range 7 - 70, Cronbach alpha 0.90). This is a self administered questionnaire with a higher score indicating higher emotion regulation strategy.	up to 6 months
Secondary	Completion of recommended postpartum care	Completion of recommended postpartum care will be assessed by patient health record review.	up to 6 months
Secondary	Contraceptive Use	Contraceptive Use will be measured using an item from the self administered PRAMS questionnaire.; Are you or your husband or partner doing anything now to keep from getting pregnant? No / Yes (if Yes proceed to next); What kind of birth control are you or your husband using now to keep from getting pregnant?; PRAMS is an ongoing, site-specific, population-based surveillance system designed to identify groups of women and infants at high risk for health problems, to monitor changes in health status, and to measure progress towards goals in improving the health of mothers and infants.	up to 6 months
Secondary	Tobacco use	Tobacco use will be assessed by asking participants "Have you smoked any cigarettes in the past 30 days?"	up to 1 month
Secondary	Multivitamin use	Multivitamin use will be assessed by asking participants "Are you currently taking a multivitamin?"	up to 6 months
Secondary	Autonomy Support	Autonomy support will be measured with the self regulated short form of the Health Care Climate Questionnaire (6 items, range 6 - 42, Cronbach alpha 0.82). Scores on the short form 6-item version are calculated by averaging the individual item scores. Higher average scores represent a higher level of perceived autonomy support.	up to 6 months