Anxiety & Depression Association of America

Health and Wellness After Preterm Birth

Purpose

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.

Conditions

Preterm Birth
Health Care Utilization
Tobacco Use
Contraceptive Usage
Depression
Weight, Birth

Eligibility

Eligible Ages: Between 14 Years and 45 Years
Eligible Genders: Female
Accepts Healthy Volunteers: Yes

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 including: low preventive care utilization, tobacco use, obesity, depression or anxiety, history of unmet contraceptive needs, chronic or pregnancy-associated hypertension or diabetes. ) - 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.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental CCAPB (intervention)	Intervention participants will receive an intervention focused on health care navigation and motivational enhancement.	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.
Placebo Comparator Usual Care	Usual care participants will not receive the 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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Children's Hospital of Philadelphia

Study Contact

Emily Gregory, MD, MPH
2154193122
gregorye@chop.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.