- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03887910
Northwell Health Visits: A Family Connects Pilot Implementation at Northwell Health
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Manhasset, New York, United States, 11030-3802
- Northwell Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Infant Born at Katz Women's Hospital at Long Island Jewish (LIJ) Medical Center
- Mother Age 18 years or older
- Mother who has delivered a single live born normal infant, vaginally or by cesarean section
- Mother Primary Language Spoken is English
Exclusion Criteria:
- Loss of Pregnancy
- Fetal demise
- No health insurance
- Infant in neonatal intensive care unit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enhanced Intervention
Northwell Health Visits postnatal Nurse Practitioner home visitation program and referrals and developmental toys.
|
Participants randomized to the Enhanced Intervention group will receive the Family Connects program, an evidence- based structure that begins at the birthing hospital stay, followed by 1 to 3 nurse home visits between 4 to 12 weeks of infant age, a follow-up contact one month later and a discharge home visit six months later and a final follow-up contact one month after that.
During the home visits, the nurse engages with the mother and completes a holistic health and psychosocial assessment, during which the unique risks and family needs across 12 family domains are evaluated and addressed with either referrals with matched community resources or thorough education.
In addition, they will be given a set of six developmental toys.
Other Names:
|
Experimental: Intervention
Northwell Health Visits postnatal Nurse Practitioner home visitation program and developmental screening and parent guides only.
|
Participants randomized to the Intervention group will receive the Family Connects program, an evidence- based structure that begins at the birthing hospital stay, followed by 1 to 3 nurse home visits between 4 to 12 weeks of infant age, a follow-up contact one month later and a discharge home visit six months later and a final follow-up contact one month after that.
During the home visits, the nurse engages with the mother and completes a holistic health and psychosocial assessment, during which the unique risks and family needs across 12 family domains are evaluated.
For each screened domain, the nurse is able to systematically address them, which may result in an immediate intervention; either referrals with matched community resources or thorough education.
Other Names:
|
No Intervention: Control
Usual care with developmental toys.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Emergency Room Presentation Rates
Time Frame: Program enrollment until 24 months of Child Age.
|
As reported in hospital administrative records and reported by parent.
|
Program enrollment until 24 months of Child Age.
|
Mother Emergency Room Presentation Rates
Time Frame: Program enrollment until 24 months postnatal.
|
As reported in hospital administrative records and self report.
|
Program enrollment until 24 months postnatal.
|
Child Hospital Admissions
Time Frame: Program enrollment until 24 months postnatal.
|
As reported in hospital administrative records and reported by parent.
|
Program enrollment until 24 months postnatal.
|
Mother Hospital Admissions
Time Frame: Program enrollment until 24 months postnatal.
|
As reported in hospital administrative records and self report.
|
Program enrollment until 24 months postnatal.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mother Postnatal Well-Care Compliance Rates
Time Frame: Program enrollment until 24 months postnatal.
|
Rates of mother compliance with postnatal well-care, self reported and found on hospital records.
|
Program enrollment until 24 months postnatal.
|
Child Postnatal Well-Care Compliance Rates
Time Frame: Program enrollment until 24 months postnatal.
|
Rates of infant compliance with postnatal well-care health checks as reported by mother and found on hospital records.
|
Program enrollment until 24 months postnatal.
|
Mother Mental Health - Anxiety Rates
Time Frame: Program enrollment until 24 months postnatal.
|
Rates of postpartum anxiety symptoms as reported by mother. Assessed with General Anxiety Disorder-7 (GAD-7). Generalized Anxiety Disorder 7-Item (GAD-7) Scale Over the last 2 weeks, how often have you been bothered by the following problems?
Score each with the following options: Not at all (0) Several days (1) More than half the days (2) Nearly every day (3) Scoring Criteria: Total score (adding all the numbers) provides a possible score from 0-21. GAD-7 Total Score Symptom Range 0-4 Minimal Anxiety 5-9 Mild Anxiety 10-14 Moderate Anxiety 15-21 Severe Anxiety |
Program enrollment until 24 months postnatal.
|
Mother Mental Health - Depression Rates
Time Frame: Program enrollment until 24 months postnatal.
|
Rates of postpartum depression symptoms as reported by mother. Assessed with Edinburgh Postnatal Depression Scale (EPDS). SCORING QUESTIONS 1, 2, & 4 (without an *) Are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. QUESTIONS 3, 510 (marked with an *) Are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Maximum score: 30 Possible Depression: 10 or greater Always look at item 10 (suicidal thoughts) |
Program enrollment until 24 months postnatal.
|
Family Connections to Community Services/Resources
Time Frame: Program enrollment until 7 months postnatal.
|
Rates of family connections to community resources and services as reported by the mother.
|
Program enrollment until 7 months postnatal.
|
Mother parenting behaviors
Time Frame: Program enrollment until 24 months postnatal.
|
Rates of mother positive and negative parenting behaviors as reported by mother.
|
Program enrollment until 24 months postnatal.
|
Mother alcohol and other drug abuse
Time Frame: Program enrollment until 24 months postnatal.
|
Rates of mother alcohol and other drug abuse as reported by mother and assessed using CAGE-AID screening tool. The CAGE questionnaire is used to test for alcohol abuse and dependence in adults. The CAGEAID version of the tool has been adapted to include drug use. Item responses on the CAGE and CAGE-AID are scored 0 or 1, with a higher score indicating alcohol or drug use problems. Each affirmative response earns one point. One point indicates a possible problem. Two points indicate a probable problem. 2/4 or greater = positive CAGE, further evaluation is indicated. |
Program enrollment until 24 months postnatal.
|
Family Violence
Time Frame: Program enrollment until 24 months postnatal.
|
Rates of family violence as assessed using the Conflict Tactics Scale (CTS). Instructions: Please check the answer that best describes your relationship with your partner in the past year? The CTS is scored by adding the midpoints for the response categories chosen by the participant. The midpoints are the same as the response category numbers for Categories 0, 1, and 2. For Category 3 (3-5 times) the midpoint is 4, for Category 4 (6- or more times) it is 8. A score of 0 is negative for family violence,higher scores are indicative of greater physical abuse |
Program enrollment until 24 months postnatal.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Child Abuse
- Maternal Mental Health
- Postpartum Nurse Home Visitation
- Infant Emergency Medical Care Presentations
- Mother Emergency Medical Care Presentations
- Parent-Child Relationship Quality
- Family Connections to Community Resources
- Child Development and Milestone Achievement
- Child Neglect
- Child Well-Care Compliance
- Mother Well-Care Compliance
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0328
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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