Unspecified Child Maltreatment, SuspectedNCT03887910
Northwell Health Visits: A Family Connects Pilot Implementation at Northwell Health
A study testing Enhanced Intervention and Intervention in people with Unspecified Child Maltreatment, Suspected and Unspecified Child Maltreatment, Confirmed, run by Northwell Health at 1 site in United States.
Trial summary
Northwell Health Visits (NHV) is a three year pilot replication of the evidence-based model, Family Connects, which is a brief universal Nurse Practitioner home visiting program for new mothers and their infants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Unspecified Child Maltreatment, Suspected, Unspecified Child Maltreatment, Confirmed, Postpartum Depression
- What is being tested?
- Enhanced Intervention and Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2019to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Loss of Pregnancy
- Fetal demise
- No health insurance
- Infant in neonatal intensive care unit
Trial locations and contacts
1 site in 1 country.
About this study
Northwell Health Visits (NHV) is a three year pilot replication of the evidence-based model, Family Connects, which is a brief universal Nurse Practitioner home visiting program for new mothers and their infants. We seek to compare outcomes among mothers and infants enrolled in the NHV enhanced intervention arm, those enrolled in the NHV screening-only arm, and those in the control arm. NHV will follow a three- armed randomized control trial design.
Read the detailed description
Northwell Health Visits (NHV) is based on Family Connects (formerly Durham Connects), which is a short-term, universal, inexpensive postnatal nurse home visiting program designed to provide brief parenting intervention and to connect families with community resources based on individualized assessments of family needs. The intervention was found to reduce the number of infant emergency medical care episodes and rates of anxiety in mothers, as well as increase community connection, positive parenting behaviors, participation in higher quality out-of-home child care when implemented in Durham, so we are looking to replicate these outcomes. We are adapting the model to serve the local population that is served by Northwell Health - Katz Women's Hospital at Long Island Jewish (LIJ) Medical Center, to see if increasing services in and around discharge is more useful for mothers and infants, and improves outcomes for infants. The focus is of early intervention (education and support by Nurse Practitioner), and connection to community agencies, in order to: reduce healthcare costs, decrease the rate of mothers and infants Potentially Preventable Emergency Room Visits (PPVs), adhere to well-baby care and mother's postpartum care schedules, improve family functioning, strengthen family partnerships and well-being, reduce necessary reports to child protective services, improve mental and physical health outcomes of mothers and infants within the first six months of life.
- Conditions
- Unspecified Child Maltreatment, Suspected, Unspecified Child Maltreatment, Confirmed, Postpartum Depression
- Being tested
- Enhanced Intervention, Intervention
- Keywords
- 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, Maternal Mental Health, Child Abuse, Child Neglect, Child Well-Care Compliance, Mother Well-Care Compliance
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced InterventionOther
Also called Family Connects Plus 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.
InterventionOther
Also called Family Connects
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Intervention | Experimental | Northwell Health Visits postnatal Nurse Practitioner home visitation program and referrals and developmental toys. Receives: Other: Enhanced Intervention |
| Intervention | Experimental | Northwell Health Visits postnatal Nurse Practitioner home visitation program and developmental screening and parent guides only. Receives: Other: Intervention |
| Control | No intervention | Usual care with developmental toys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Emergency Room Presentation Rates
As reported in hospital administrative records and reported by parent.
Measured: Program enrollment until 24 months of Child Age.
Mother Emergency Room Presentation Rates
As reported in hospital administrative records and self report.
Measured: Program enrollment until 24 months postnatal.
Child Hospital Admissions
As reported in hospital administrative records and reported by parent.
Measured: Program enrollment until 24 months postnatal.
Mother Hospital Admissions
As reported in hospital administrative records and self report.
Measured: Program enrollment until 24 months postnatal.
Secondary outcomes (8)
Mother Postnatal Well-Care Compliance Rates
Rates of mother compliance with postnatal well-care, self reported and found on hospital records.
Measured: Program enrollment until 24 months postnatal.
Child Postnatal Well-Care Compliance Rates
Rates of infant compliance with postnatal well-care health checks as reported by mother and found on hospital records.
Measured: Program enrollment until 24 months postnatal.
Mother Mental Health - Anxiety Rates
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?
- Feeling nervous, anxious, or on edge
- Not being able to stop or control worrying
- Worrying too much about different things
- Trouble relaxing
- Being so restless that it's hard to sit still
- Becoming easily annoyed or irritable
- Feeling afraid as if something awful might happen
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
Measured: Program enrollment until 24 months postnatal.
Mother Mental Health - Depression Rates
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)
Measured: Program enrollment until 24 months postnatal.
Family Connections to Community Services/Resources
Rates of family connections to community resources and services as reported by the mother.
Measured: Program enrollment until 7 months postnatal.
Mother parenting behaviors
Rates of mother positive and negative parenting behaviors as reported by mother.
Measured: Program enrollment until 24 months postnatal.
Mother alcohol and other drug abuse
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.
Measured: Program enrollment until 24 months postnatal.
Family Violence
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
Measured: Program enrollment until 24 months postnatal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start9 Jan 2019
- Primary completion1 Jan 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Child Maltreatment, SuspectedStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887910
- Sponsor's protocol ID
- 18-0328
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2019
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.
PubMed 34286512
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Northwell Health Visits: A Family Connects Pilot Implementation at Northwell Health
- ClinicalTrials.gov ID
- NCT03887910
- Acronym / sponsor ID
- 18-0328
- Conditions
- Unspecified Child Maltreatment, Suspected, Unspecified Child Maltreatment, Confirmed, Postpartum Depression
- Keywords
- 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, Maternal Mental Health, Child Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Northwell Health Visits (NHV) is a three year pilot replication of the evidence-based model, Family Connects, which is a brief universal Nurse Practitioner home visiting program for new mothers and their infants. We seek to compare outcomes among mothers and infants enrolled in the NHV enhanced intervention arm, those enrolled in the NHV screening-only arm, and those in the control arm. NHV will follow a three- armed randomized control trial design.
Detailed description
Northwell Health Visits (NHV) is based on Family Connects (formerly Durham Connects), which is a short-term, universal, inexpensive postnatal nurse home visiting program designed to provide brief parenting intervention and to connect families with community resources based on individualized assessments of family needs. The intervention was found to reduce the number of infant emergency medical care episodes and rates of anxiety in mothers, as well as increase community connection, positive parenting behaviors, participation in higher quality out-of-home child care when implemented in Durham, so we are looking to replicate these outcomes. We are adapting the model to serve the local population that is served by Northwell Health - Katz Women's Hospital at Long Island Jewish (LIJ) Medical Center, to see if increasing services in and around discharge is more useful for mothers and infants, and improves outcomes for infants. The focus is of early intervention (education and support by Nurse Practitioner), and connection to community agencies, in order to: reduce healthcare costs, decrease the rate of mothers and infants Potentially Preventable Emergency Room Visits (PPVs), adhere to well-baby care and mother's postpartum care schedules, improve family functioning, strengthen family partnerships and well-being, reduce necessary reports to child protective services, improve mental and physical health outcomes of mothers and infants within the first six months of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enhanced Intervention | Experimental | Other: Enhanced InterventionNorthwell Health Visits postnatal Nurse Practitioner home visitation program and referrals and developmental toys. |
| Intervention | Experimental | Other: InterventionNorthwell Health Visits postnatal Nurse Practitioner home visitation program and developmental screening and parent guides only. |
| Control | No intervention | –Usual care with developmental toys. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Loss of Pregnancy
- Fetal demise
- No health insurance
- Infant in neonatal intensive care unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced InterventionAlso: Family Connects Plus Developmental ToysParticipants 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 | Enhanced Intervention |
| InterventionAlso: Family ConnectsParticipants 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 | Intervention |
Primary outcome
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.
Mother Emergency Room Presentation Rates
Time frame: Program enrollment until 24 months postnatal.
As reported in hospital administrative records and self report.
Child Hospital Admissions
Time frame: Program enrollment until 24 months postnatal.
As reported in hospital administrative records and reported by parent.
Mother Hospital Admissions
Time frame: Program enrollment until 24 months postnatal.
As reported in hospital administrative records and self report.
8 secondary outcomes
Mother Postnatal Well-Care Compliance Rates
Time frame: Program enrollment until 24 months postnatal.
Child Postnatal Well-Care Compliance Rates
Time frame: Program enrollment until 24 months postnatal.
Mother Mental Health - Anxiety Rates
Time frame: Program enrollment until 24 months postnatal.
Mother Mental Health - Depression Rates
Time frame: Program enrollment until 24 months postnatal.
Family Connections to Community Services/Resources
Time frame: Program enrollment until 7 months postnatal.
Mother parenting behaviors
Time frame: Program enrollment until 24 months postnatal.
Mother alcohol and other drug abuse
Time frame: Program enrollment until 24 months postnatal.
Family Violence
Time frame: Program enrollment until 24 months postnatal.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 34286512Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Intervention and Intervention in people with Unspecified Child Maltreatment, Suspected and Unspecified Child Maltreatment, Confirmed, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Emergency Room Presentation Rates (time frame: Program enrollment until 24 months of Child Age.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03887910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.