Child MaltreatmentNCT04341376
Prevention of Childhood Maltreatment in Families With Young Children
A study testing Enhanced First Connections in people with Child Maltreatment and Child Exposure to Intimate Partner Violence, run by Bradley Hospital at 1 site in United States.
Trial summary
This study will examine the efficacy of Enhanced First Connections, which is a short-term perinatal home visiting program that includes infant and early childhood mental health consultation. Mothers with a history of adversity or trauma will be the focus of this research. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Child Maltreatment, Child Exposure to Intimate Partner Violence
- What is being tested?
- Enhanced First Connections
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2021to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women
- Recruited in the second or third trimester of pregnancy
- At least one self-reported experience of adversity or trauma
- English or Spanish speaking
Who cannot join
- Does not meet all inclusion criteria above
Trial locations and contacts
1 site in 1 country.
United States1 site
E.P. Bradley Hospital
East Providence, Rhode Island, 02915
About this study
Official title: Embedding Mental Health Consultation Within Prenatal Home Visiting to Prevent Child Maltreatment and Violence Exposure
This study will examine the efficacy of Enhanced First Connections, which is a short-term perinatal home visiting program that includes infant and early childhood mental health consultation. Mothers with a history of adversity or trauma will be the focus of this research. Hypothesized outcomes of Enhanced First Connections include the prevention of child maltreatment (child abuse and neglect), prevention of child exposure to adult intimate partner violence, increases in family engagement in longer-term evidence based home visiting programs, increases in family engagement in specialized support services to address maternal adversity and trauma, reductions in maternal risk factors, and the promotion of positive parenting and the parent-child relationship.
- Being tested
- Enhanced First Connections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced First ConnectionsBehavioural
Enhanced First Connections is a short-term home visiting program that includes prenatal identification and engagement of women with an adversity or trauma history, and infant and early childhood mental health consultation.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced First Connections | Experimental | Enhanced First Connections is a short-term risk assessment and response home visiting referral program. The goal of Enhanced First Connections is to identify family needs and link families to community resources, including evidence based home visiting models. Enhanced First Connections includes prenatal identification and engagement of women with an adversity or trauma history, and infant and early childhood mental health consultation. Women who enroll in Enhanced First Connections are expected to receive between four and eight home visits before being referred to other community resources. Receives: Behavioral: Enhanced First Connections |
| Treatment as Usual | No intervention | Women who receive Treatment as Usual will follow the usual course of clinical care throughout their pregnancy and into the postpartum period, and will be eligible for the typical array of community services that may be offered to them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Maltreatment Status
Child protection record review
Measured: 6-months postpartum
Child Exposure to Intimate Partner Violence
Child protection record review
Measured: 6-months postpartum
Maternal Report of Intimate Partner Violence
Maternal report: Conflict Tactics Scales
Measured: 6-months postpartum
Secondary outcomes (13)
Family engagement in evidence based home visiting programs
Home visiting record review
Measured: 6-months postpartum
Contextual stress exposure
Maternal report: Contextual Stress Interview
Measured: 6-months postpartum
Maternal depressive symptoms
Maternal report: Patient Health Questionnaire-9
Measured: 6-months postpartum
Maternal anxiety symptoms
Maternal report: Generalized Anxiety Disorder 7-item scale
Measured: 6-months postpartum
Maternal PTSD symptoms
Maternal report: Short Post-Traumatic Stress Disorder Rating Interview
Measured: 6-months postpartum
Maternal alcohol use
Maternal report: Alcohol Use Disorders Test
Measured: 6-months postpartum
Maternal substance use
Maternal report: Drug Abuse Screening Test
Measured: 6-months postpartum
Maternal parenting stress
Maternal report: Parenting Stress Index
Measured: 6-months postpartum
Maternal sensitivity
Observation of free play interaction coded using Parent Caregiver Involvement Scales and Emotional Availability Scales
Measured: 6-months postpartum
Maternal hostility
Observation of free play interaction coded using Emotional Availability Scales
Measured: 6-months postpartum
Maternal non-responsiveness
Maternal report: Maternal Responsiveness Questionnaire
Measured: 6-months postpartum
Home environment
Home Observation for Measurement of the Environment
Measured: 6-months postpartum
Mother-infant relationship
Maternal report: Postpartum Bonding Questionnaire
Measured: 6-months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start22 Jan 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MaltreatmentStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bradley Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie H Parade, PhD, Principal investigator, E.P. Bradley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341376
- Sponsor's protocol ID
- R01CE003103
- Status last verified
- Jan 2025
- First submitted
- 6 Apr 2020
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final datasets generated from questionnaire, interview, and observational assessments will be cleaned and merged using SPSS syntax to generate a final dataset for analysis. A public use de-identified dataset that does not include sensitive or potentially identifiable information will be made available. For datasets that include sensitive or potentially identifiable information, data-use agreements will be put in place with appropriate restrictions prior to the provision of data. To ensure that released data have appropriate documentation, a data dictionary will accompany all de-identified datasets that includes data collection methods, measures and variable construction, and potential limitations of use.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embedding Mental Health Consultation Within Prenatal Home Visiting to Prevent Child Maltreatment and Violence Exposure
- ClinicalTrials.gov ID
- NCT04341376
- Acronym / sponsor ID
- R01CE003103
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bradley HospitalUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 10 Apr 2020 (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.
This study will examine the efficacy of Enhanced First Connections, which is a short-term perinatal home visiting program that includes infant and early childhood mental health consultation. Mothers with a history of adversity or trauma will be the focus of this research. Hypothesized outcomes of Enhanced First Connections include the prevention of child maltreatment (child abuse and neglect), prevention of child exposure to adult intimate partner violence, increases in family engagement in longer-term evidence based home visiting programs, increases in family engagement in specialized support services to address maternal adversity and trauma, reductions in maternal risk factors, and the promotion of positive parenting and the parent-child relationship.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced First Connections | Experimental | Behavioral: Enhanced First ConnectionsEnhanced First Connections is a short-term risk assessment and response home visiting referral program. The goal of Enhanced First Connections is to identify family needs and link families to community resources, including evidence based home visiting models. Enhanced First Connections includes prenatal identification and engagement of women with an adversity or trauma history, and infant and early childhood mental health consultation. Women who enroll in Enhanced First Connections are expected to receive between four and eight home visits before being referred to other community resources. |
| Treatment as Usual | No intervention | –Women who receive Treatment as Usual will follow the usual course of clinical care throughout their pregnancy and into the postpartum period, and will be eligible for the typical array of community services that may be offered to them. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women
- Recruited in the second or third trimester of pregnancy
- At least one self-reported experience of adversity or trauma
- English or Spanish speaking
Key exclusion criteria (1 listed)
- Does not meet all inclusion criteria above
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 First ConnectionsEnhanced First Connections is a short-term home visiting program that includes prenatal identification and engagement of women with an adversity or trauma history, and infant and early childhood mental health consultation. | Behavioural | Enhanced First Connections |
Primary outcome
Child Maltreatment Status
Time frame: 6-months postpartum
Child protection record review
Child Exposure to Intimate Partner Violence
Time frame: 6-months postpartum
Child protection record review
Maternal Report of Intimate Partner Violence
Time frame: 6-months postpartum
Maternal report: Conflict Tactics Scales
13 secondary outcomes
Family engagement in evidence based home visiting programs
Time frame: 6-months postpartum
Contextual stress exposure
Time frame: 6-months postpartum
Maternal depressive symptoms
Time frame: 6-months postpartum
Maternal anxiety symptoms
Time frame: 6-months postpartum
Maternal PTSD symptoms
Time frame: 6-months postpartum
Maternal alcohol use
Time frame: 6-months postpartum
Maternal substance use
Time frame: 6-months postpartum
Maternal parenting stress
Time frame: 6-months postpartum
Maternal sensitivity
Time frame: 6-months postpartum
Maternal hostility
Time frame: 6-months postpartum
Maternal non-responsiveness
Time frame: 6-months postpartum
Home environment
Time frame: 6-months postpartum
Mother-infant relationship
Time frame: 6-months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: Yes. Final datasets generated from questionnaire, interview, and observational assessments will be cleaned and merged using SPSS syntax to generate a final dataset for analysis. A public use de-identified dataset that does not include sensitive or potentially identifiable information will be made available. For datasets that include sensitive or potentially identifiable information, data-use agreements will be put in place with appropriate restrictions prior to the provision of data. To ensure that released data have appropriate documentation, a data dictionary will accompany all de-identified datasets that includes data collection methods, measures and variable construction, and potential limitations of use.
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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.
Stephanie H Parade, PhD principal investigator
E.P. Bradley Hospital
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 First Connections in people with Child Maltreatment and Child Exposure to Intimate Partner Violence, run by Bradley Hospital 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 1 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: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 Maltreatment Status (time frame: 6-months postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2025.