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NCT Number: NCT04341376

Prevention of Childhood Maltreatment in Families With Young Children

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Child Maltreatment Child Exposure to Intimate Partner Violence

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

E.P. Bradley Hospital

East Providence, Rhode Island, 02915, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Does not meet all inclusion criteria above

Treatment and study plan

Enhanced First Connections

Behavioral

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.

Primary outcomes

  1. Child Maltreatment Status

    Time frame: 6-months postpartum

    Child protection record review

  2. Child Exposure to Intimate Partner Violence

    Time frame: 6-months postpartum

    Child protection record review

  3. Maternal Report of Intimate Partner Violence

    Time frame: 6-months postpartum

    Maternal report: Conflict Tactics Scales

Secondary outcomes

  1. Family engagement in evidence based home visiting programs

    Time frame: 6-months postpartum

    Home visiting record review

  2. Contextual stress exposure

    Time frame: 6-months postpartum

    Maternal report: Contextual Stress Interview

  3. Maternal depressive symptoms

    Time frame: 6-months postpartum

    Maternal report: Patient Health Questionnaire-9

  4. Maternal anxiety symptoms

    Time frame: 6-months postpartum

    Maternal report: Generalized Anxiety Disorder 7-item scale

  5. Maternal PTSD symptoms

    Time frame: 6-months postpartum

    Maternal report: Short Post-Traumatic Stress Disorder Rating Interview

  6. Maternal alcohol use

    Time frame: 6-months postpartum

    Maternal report: Alcohol Use Disorders Test

  7. Maternal substance use

    Time frame: 6-months postpartum

    Maternal report: Drug Abuse Screening Test

  8. Maternal parenting stress

    Time frame: 6-months postpartum

    Maternal report: Parenting Stress Index

  9. Maternal sensitivity

    Time frame: 6-months postpartum

    Observation of free play interaction coded using Parent Caregiver Involvement Scales and Emotional Availability Scales

  10. Maternal hostility

    Time frame: 6-months postpartum

    Observation of free play interaction coded using Emotional Availability Scales

  11. Maternal non-responsiveness

    Time frame: 6-months postpartum

    Maternal report: Maternal Responsiveness Questionnaire

  12. Home environment

    Time frame: 6-months postpartum

    Home Observation for Measurement of the Environment

  13. Mother-infant relationship

    Time frame: 6-months postpartum

    Maternal report: Postpartum Bonding Questionnaire

Sponsors and collaborators

Lead sponsor

Bradley Hospital

Other

Registry information

Official study title

Embedding Mental Health Consultation Within Prenatal Home Visiting to Prevent Child Maltreatment and Violence Exposure

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2020
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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