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Completed

NCT Number: NCT01888809

Building Healthy Children

This study will evaluate the effectiveness of providing a combination of evidence-based behavioral health treatments for mothers who gave birth to their first child prior to the age of 21 and who meet eligibility requirements and their children on prevention of child maltreatment and promotion of positive socioemotional development.

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Key information

Conditions

Age range

12 year–23 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mt. Hope Family Center

Rochester, New York, 14608, United States

About this study

Building Healthy Children is a collaboration of social service and health care agencies, each providing evidence-based services to intervention families in a seamless package. Low-income parents who gave birth to their first child when they were under 21 and who were not involved in the child welfare system were targeted as an at-risk group for whom home visitation services would offer optimal preventive and cost-efficiency outcomes. Services include Interpersonal Psychotherapy [IPT] for maternal depression and Child Parent Psychotherapy [CPP] for maternal-child relationship development and trauma treatment, and Parents As Teachers [PAT]. Families are provided a tiered complement of BHC services based upon risk and current need.

Case management and outreach services are key to assure family engagement and full program participation. An assigned community outreach worker provides a consistent, nurturing relationship that helps retain families in the program and readies parents for the evidence-based treatments, movement towards goals, and behavior change. Outreach workers help to stabilize families and ensure compliance with medical appointments and recommended care.

Most importantly, BHC home-based services are integrated with primary care practices: pediatric, family medicine, and federally qualified neighborhood health center. These comprehensive services are compared with a screening and referral only group in a randomized design. Integration with the child's medical home is an all-inclusive approach to improve child health and well-being and to achieve desired program outcomes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants will include patients drawn from Strong Pediatrics, Anthony Jordan Health Center, Rochester General Hospital, or Highland Family Medicine
  • residents of Monroe County,
  • Temporary Assistance for Needy Families (TANF) eligible,
  • are neither currently active nor have had an indicated CPS report,
  • have a mother who is or was under 21 at the birth of her first child, and
  • has a maximum of two children under the age of three.

Exclusion criteria

  • Children who have indicated Child Protective reports or who are in foster care at the time of recruitment
  • Any children or mothers who are not able to complete the research protocol also will be excluded.
  • Potential subjects suffering from extreme medical or psychiatric conditions (such as severe brain injury or psychosis) or serious cognitive impairments (such as mental retardation) that would render them incapable of completing research measures validly will be excluded.
  • Mothers with thought disorder, severe depression or suicidality requiring hospitalization, severely limited intellectual functioning (IQ less than 70), and current maternal incarceration.

Treatment and study plan

Comprehensive preventive services

Behavioral

Combined evidence-based services:Parents as Teachers Home visitation, Child-Parent Psychotherapy, and/or Interpersonal Psychotherapy with outreach support

Other names: Parents as Teachers Home visitation, Child-Parent Psychotherapy, Interpersonal Psychotherapy, Outreach support

Screening and Referral

Behavioral

Primary outcomes

  1. Prevention of indicated Child Protective Services (CPS) reports, including change over time

    Time frame: Baseline and child's age of 12, 24, 36, 48, and 60 months

    Prevention of indicated Child Protective Services (CPS) reports on mothers and their children

Secondary outcomes

  1. Reduction in family risks over time

    Time frame: Baseline and child's age of 12, 24, 36, 48, and 60 months

    Changes in family risks, including maternal depression, domestic violence exposure, health outcomes, and family stability

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Monroe County Department of Human Services
  • United Way of Greater Rochester

Registry information

Official study title

Building Health Children: Randomized Controlled Trial (RCT) Evaluation

Acronym: BHC

Important dates

Study start
2007
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2013
Registry last updated
Mar 19, 2020

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.