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Building Healthy Children (BHC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01888809
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : March 19, 2020
Monroe County Department of Human Services
United Way of Greater Rochester
Information provided by (Responsible Party):
Sheree Toth, University of Rochester

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Teen Parenthood Behavioral: Comprehensive preventive services Behavioral: Screening and referral Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1852 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Building Health Children: Randomized Controlled Trial (RCT) Evaluation
Actual Study Start Date : August 2007
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019

Arm Intervention/treatment
Experimental: Comprehensive preventive services
Combined comprehensive services:Parents as Teachers Home visitation, Child-Parent Psychotherapy, and/or Interpersonal Psychotherapy with outreach support
Behavioral: Comprehensive preventive services
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

Active Comparator: Screening and referral
Annual screening and referral for services as needed
Behavioral: Screening and referral

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01888809

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United States, New York
Mt. Hope Family Center
Rochester, New York, United States, 14608
Sponsors and Collaborators
University of Rochester
Monroe County Department of Human Services
United Way of Greater Rochester
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Principal Investigator: Sheree L Toth, Ph.D. University of Rochester
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sheree Toth, Professor, University of Rochester Identifier: NCT01888809    
Other Study ID Numbers: BHC-01
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sheree Toth, University of Rochester:
teen parents
early childhood development
home visitation
evidence-based treatment