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Building Healthy Children

Building Health Children: Randomized Controlled Trial (RCT) Evaluation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01888809
Acronym
BHC
Enrollment
1852
Registered
2013-06-28
Start date
2007-08-31
Completion date
2019-08-01
Last updated
2020-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Teen Parenthood

Keywords

teen parents, early childhood development, home visitation, evidence-based treatment

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.

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.

Interventions

BEHAVIORALComprehensive preventive services

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

Sponsors

Monroe County Department of Human Services
CollaboratorUNKNOWN
United Way of Greater Rochester
CollaboratorUNKNOWN
University of Rochester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 23 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Prevention of indicated Child Protective Services (CPS) reports, including change over timeBaseline and child's age of 12, 24, 36, 48, and 60 monthsPrevention of indicated Child Protective Services (CPS) reports on mothers and their children

Secondary

MeasureTime frameDescription
Reduction in family risks over timeBaseline and child's age of 12, 24, 36, 48, and 60 monthsChanges in family risks, including maternal depression, domestic violence exposure, health outcomes, and family stability

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026