Clinical trial NCT01888809: Building Healthy Children
Official title: Building Health Children: Randomized Controlled Trial (RCT) Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teen Parenthood
Keywords: teen parents
early childhood development
home visitation
evidence-based treatment
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Monroe County Department of Human Services
name: United Way of Greater Rochester
First posted: 2013-06-28
Enrollment: 1852
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevention of indicated Child Protective Services (CPS) reports, including change over time
timeFrame: Baseline and child's age of 12, 24, 36, 48, and 60 months
Secondary outcomes:
measure: Reduction in family risks over time
timeFrame: Baseline and child's age of 12, 24, 36, 48, and 60 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mt. Hope Family Center
state: New York
Study officials:
affiliation: University of Rochester
name: Sheree L Toth, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paradis HA, Sandler M, Manly JT, Valentine L. Building healthy children: evidence-based home visitation integrated with pediatric medical homes. Pediatrics. 2013 Nov;132 Suppl 2:S174-9. doi: 10.1542/peds.2013-1021R.