Building Healthy Children

NCT01888809 | Completed

• 1 other identifier: BHC-01
• Study Type: interventional
• Target: 1,852
• Locations: 1 country
• Sites: 1

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.

Conditions

Teen Parenthood

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (1)

• Reduction in family risks over time

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

Study Arms (2)

Comprehensive preventive services

EXPERIMENTAL

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

Behavioral: Comprehensive preventive services

Screening and referral

ACTIVE COMPARATOR

Annual screening and referral for services as needed

Behavioral: Screening and referral

Interventions

Comprehensive preventive services BEHAVIORAL

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

Also known as: Parents as Teachers Home visitation, Child-Parent Psychotherapy, Interpersonal Psychotherapy, Outreach support

Comprehensive preventive services

Screening and referral BEHAVIORAL

Screening and referral

Eligibility Criteria

• Age: 12 Years - 23 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Monroe County Department of Human Services: collaborator
• United Way of Greater Rochester: collaborator

Study Sites (1)

Mt. Hope Family Center

Rochester, New York, 14608, United States

Location

Related Publications (1)

• 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.

  PMID: 24187121 DERIVED

MeSH Terms

Interventions

Interpersonal Psychotherapy; Mass Screening; Referral and Consultation

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Sheree L Toth, Ph.D.

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 21, 2013
• First Posted: June 28, 2013
• Study Start: August 1, 2007
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)