Clinical trial NCT01379924: Young Parents Program, Project Connect
Official title: Young Parents Program, Project Connect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescents
18 and Under When Child Was Born for Mothers
25 and Under When Child Was Born for Fathers
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2011-06-23
Enrollment: 140
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 1. Specific Aims

1. To evaluate the effects of life skills/parenting groups that are embedded within a comprehensive multidisciplinary clinic for adolescent parents (the Young Parents Program), using a randomized control design. Specifically, the effect of group participation on the following adolescent parent outcomes will be investigated:

   * Parenting attitudes and skills including empathy, non-violent discipline, role appropriateness and developmentally appropriate expectations.
   * Skills of daily living, social relationships, and work/study at follow-up, as measured by the Ansell-Casey Life Skills Assessment Scale.
   * Depression and perceived social support using the CESD-C and Duke Social Support scale.
   * Repeat pregnancy rates at 12 and 24 months after first delivery.
2. To evaluate the overall Young Parents Program service delivery as required by the Office of Adolescent Pregnancy Programs (project funder) using a cross cutting evaluation of health services utilization, social needs and work/educational outcomes.

Detailed description: The Young Parents Program (YPP), a specialty clinic within Children's Hospital Primary Care Center, provides comprehensive medical care, mental health services, and advocacy to high risk, urban teen parents and their young children through a teen-tot model. YPP serves 152 teenage mothers and their babies annually with a multi-disciplinary team knowledgeable in the medical, social, and developmental issues of adolescence and early childhood. Project Connect is an evaluation of both the medical and social services provided by YPP and a randomized controlled trial of an intensive educational arm of YPP.

YPP serves the population that economically, ethnically, and geographically represents the highest rates of subsequent pregnancies and the greatest risk for poor birth outcomes. The staff of physicians, nurse practitioners, social workers, and nurse consists of experienced professionals work with parents, adolescents, and children. YPP has cooperative relationships with Boston area education and job training sites, Early Intervention Programs, the Massachusetts Department of Revenue, community agencies, mental health services, and teen living programs.

By providing an integrated family based comprehensive medical home and a randomized controlled trial of intensive parenting/life skills training, Project Connect enhances teen parents' connections to child, family, peers, partners, medical care, and mental health. Medical care, home visiting, child/adolescent health services, mental health, and fathers' programming are all linked into a continuous program. Goals of the intensive intervention are to enhance parenting and life skills, help participants optimize family interactions, and build self-efficacy.

Project Connect brings together YPP at Boston Children's Hospital (BCH), Healthy Baby/Healthy Child (HB/HC) nurse home visiting program and Families First, a parenting education agency, to provide a state-of-the art model of care for parenting teens in Boston. The model builds on lessons learned and strengths of each program, adding critical new elements of randomized control trial of parenting/life skills modules, and home visiting. Prenatal services will encourage breast-feeding, and support infant care and parenting. YPP provides a medical home with coordinated, continuous health care services, psychosocial support, parenting/life skills modules and individual services for teen mothers and fathers. Integrated fathers' services emphasize male parenting roles, communication, life skills training, violence prevention and positive youth development.

Eligibility criteria: Inclusion Criteria:

* Must be able to speak and read in English
* Mothers must be 18 or under when baby is born
* Fathers must be 25 or under when baby is born
* Child must be seen in YPP
* Willing to complete computer surveys 6 times over 36 months
* Ability to complete computer assisted data collection

Exclusion Criteria:

* If parent does not have custody of children
* If children are no longer receiving care at YPP

Primary outcomes:
measure: Rapid Repeat Pregnancy
timeFrame: 12 months follow-up
measure: Rapid Repeat Pregnancy
timeFrame: 24 months follow-up
measure: Rapid Repeat Pregnancy
timeFrame: 36 months follow-up
Secondary outcomes:
measure: Maternal Parenting Self-esteem Total Score
timeFrame: 12-month follow-up
measure: Maternal Parenting Self-esteem Total Score
timeFrame: 24-month follow-up
measure: Maternal Parenting Self-esteem Total Score
timeFrame: 36-month follow-up
measure: Parenting Profile - Parent-Child Role Responsibilities
timeFrame: 12-month follow-up
measure: Parenting Profile - Parent-Child Role Responsibilities
timeFrame: 24-month follow-up
measure: Parenting Profile - Parent-Child Role Responsibilities
timeFrame: 36-month follow-up
measure: Life Skills Score
timeFrame: 12-month follow-up
measure: Life Skills Score
timeFrame: 24-month follow-up
measure: Life Skills Score
timeFrame: 36-month follow-up
measure: Depressive Symptoms Score
timeFrame: 12-month follow-up
measure: Depressive Symptoms Score
timeFrame: 24-month follow-up
measure: Depressive Symptoms Score
timeFrame: 36-month follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hosptial
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Joanne Cox, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox JE, Harris SK, Conroy K, Engelhart T, Vyavaharkar A, Federico A, Woods ER. A Parenting and Life Skills Intervention for Teen Mothers: A Randomized Controlled Trial. Pediatrics. 2019 Mar;143(3):e20182303. doi: 10.1542/peds.2018-2303. Epub 2019 Feb 12.