Young Parents Program, Project Connect

Adolescents Clinical Trial

— YPPProCon  

Official title:

Young Parents Program, Project Connect

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379924
• Other study ID #: 5 APHPA002033-10-00
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Est. completion date: August 2012

Study information

• Verified date: July 2020
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• 18 and Under When Child Was Born for Mothers
• 25 and Under When Child Was Born for Fathers
• Adolescents

Intervention

Behavioral:
• Parenting/Life Skills Intervention
Modules adapted from the Ansell-Casey Life Skills Assessment Curriculum, the Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. Goal is to help teen mothers develop positive parenting skills, decrease repeat pregnancy and acquire skills of daily living. The series of five, one-hour long, structured, one-on-one interactive modules aims to help teens build positive, empathetic relationships with their children, while enhancing self-efficacy and increasing the sense of self- worth for parents and children. Domains addressed include child development/discipline, safety, house/money management, social relationships, career planning, substance abuse and community and interpersonal violence.

Other:
• Teen-tot medical home
Medical, mental health, and social services provided to teen parents and their children

Locations

Country	Name	City	State
United States	Boston Children's Hosptial	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

References & Publications (1)

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). pii: e20182303. doi: 10.1542/peds.2018-2303. Epub 2019 Fe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rapid Repeat Pregnancy	Number and percent with any repeat pregnancy by each follow-up time point.	12 months follow-up
Primary	Rapid Repeat Pregnancy	Number and percent with any repeat pregnancy by each follow-up time point.	24 months follow-up
Primary	Rapid Repeat Pregnancy	Number and percent with any repeat pregnancy by each follow-up time point.	36 months follow-up
Secondary	Maternal Parenting Self-esteem Total Score	Total score from the widely used Maternal Self-Report Inventory (MSRI) (Shea E & Tronick EZ, 1988). The measure is comprised of 26 items with response items "completely false", "mainly false", "uncertain or neither true or false", "mainly true", and "completely true." The item response scale ranged from 1-5, with higher scores indicating higher maternal self-esteem. The total score is a sum of all items, thus the minimum/maximum possible scores are 26-130. Higher scores indicate higher maternal self-esteem.	12-month follow-up
Secondary	Maternal Parenting Self-esteem Total Score	Total score from the widely used Maternal Self-Report Inventory (MSRI) (Shea E & Tronick EZ, 1988). The measure is comprised of 26 items with response items "completely false", "mainly false", "uncertain or neither true or false", "mainly true", and "completely true." The item response scale ranged from 1-5, with higher scores indicating higher maternal self-esteem. The total score is a sum of all items, thus the minimum/maximum possible scores are 26-130. Higher scores indicate higher maternal self-esteem.	24-month follow-up
Secondary	Maternal Parenting Self-esteem Total Score	Total score from the widely used Maternal Self-Report Inventory (MSRI) (Shea E & Tronick EZ, 1988). The measure is comprised of 26 items with response items "completely false", "mainly false", "uncertain or neither true or false", "mainly true", and "completely true." The item response scale ranged from 1-5, with higher scores indicating higher maternal self-esteem. The total score is a sum of all items, thus the minimum/maximum possible scores are 26-130. Higher scores indicate higher maternal self-esteem.	36-month follow-up
Secondary	Parenting Profile - Parent-Child Role Responsibilities	Subscale sten score from the 40-item Adult-Adolescent Parenting Inventory-2 (Bavolek SJ & Keene RG). Min/max score range = 1-10. Higher scores indicate better parenting and lower risk for child maltreatment.	12-month follow-up
Secondary	Parenting Profile - Parent-Child Role Responsibilities	Subscale sten score from the 40-item Adult-Adolescent Parenting Inventory-2 (Bavolek SJ & Keene RG). Min/max score range = 1-10. Higher scores indicate better parenting and lower risk for child maltreatment.	24-month follow-up
Secondary	Parenting Profile - Parent-Child Role Responsibilities	Subscale sten score from the 40-item Adult-Adolescent Parenting Inventory-2 (Bavolek SJ & Keene RG). Min/max score range = 1-10. Higher scores indicate better parenting and lower risk for child maltreatment.	36-month follow-up
Secondary	Life Skills Score	Total raw score on Ansell-Casey Life Skills (ACLS) Assessment assessing skills of daily living, communication, and relationships. Min/max score range = 37-111. Higher scores indicate higher life skills.	12-month follow-up
Secondary	Life Skills Score	Total raw score on Ansell-Casey Life Skills (ACLS) Assessment assessing skills of daily living, communication, and relationships. Min/max score range = 37-111. Higher scores indicate higher life skills.	24-month follow-up
Secondary	Life Skills Score	Total raw score on Ansell-Casey Life Skills (ACLS) Assessment assessing skills of daily living, communication, and relationships. Min/max score range = 37-111. Higher scores indicate higher life skills.	36-month follow-up
Secondary	Depressive Symptoms Score	Total score on the 20-item Centers for Epidemiologic Studies Depression Scale for Children (CES-DC). Min/max score range = 0-60. Higher scores indicate higher depressive symptoms. Scores over 15 indicate significant level of depressive symptoms.	12-month follow-up
Secondary	Depressive Symptoms Score	Total score on the 20-item Centers for Epidemiologic Studies Depression Scale for Children (CES-DC). Min/max score range = 0-60. Higher scores indicate higher depressive symptoms. Scores over 15 indicate significant level of depressive symptoms.	24-month follow-up
Secondary	Depressive Symptoms Score	Total score on the 20-item Centers for Epidemiologic Studies Depression Scale for Children (CES-DC). Min/max score range = 0-60. Higher scores indicate higher depressive symptoms. Scores over 15 indicate significant level of depressive symptoms.	36-month follow-up