Young Parents Program, Project Connect

NCT01379924 | Completed Results DMC

• 1 other identifier: 5 APHPA002033-10-00
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

1\. Specific Aims

• 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.
• 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Rapid Repeat Pregnancy

  Number and percent with any repeat pregnancy by each follow-up time point.

  12 months follow-up

• Rapid Repeat Pregnancy

  Number and percent with any repeat pregnancy by each follow-up time point.

  24 months follow-up

• Rapid Repeat Pregnancy

  Number and percent with any repeat pregnancy by each follow-up time point.

  36 months follow-up

Secondary Outcomes (12)

• Maternal Parenting Self-esteem Total Score

  12-month follow-up

• Maternal Parenting Self-esteem Total Score

  24-month follow-up

• Maternal Parenting Self-esteem Total Score

  36-month follow-up

• Parenting Profile - Parent-Child Role Responsibilities

  12-month follow-up

• Parenting Profile - Parent-Child Role Responsibilities

  24-month follow-up

Study Arms (2)

Young Parents Program plus Parenting/Life Skills modules

EXPERIMENTAL

In addition to receiving standard medical and social services for young parents and their children, patient takes part in 5 one on one modules during the first year of child's life aimed at educational attainment, budgeting, child development, safety in the home and substance abuse.

Behavioral: Parenting/Life Skills Intervention

Young Parents Program usual care

ACTIVE COMPARATOR

Patients receive regular standard of care without modules.

Other: Teen-tot medical home

Interventions

Parenting/Life Skills Intervention BEHAVIORAL

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.

Young Parents Program plus Parenting/Life Skills modules

Teen-tot medical home OTHER

Medical, mental health, and social services provided to teen parents and their children

Young Parents Program usual care

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Boston Children's Hosptial

Boston, Massachusetts, 02115, United States

Location

Related 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):e20182303. doi: 10.1542/peds.2018-2303. Epub 2019 Feb 12.

  PMID: 30755464 RESULT

Limitations and Caveats

* Outcomes data were based on self-report, but repeat pregnancies were verified by chart review * Engaging and retaining teen mothers in the intervention was challenging, but adherence was similar to other teen parenting programs

Results Point of Contact

• Title: Dr. Joanne Cox
• Organization: Boston Children's Hospital

joanne.cox@childrens.harvard.edu

6173557701

Study Officials

• Joanne Cox, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief, Division of General Pediatrics; Medical Director, Boston Children's Primary Care

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 23, 2011
• Study Start: September 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 13, 2020
• Results First Posted: August 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)