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Young Parents Program, Project Connect

Young Parents Program, Project Connect

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01379924
Acronym
YPPProCon
Enrollment
140
Registered
2011-06-23
Start date
2007-09-30
Completion date
2012-08-31
Last updated
2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALParenting/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.

OTHERTeen-tot medical home

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

Sponsors

Department of Health and Human Services
CollaboratorFED
Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rapid Repeat Pregnancy12 months follow-upNumber and percent with any repeat pregnancy by each follow-up time point.

Secondary

MeasureTime frameDescription
Maternal Parenting Self-esteem Total Score12-month follow-upTotal 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.
Parenting Profile - Parent-Child Role Responsibilities12-month follow-upSubscale 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.
Life Skills Score12-month follow-upTotal 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.
Depressive Symptoms Score12-month follow-upTotal 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.

Countries

United States

Participant flow

Recruitment details

The study was conducted in a teen-tot program (Young Parents Program) within a pediatric hospital. Eligibility criteria included maternal age \<19 years at delivery and infant age \<12 months old. At the first infant visit, every patient seen was asked to enroll in the study by trained program staff. assignment.

Pre-assignment details

Of 152 eligible patients who received care in the Young Parents Program who were invited to participate in the randomized trial, 12 declined to participate and were never enrolled into the study, but continued to receive care in the program.

Participants by arm

ArmCount
Young Parents Program Plus Parenting/Life Skills Modules
Patient takes part in modules that were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers. The Nurturing Curriculum has been shown in our past program to be associated with increased parenting skills, maternal self-esteem and decreased life hassles. This curriculum is integrated with the Ansell-Casey life skills Curriculum and The Women's Negotiation Project Curriculum to help teen mothers develop the skills and communication needs 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.
72
Young Parents Program Usual Care
Those in the control group receive the YPP standard of care including comprehensive multi-disciplinary team medical and mental health support and toddler educational family forums during year 2. No intervention.
68
Total140

Baseline characteristics

CharacteristicYoung Parents Program Plus Parenting/Life Skills ModulesYoung Parents Program Usual CareTotal
Age, Continuous17.4 years
STANDARD_DEVIATION 1
17.3 years
STANDARD_DEVIATION 1.2
17.3 years
STANDARD_DEVIATION 1.1
Race/Ethnicity, Customized
Black non-Hispanic
28 participants18 participants46 participants
Race/Ethnicity, Customized
Hispanic/Latina
39 participants44 participants83 participants
Race/Ethnicity, Customized
Not reported
2 participants0 participants2 participants
Race/Ethnicity, Customized
Other non-Hispanic
3 participants6 participants9 participants
Sex: Female, Male
Female
72 Participants68 Participants140 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 720 / 68
other
Total, other adverse events
0 / 120 / 720 / 68
serious
Total, serious adverse events
0 / 120 / 720 / 68

Outcome results

Primary

Rapid Repeat Pregnancy

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

Time frame: 12 months follow-up

Population: Participants with pregnancy data available at 12 months follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Young Parents Program Plus Parenting/Life Skills ModulesRapid Repeat Pregnancy8 Participants
Young Parents Program Usual CareRapid Repeat Pregnancy16 Participants
Comparison: Multiple logistic regression modeling used to compute adjusted odds ratios for 12-month follow-up data.p-value: 0.03795% CI: [0.07, 0.92]Regression, Logistic
Primary

Rapid Repeat Pregnancy

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

Time frame: 24 months follow-up

Population: Participants with pregnancy data available at 24 months follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Young Parents Program Plus Parenting/Life Skills ModulesRapid Repeat Pregnancy17 Participants
Young Parents Program Usual CareRapid Repeat Pregnancy24 Participants
p-value: 0.02995% CI: [0.07, 0.86]Regression, Logistic
Primary

Rapid Repeat Pregnancy

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

Time frame: 36 months follow-up

Population: Participants with pregnancy data available at 36 months follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Young Parents Program Plus Parenting/Life Skills ModulesRapid Repeat Pregnancy22 Participants
Young Parents Program Usual CareRapid Repeat Pregnancy32 Participants
p-value: 0.01795% CI: [0.06, 0.75]Regression, Logistic
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.

Time frame: 36-month follow-up

Population: Number that completed the CES-DC at 36-months follow-up.

ArmMeasureValue (MEAN)Dispersion
Young Parents Program Plus Parenting/Life Skills ModulesDepressive Symptoms Score16.4 score on a scaleStandard Error 1.4
Young Parents Program Usual CareDepressive Symptoms Score17.0 score on a scaleStandard Error 1.7
p-value: 0.591Mixed Models Analysis
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.

Time frame: 12-month follow-up

Population: Number that completed the CES-DC at 12-months follow-up.

ArmMeasureValue (MEAN)Dispersion
Young Parents Program Plus Parenting/Life Skills ModulesDepressive Symptoms Score21.2 score on a scaleStandard Error 1.9
Young Parents Program Usual CareDepressive Symptoms Score17.6 score on a scaleStandard Error 1.7
p-value: 0.803Mixed Models Analysis
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.

Time frame: 24-month follow-up

Population: Number that completed the CES-DC at 24-months follow-up.

ArmMeasureValue (MEAN)Dispersion
Young Parents Program Plus Parenting/Life Skills ModulesDepressive Symptoms Score18.0 score on a scaleStandard Error 1.6
Young Parents Program Usual CareDepressive Symptoms Score14.5 score on a scaleStandard Error 1.2
p-value: 0.347Mixed Models Analysis
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.

Time frame: 12-month follow-up

Population: Number that completed the ACLS at 12-months follow-up.

ArmMeasureValue (MEAN)Dispersion
Young Parents Program Plus Parenting/Life Skills ModulesLife Skills Score83.0 score on a scaleStandard Error 2
Young Parents Program Usual CareLife Skills Score81.4 score on a scaleStandard Error 2.5
p-value: 0.354Mixed Models Analysis
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.

Time frame: 36-month follow-up

Population: Number that completed the ACLS at 36-months follow-up.

ArmMeasureValue (MEAN)Dispersion
Young Parents Program Plus Parenting/Life Skills ModulesLife Skills Score90.6 score on a scaleStandard Error 2.1
Young Parents Program Usual CareLife Skills Score87.5 score on a scaleStandard Error 2.7
p-value: 0.205Mixed Models Analysis
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.

Time frame: 24-month follow-up

Population: Number that completed the ACLS at 24-months follow-up.

ArmMeasureValue (MEAN)Dispersion
Young Parents Program Plus Parenting/Life Skills ModulesLife Skills Score87.0 score on a scaleStandard Error 2.2
Young Parents Program Usual CareLife Skills Score83.4 score on a scaleStandard Error 2.3
p-value: 0.121Mixed Models Analysis
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.

Time frame: 36-month follow-up

Population: Number that completed the MSRI at 36 months follow-up

ArmMeasureValue (MEAN)Dispersion
Young Parents Program Plus Parenting/Life Skills ModulesMaternal Parenting Self-esteem Total Score108.5 score on a scaleStandard Error 2.6
Young Parents Program Usual CareMaternal Parenting Self-esteem Total Score99.4 score on a scaleStandard Error 3.1
p-value: 0.011Mixed Models Analysis
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.

Time frame: 12-month follow-up

Population: Number that completed the MSRI at 12 months follow-up.

ArmMeasureValue (MEAN)Dispersion
Young Parents Program Plus Parenting/Life Skills ModulesMaternal Parenting Self-esteem Total Score116.2 score on a scaleStandard Error 1.8
Young Parents Program Usual CareMaternal Parenting Self-esteem Total Score112.8 score on a scaleStandard Error 1.7
p-value: 0.217Mixed Models Analysis
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.

Time frame: 24-month follow-up

Population: Number that completed the MSRI at 24 months follow-up

ArmMeasureValue (MEAN)Dispersion
Young Parents Program Plus Parenting/Life Skills ModulesMaternal Parenting Self-esteem Total Score112.8 score on a scaleStandard Error 1.9
Young Parents Program Usual CareMaternal Parenting Self-esteem Total Score110.4 score on a scaleStandard Error 2.4
p-value: 0.444Mixed Models Analysis
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.

Time frame: 12-month follow-up

Population: Number that completed the AAPI-2 at 12-months follow-up.

ArmMeasureValue (MEAN)Dispersion
Young Parents Program Plus Parenting/Life Skills ModulesParenting Profile - Parent-Child Role Responsibilities5.9 score on a scaleStandard Error 0.4
Young Parents Program Usual CareParenting Profile - Parent-Child Role Responsibilities5.6 score on a scaleStandard Error 0.3
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.

Time frame: 36-month follow-up

Population: Number that completed the AAPI-2 at 36-months follow-up.

ArmMeasureValue (MEAN)Dispersion
Young Parents Program Plus Parenting/Life Skills ModulesParenting Profile - Parent-Child Role Responsibilities5.1 score on a scaleStandard Error 0.3
Young Parents Program Usual CareParenting Profile - Parent-Child Role Responsibilities3.7 score on a scaleStandard Error 0.4
p-value: 0.024Mixed Models Analysis
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.

Time frame: 24-month follow-up

Population: Number that completed the AAPI-2 at 24-months follow-up.

ArmMeasureValue (MEAN)Dispersion
Young Parents Program Plus Parenting/Life Skills ModulesParenting Profile - Parent-Child Role Responsibilities5.4 score on a scaleStandard Error 0.4
Young Parents Program Usual CareParenting Profile - Parent-Child Role Responsibilities4.8 score on a scaleStandard Error 0.4
p-value: 0.758Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026