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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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1. Specific Aims
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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Young Parents Program usual care | Active Comparator | Patients receive regular standard of care without modules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Cox, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hosptial | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30755464 | Result | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Young Parents Program Plus Parenting/Life Skills Modules | These modules 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. The nationally recognized Nurturing 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. |
| FG001 | Young Parents Program Usual Care | Patients receive regular standard of care without modules. No intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| 12-month Assessment |
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| 24-month Assessment |
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| 36-month Assessment |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rapid Repeat Pregnancy | Number and percent with any repeat pregnancy by each follow-up time point. | Participants with pregnancy data available at 12 months follow-up | Posted | Count of Participants | Participants | 12 months follow-up |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non Randomized | These are those mothers in the group who choose not to be randomized into the study, or the fathers who participate who are not randomized into the study. No intervention: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joanne Cox | Boston Children's Hospital | 6173557701 | joanne.cox@childrens.harvard.edu |
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| Teen-tot medical home | Other | Medical, mental health, and social services provided to teen parents and their children |
|
| 12-month follow-up |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| OG001 | Young Parents Program Usual Care | Patients receive regular standard of care without parenting/life skills intervention. No intervention |
|
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| Primary | Rapid Repeat Pregnancy | Number and percent with any repeat pregnancy by each follow-up time point. | Participants with pregnancy data available at 24 months follow-up | Posted | Count of Participants | Participants | 24 months follow-up |
|
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| Primary | Rapid Repeat Pregnancy | Number and percent with any repeat pregnancy by each follow-up time point. | Participants with pregnancy data available at 36 months follow-up | Posted | Count of Participants | Participants | 36 months follow-up |
|
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|
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| 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. | Number that completed the MSRI at 12 months follow-up. | Posted | Mean | Standard Error | score on a scale | 12-month follow-up |
|
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|
|
| 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. | Number that completed the MSRI at 24 months follow-up | Posted | Mean | Standard Error | score on a scale | 24-month follow-up |
|
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|
|
| 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. | Number that completed the MSRI at 36 months follow-up | Posted | Mean | Standard Error | score on a scale | 36-month follow-up |
|
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|
|
| 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. | Number that completed the AAPI-2 at 12-months follow-up. | Posted | Mean | Standard Error | score on a scale | 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. | Number that completed the AAPI-2 at 24-months follow-up. | Posted | Mean | Standard Error | score on a scale | 24-month follow-up |
|
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|
|
| 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. | Number that completed the AAPI-2 at 36-months follow-up. | Posted | Mean | Standard Error | score on a scale | 36-month follow-up |
|
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|
|
| 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. | Number that completed the ACLS at 12-months follow-up. | Posted | Mean | Standard Error | score on a scale | 12-month follow-up |
|
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|
|
| 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. | Number that completed the ACLS at 24-months follow-up. | Posted | Mean | Standard Error | score on a scale | 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. | Number that completed the ACLS at 36-months follow-up. | Posted | Mean | Standard Error | score on a scale | 36-month follow-up |
|
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|
|
| 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. | Number that completed the CES-DC at 12-months follow-up. | Posted | Mean | Standard Error | score on a scale | 12-month follow-up |
|
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|
|
| 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. | Number that completed the CES-DC at 24-months follow-up. | Posted | Mean | Standard Error | score on a scale | 24-month follow-up |
|
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|
|
| 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. | Number that completed the CES-DC at 36-months follow-up. | Posted | Mean | Standard Error | score on a scale | 36-month follow-up |
|
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|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Modules | These modules 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. The nationally recognized Nurturing 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. | 0 | 72 | 0 | 72 | 0 | 72 |
| EG002 | Control | Patients receive regular standard of care without modules. No intervention | 0 | 68 | 0 | 68 | 0 | 68 |
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