AdolescentsYPPProConNCT01379924
Young Parents Program, Project Connect
A study testing Parenting/Life Skills Intervention and Teen-tot medical home in people with Adolescents and 18 and Under When Child Was Born for Mothers, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescents, 18 and Under When Child Was Born for Mothers, 25 and Under When Child Was Born for Fathers
- What is being tested?
- Parenting/Life Skills Intervention and Teen-tot medical home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- If parent does not have custody of children
- If children are no longer receiving care at YPP
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hosptial
Boston, Massachusetts, 02115
About this study
- 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:
- 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.
Read the 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.
- Conditions
- Adolescents, 18 and Under When Child Was Born for Mothers, 25 and Under When Child Was Born for Fathers
- Being tested
- Parenting/Life Skills Intervention, Teen-tot medical home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting/Life Skills InterventionBehavioural
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.
Teen-tot medical homeOther
Medical, mental health, and social services provided to teen parents and their children
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Parenting/Life Skills Intervention |
| Young Parents Program usual care | Active comparator | Patients receive regular standard of care without modules. Receives: Other: Teen-tot medical home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid Repeat Pregnancy
Number and percent with any repeat pregnancy by each follow-up time point.
Measured: 12 months follow-up
Rapid Repeat Pregnancy
Number and percent with any repeat pregnancy by each follow-up time point.
Measured: 24 months follow-up
Rapid Repeat Pregnancy
Number and percent with any repeat pregnancy by each follow-up time point.
Measured: 36 months follow-up
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startSep 2007
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdolescentsStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Joanne Cox, Boston Children's Hospital
- Investigators
- Joanne Cox, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379924
- Sponsor's protocol ID
- 5 APHPA002033-10-00
- Acronym
- YPPProCon
- Status last verified
- Jul 2020
- First submitted
- 22 Jun 2011
- Last updated
- 13 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30755464
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Parents Program, Project Connect
- ClinicalTrials.gov ID
- NCT01379924
- Acronym / sponsor ID
- YPPProCon / 5 APHPA002033-10-00
- Conditions
- Adolescents, 18 and Under When Child Was Born for Mothers, 25 and Under When Child Was Born for Fathers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- Sep 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Posted 13 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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:
- 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young Parents Program plus Parenting/Life Skills modules | Experimental | Behavioral: Parenting/Life Skills InterventionIn 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 | Other: Teen-tot medical homePatients receive regular standard of care without modules. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- If parent does not have custody of children
- If children are no longer receiving care at YPP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenting/Life Skills InterventionModules 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. | Behavioural | Young Parents Program plus Parenting/Life Skills modules |
| Teen-tot medical homeMedical, mental health, and social services provided to teen parents and their children | Other | Young Parents Program usual care |
Primary outcome
Rapid Repeat Pregnancy
Time frame: 12 months follow-up
Number and percent with any repeat pregnancy by each follow-up time point.
Rapid Repeat Pregnancy
Time frame: 24 months follow-up
Number and percent with any repeat pregnancy by each follow-up time point.
Rapid Repeat Pregnancy
Time frame: 36 months follow-up
Number and percent with any repeat pregnancy by each follow-up time point.
12 secondary outcomes
Maternal Parenting Self-esteem Total Score
Time frame: 12-month follow-up
Maternal Parenting Self-esteem Total Score
Time frame: 24-month follow-up
Maternal Parenting Self-esteem Total Score
Time frame: 36-month follow-up
Parenting Profile - Parent-Child Role Responsibilities
Time frame: 12-month follow-up
Parenting Profile - Parent-Child Role Responsibilities
Time frame: 24-month follow-up
Parenting Profile - Parent-Child Role Responsibilities
Time frame: 36-month follow-up
Life Skills Score
Time frame: 12-month follow-up
Life Skills Score
Time frame: 24-month follow-up
Life Skills Score
Time frame: 36-month follow-up
Depressive Symptoms Score
Time frame: 12-month follow-up
Depressive Symptoms Score
Time frame: 24-month follow-up
Depressive Symptoms Score
Time frame: 36-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30755464Cox 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Cox, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting/Life Skills Intervention and Teen-tot medical home in people with Adolescents and 18 and Under When Child Was Born for Mothers, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rapid Repeat Pregnancy (time frame: 12 months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01379924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.