Adolescents Clinical Trial
— YPPProConOfficial title:
Young Parents Program, Project Connect
Verified date | July 2020 |
Source | Boston Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hosptial | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital | Department of Health and Human Services |
United States,
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
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 |
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