Trial Outcomes & Findings for Young Parents Program, Project Connect (NCT NCT01379924)

NCT ID: NCT01379924

Last Updated: 2020-08-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 140 participants
• Primary outcome timeframe: 12 months follow-up
• Results posted on: 2020-08-13

Participant Flow

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.

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.

Participant milestones

Measure	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.	Young Parents Program Usual Care Patients receive regular standard of care without modules. No intervention
Baseline STARTED	72	68
Baseline COMPLETED	72	68
Baseline NOT COMPLETED	0	0
12-month Assessment STARTED	72	68
12-month Assessment COMPLETED	62	55
12-month Assessment NOT COMPLETED	10	13
24-month Assessment STARTED	62	55
24-month Assessment COMPLETED	55	52
24-month Assessment NOT COMPLETED	7	3
36-month Assessment STARTED	55	52
36-month Assessment COMPLETED	52	48
36-month Assessment NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Young Parents Program, Project Connect

Baseline characteristics by cohort

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=72 Participants 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.	Young Parents Program Usual Care n=68 Participants 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.	Total n=140 Participants Total of all reporting groups
Age, Continuous	17.4 years STANDARD_DEVIATION 1.0 • n=5 Participants	17.3 years STANDARD_DEVIATION 1.2 • n=7 Participants	17.3 years STANDARD_DEVIATION 1.1 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	68 Participants n=7 Participants	140 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latina	39 participants n=5 Participants	44 participants n=7 Participants	83 participants n=5 Participants
Race/Ethnicity, Customized Black non-Hispanic	28 participants n=5 Participants	18 participants n=7 Participants	46 participants n=5 Participants
Race/Ethnicity, Customized Other non-Hispanic	3 participants n=5 Participants	6 participants n=7 Participants	9 participants n=5 Participants
Race/Ethnicity, Customized Not reported	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months follow-up

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

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

Outcome measures

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=62 Participants Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. 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. Family planning is discussed at each session.	Young Parents Program Usual Care n=55 Participants Patients receive regular standard of care without parenting/life skills intervention. No intervention
Rapid Repeat Pregnancy	8 Participants	16 Participants

PRIMARY outcome

Timeframe: 24 months follow-up

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

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

Outcome measures

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=55 Participants Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. 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. Family planning is discussed at each session.	Young Parents Program Usual Care n=52 Participants Patients receive regular standard of care without parenting/life skills intervention. No intervention
Rapid Repeat Pregnancy	17 Participants	24 Participants

PRIMARY outcome

Timeframe: 36 months follow-up

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

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

Outcome measures

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=52 Participants Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. 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. Family planning is discussed at each session.	Young Parents Program Usual Care n=48 Participants Patients receive regular standard of care without parenting/life skills intervention. No intervention
Rapid Repeat Pregnancy	22 Participants	32 Participants

SECONDARY outcome

Timeframe: 12-month follow-up

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

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.

Outcome measures

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=49 Participants Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. 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. Family planning is discussed at each session.	Young Parents Program Usual Care n=60 Participants Patients receive regular standard of care without parenting/life skills intervention. No intervention
Maternal Parenting Self-esteem Total Score	116.2 score on a scale Standard Error 1.8	112.8 score on a scale Standard Error 1.7

SECONDARY outcome

Timeframe: 24-month follow-up

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

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.

Outcome measures

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=58 Participants Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. 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. Family planning is discussed at each session.	Young Parents Program Usual Care n=57 Participants Patients receive regular standard of care without parenting/life skills intervention. No intervention
Maternal Parenting Self-esteem Total Score	112.8 score on a scale Standard Error 1.9	110.4 score on a scale Standard Error 2.4

SECONDARY outcome

Timeframe: 36-month follow-up

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

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.

Outcome measures

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=58 Participants Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. 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. Family planning is discussed at each session.	Young Parents Program Usual Care n=51 Participants Patients receive regular standard of care without parenting/life skills intervention. No intervention
Maternal Parenting Self-esteem Total Score	108.5 score on a scale Standard Error 2.6	99.4 score on a scale Standard Error 3.1

SECONDARY outcome

Timeframe: 12-month follow-up

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

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.

Outcome measures

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=49 Participants Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. 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. Family planning is discussed at each session.	Young Parents Program Usual Care n=60 Participants Patients receive regular standard of care without parenting/life skills intervention. No intervention
Parenting Profile - Parent-Child Role Responsibilities	5.9 score on a scale Standard Error 0.4	5.6 score on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: 24-month follow-up

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

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.

Outcome measures

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=55 Participants Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. 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. Family planning is discussed at each session.	Young Parents Program Usual Care n=52 Participants Patients receive regular standard of care without parenting/life skills intervention. No intervention
Parenting Profile - Parent-Child Role Responsibilities	5.4 score on a scale Standard Error 0.4	4.8 score on a scale Standard Error 0.4

SECONDARY outcome

Timeframe: 36-month follow-up

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

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.

Outcome measures

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=58 Participants Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. 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. Family planning is discussed at each session.	Young Parents Program Usual Care n=51 Participants Patients receive regular standard of care without parenting/life skills intervention. No intervention
Parenting Profile - Parent-Child Role Responsibilities	5.1 score on a scale Standard Error 0.3	3.7 score on a scale Standard Error 0.4

SECONDARY outcome

Timeframe: 12-month follow-up

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

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.

Outcome measures

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=49 Participants Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. 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. Family planning is discussed at each session.	Young Parents Program Usual Care n=60 Participants Patients receive regular standard of care without parenting/life skills intervention. No intervention
Life Skills Score	83.0 score on a scale Standard Error 2.0	81.4 score on a scale Standard Error 2.5

SECONDARY outcome

Timeframe: 24-month follow-up

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

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.

Outcome measures

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=58 Participants Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. 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. Family planning is discussed at each session.	Young Parents Program Usual Care n=57 Participants Patients receive regular standard of care without parenting/life skills intervention. No intervention
Life Skills Score	87.0 score on a scale Standard Error 2.2	83.4 score on a scale Standard Error 2.3

SECONDARY outcome

Timeframe: 36-month follow-up

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

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.

Outcome measures

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=58 Participants Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. 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. Family planning is discussed at each session.	Young Parents Program Usual Care n=51 Participants Patients receive regular standard of care without parenting/life skills intervention. No intervention
Life Skills Score	90.6 score on a scale Standard Error 2.1	87.5 score on a scale Standard Error 2.7

SECONDARY outcome

Timeframe: 12-month follow-up

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

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.

Outcome measures

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=49 Participants Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. 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. Family planning is discussed at each session.	Young Parents Program Usual Care n=60 Participants Patients receive regular standard of care without parenting/life skills intervention. No intervention
Depressive Symptoms Score	21.2 score on a scale Standard Error 1.9	17.6 score on a scale Standard Error 1.7

SECONDARY outcome

Timeframe: 24-month follow-up

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

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.

Outcome measures

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=58 Participants Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. 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. Family planning is discussed at each session.	Young Parents Program Usual Care n=57 Participants Patients receive regular standard of care without parenting/life skills intervention. No intervention
Depressive Symptoms Score	18.0 score on a scale Standard Error 1.6	14.5 score on a scale Standard Error 1.2

SECONDARY outcome

Timeframe: 36-month follow-up

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

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.

Outcome measures

Measure	Young Parents Program Plus Parenting/Life Skills Modules n=58 Participants Intervention Modules were developed using the Ansell-Casey Life Skills Assessment Curriculum and The Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. 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. Family planning is discussed at each session.	Young Parents Program Usual Care n=51 Participants Patients receive regular standard of care without parenting/life skills intervention. No intervention
Depressive Symptoms Score	16.4 score on a scale Standard Error 1.4	17.0 score on a scale Standard Error 1.7

Adverse Events

Non Randomized

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Modules

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joanne Cox

Boston Children's Hospital

Phone: 6173557701

Email: joanne.cox@childrens.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place