Healthy Adolescent Transitions (HAT)

Study Overview
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Brief Summary
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Randomized trial of a rapid repeat pregnancy prevention program for adolescent mothers. Five hundred adolescent mothers from central Ohio will be enrolled--half will be assigned to an intervention that features nurses and social workers providing extra assistance during late pregnancy and the early postnatal period and half will be assigned to a standard of care intervention. OhioHealth is the lead entity. Nationwide Children's Hospital serves as the local independent evaluator. This federally funded contract is supported by the Family and Youth Services Bureau.

Official Title
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Healthy Adolescent Transitions (HAT): A Comprehensive Approach to Targeting Adolescent Mothers

Conditions
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Pregnancy Prevention, Life Skill Development

Intervention / Treatment
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* Behavioral: Healthy Adolescent Transitions (HAT) program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (at baseline) Age 14-19 years 24-35 weeks gestation Medicaid insurance Central Ohio resident English speaking Ability to provide informed consent (18-19 years of age) or minor assent and parental consent (<18 years of age) Willingness to complete study-related surveys and coaching sessions Patient must have her own smartphone, capable of running the study-related mobile application Patient must have regular access to cellular or WiFi service Exclusion Criteria Patients < 13 years or >19 years Non-English speaking <24 or >35 weeks of gestation Primary residence is located outside of central Ohio Another adolescent from the household has already been enrolled in the program

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Condition<br>This experimental condition has three major components: Individual sessions: Roughly 12 90-minute sessions over 3 months Prenatal sessions covering contraceptive options, including long-acting reversible contraception. Prenatal and postnatal sessions will also cover (a) financial benefits of smoking cessation; (b)financial literacy/budgeting skills based upon selected components of the Money Matters curriculum; (c) establishing concrete steps to reach educational/career goals; (d) healthy eating habits; and (e) importance of HPV vaccinations and getting a medical home. Transportation assistance for medical home appointments. Electronic Prompts/Reminders to Encourage Completion of Goals. | Behavioral: Healthy Adolescent Transitions (HAT) program<br>* The components of the intervention are described in the arm description. The intervention is based upon the theoretical framework of behavioral economics, which suggests that low intensity nudges can help recipients accomplish their own goals. All components of the intervention are voluntary; some participants may wish to discuss all components, while other participants may wish to discuss selected components consistent with their priorities.<br>|
| No Intervention: Treatment as Usual Control Condition<br>The comparison group will be a Usual Care control group. The control group will have access to standard medical and behavior health services as part of routine care. Prior to randomization, each enrolled participant will receive a listing of contact information for organizations offering this routine care. The only interaction the HAT providers will have with control group participants is to have periodic and brief phone conversations in which updated changes in contact information will be collected. The HAT providers will also obtain updated changes in contact information for HAT intervention group participants. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long acting reversible contraception | Use of long acting reversible contraception | 12 months post enrollment | 
| Repeat pregnancy | Repeat pregnancy | 21 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nicotine use | Use of cigarettes and vapor products | 21 months post enrollment | 
| Financial literacy | Understanding of financial terminology | 21 months post enrollment | 
| School completion | Highest grade completed | 21 months post enrollment | 
| Medical home | Use of primary care services | 21 months post enrollment | 
| Healthy eating behaviors | Eating nutritional food according to items from Youth Risk Behavior Survey | 21 months post enrollment | 
| Employment | Number of hours worked per week | 21 months post enrollment |