Healthy Adolescent Transitions (HAT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

331 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-14

Study Completion Date

2024-03-02

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.

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Detailed Description

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Conditions

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Pregnancy Prevention Life Skill Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Condition

This experimental condition has three major components:

1. 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.
2. Transportation assistance for medical home appointments.
3. Electronic Prompts/Reminders to Encourage Completion of Goals.

Group Type EXPERIMENTAL

Healthy Adolescent Transitions (HAT) program

Intervention Type BEHAVIORAL

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.

Treatment as Usual Control Condition

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Healthy Adolescent Transitions (HAT) program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age 14-19 years
2. 24-35 weeks gestation
3. Medicaid insurance
4. Central Ohio resident
5. English speaking
6. Ability to provide informed consent (18-19 years of age) or minor assent and parental consent (\<18 years of age)
7. Willingness to complete study-related surveys and coaching sessions
8. Patient must have her own smartphone, capable of running the study-related mobile application
9. Patient must have regular access to cellular or WiFi service

Exclusion Criteria

1. Patients \< 13 years or \>19 years
2. Non-English speaking
3. \<24 or \>35 weeks of gestation
4. Primary residence is located outside of central Ohio
5. Another adolescent from the household has already been enrolled in the program

Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes