Healthy Adolescent Transitions (HAT)

Jack Stevens

Status and phase: Completed; Phase 2

Conditions: Life Skill Development; Pregnancy Prevention

Treatments: Behavioral: Healthy Adolescent Transitions (HAT) program

Study type: Interventional

Funder types: Other

Identifiers

NCT03194672

90AP2678-01-00

Details and patient eligibility

About

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.

Enrollment: 331 patients

Sex: Female

Ages: 14 to 19 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (at baseline)

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

331 participants in 2 patient groups

Intervention Condition

Experimental group

Description:

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.

Treatment:

Behavioral: Healthy Adolescent Transitions (HAT) program

Treatment as Usual Control Condition

No Intervention group

Description:

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.