← Back to Search

Healthy Adolescent Transitions (HAT) program for Birth Control (HAT Trial)

Phase 2

Waitlist Available

Led By Jack Stevens, PhD

Research Sponsored by Jack Stevens

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 14-19 years

Ability to provide informed consent (18-19 years of age) or minor assent and parental consent (<18 years of age)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 months post enrollment

Awards & highlights

HAT Trial Summary

This trial will test a program to help adolescent mothers prevent another pregnancy. 500 mothers from Ohio will be enrolled, half receiving extra assistance from nurses and social workers and half receiving the standard of care.

Who is the study for?

The HAT trial is for English-speaking adolescent mothers aged 14-19 in central Ohio with Medicaid, who are 24-35 weeks pregnant. They must be able to consent or provide assent with parental consent, willing to engage in surveys and coaching, have a smartphone for the app, and access to cellular/WiFi service.Check my eligibility

What is being tested?

This study tests the Healthy Adolescent Transitions (HAT) program aimed at preventing rapid repeat pregnancies among adolescent mothers. Participants will either receive extra support from nurses and social workers or standard care. The process of assigning groups is random.See study design

What are the potential side effects?

Since this trial involves educational interventions rather than medical treatments, traditional physical side effects are not expected. However, participants may experience stress or emotional discomfort related to lifestyle changes encouraged by the program.

HAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 14 and 19 years old.

Select...

I am legally able to consent to participate, or if under 18, I have parental consent.

HAT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 months post enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 months post enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 months post enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Long acting reversible contraception

Repeat pregnancy

Secondary outcome measures

Employment

Financial literacy

Healthy eating behaviors

+3 more

HAT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ConditionExperimental Treatment1 Intervention

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.

Group II: Treatment as Usual Control ConditionActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Healthy Adolescent Transitions (HAT) program

2017

Completed Phase 2

~340

0 / 2Eligibility criteria met