Healthy Adolescent Transitions (HAT)

NCT03194672 | Completed Phase 2

• 1 other identifier: 90AP2678-01-00
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy Prevention; Life Skill Development

Outcome Measures

Primary Outcomes (2)

• Long acting reversible contraception

  Use of long acting reversible contraception

  12 months post enrollment

• Repeat pregnancy

  Repeat pregnancy

  21 months post enrollment

Secondary Outcomes (6)

• Nicotine use

  21 months post enrollment

• Financial literacy

  21 months post enrollment

• School completion

  21 months post enrollment

• Medical home

  21 months post enrollment

• Healthy eating behaviors

  21 months post enrollment

Study Arms (2)

Intervention Condition

EXPERIMENTAL

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.

Behavioral: Healthy Adolescent Transitions (HAT) program

Treatment as Usual Control Condition

NO 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.

Interventions

Healthy Adolescent Transitions (HAT) program 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.

Intervention Condition

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 14-19 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jack Stevens: lead
• OhioHealth Research and Innovation Institute: collaborator

Study Sites (1)

OhioHealth Innovation Institute

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• Stevens J, Rausch J, Osuagwu N, Lutz R. Efficacy of Behavioral Economic Nudges to Assist Teen Mothers: the Healthy Adolescent Transitions Randomized Controlled Trial. Prev Sci. 2024 Apr;25(3):509-520. doi: 10.1007/s11121-024-01660-3. Epub 2024 Mar 2.

  PMID: 38429618 RESULT

Study Officials

• Jack Stevens, PhD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: August 14, 2017
• Primary Completion: March 2, 2024
• Study Completion: March 2, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)