Healthy Adolescent Transitions (HAT) (HAT)

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Prevention; Life Skill Development
• Intervention / Treatment: Behavioral: Healthy Adolescent Transitions (HAT) program

• Study Type: Interventional
• Enrollment (Actual): 331
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • OhioHealth Innovation Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Condition; 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; 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.
No Intervention: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jack Stevens
• Collaborators: OhioHealth Research and Innovation Institute
• Investigators: Principal Investigator: Jack Stevens, PhD, Nationwide Children's Hospital

Publications and helpful links

General Publications

• 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 Mar 2. doi: 10.1007/s11121-024-01660-3. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): March 2, 2024
• Study Completion (Actual): March 2, 2024

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 90AP2678-01-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: de-identified data base will be available at conclusion of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No