Healthy Adolescent Transitions (HAT)

Pregnancy Prevention Clinical Trial

— HAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194672
• Other study ID #: 90AP2678-01-00
• Status: Completed
• Phase: Phase 2
• Start date: August 14, 2017
• Est. completion date: March 2, 2024

Study information

• Verified date: March 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: March 2, 2024
• Est. primary completion date: March 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Life Skill Development
• Pregnancy Prevention

Intervention

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.

Locations

Country	Name	City	State
United States	OhioHealth Innovation Institute	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Jack Stevens	OhioHealth Research and Innovation Institute

Country where clinical trial is conducted

United States, 

References & 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 Mar 2. doi: 10.1007/s11121-024-01660-3. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long acting reversible contraception	Use of long acting reversible contraception	12 months post enrollment
Primary	Repeat pregnancy	Repeat pregnancy	21 months post enrollment
Secondary	Nicotine use	Use of cigarettes and vapor products	21 months post enrollment
Secondary	Financial literacy	Understanding of financial terminology	21 months post enrollment
Secondary	School completion	Highest grade completed	21 months post enrollment
Secondary	Medical home	Use of primary care services	21 months post enrollment
Secondary	Healthy eating behaviors	Eating nutritional food according to items from Youth Risk Behavior Survey	21 months post enrollment
Secondary	Employment	Number of hours worked per week	21 months post enrollment