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Completed

NCT Number: NCT03194672

Healthy Adolescent Transitions (HAT)

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.

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Key information

Conditions

Pregnancy Prevention Life Skill Development

Age range

14 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

OhioHealth Innovation Institute

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(at baseline)

  • Age 14-19 years
  • 24-35 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Long acting reversible contraception

    Time frame: 12 months post enrollment

    Use of long acting reversible contraception

  2. Repeat pregnancy

    Time frame: 21 months post enrollment

    Repeat pregnancy

Secondary outcomes

  1. Nicotine use

    Time frame: 21 months post enrollment

    Use of cigarettes and vapor products

  2. Financial literacy

    Time frame: 21 months post enrollment

    Understanding of financial terminology

  3. School completion

    Time frame: 21 months post enrollment

    Highest grade completed

  4. Medical home

    Time frame: 21 months post enrollment

    Use of primary care services

  5. Healthy eating behaviors

    Time frame: 21 months post enrollment

    Eating nutritional food according to items from Youth Risk Behavior Survey

  6. Employment

    Time frame: 21 months post enrollment

    Number of hours worked per week

Sponsors and collaborators

Lead sponsor

Jack Stevens

Other

Collaborators

  • OhioHealth Research and Innovation Institute

Registry information

Official study title

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

Acronym: HAT

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2017
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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