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Healthy Adolescent Transitions (HAT) (HAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03194672
Recruitment Status : Active, not recruiting
First Posted : June 21, 2017
Last Update Posted : October 17, 2019
Sponsor:
Collaborator:
OhioHealth Research and Innovation Institute
Information provided by (Responsible Party):
Jack Stevens, Nationwide Children's Hospital

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.


Condition or disease Intervention/treatment Phase
Pregnancy Prevention Life Skill Development Behavioral: Healthy Adolescent Transitions (HAT) program Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Healthy Adolescent Transitions (HAT): A Comprehensive Approach to Targeting Adolescent Mothers
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Intervention Condition

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

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194672


Locations
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United States, Ohio
OhioHealth Innovation Institute
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Jack Stevens
OhioHealth Research and Innovation Institute
Investigators
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Principal Investigator: Jack Stevens, PhD Nationwide Children's Hospital

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Responsible Party: Jack Stevens, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03194672     History of Changes
Other Study ID Numbers: 90AP2678-01-00
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: de-identified data base will be available at conclusion of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No