Pregnancy PreventionPhase 2HATNCT03194672
Healthy Adolescent Transitions (HAT)
A Phase 2 study testing Healthy Adolescent Transitions (HAT) program in people with Pregnancy Prevention and Life Skill Development, run by Jack Stevens at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 14 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Prevention, Life Skill Development
- What is being tested?
- Healthy Adolescent Transitions (HAT) program
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 2 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
OhioHealth Innovation Institute
Columbus, Ohio, 43205
About this study
Official title: 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.
- Conditions
- Pregnancy Prevention, Life Skill Development
- Being tested
- Healthy Adolescent Transitions (HAT) program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Adolescent Transitions (HAT) programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long acting reversible contraception
Use of long acting reversible contraception
Measured: 12 months post enrollment
Repeat pregnancy
Repeat pregnancy
Measured: 21 months post enrollment
Secondary outcomes (6)
Nicotine use
Use of cigarettes and vapor products
Measured: 21 months post enrollment
Financial literacy
Understanding of financial terminology
Measured: 21 months post enrollment
School completion
Highest grade completed
Measured: 21 months post enrollment
Medical home
Use of primary care services
Measured: 21 months post enrollment
Healthy eating behaviors
Eating nutritional food according to items from Youth Risk Behavior Survey
Measured: 21 months post enrollment
Employment
Number of hours worked per week
Measured: 21 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start14 Aug 2017
- Primary completion2 Mar 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jack Stevens
- Sponsor type
- University, hospital or other
- Collaborators
- OhioHealth Research and Innovation Institute
- Responsible party
- Sponsor-investigator, Jack Stevens, Nationwide Children's Hospital
- Investigators
- Jack Stevens, PhD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194672
- Sponsor's protocol ID
- 90AP2678-01-00
- Acronym
- HAT
- Status last verified
- Mar 2024
- First submitted
- 19 Jun 2017
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified data base will be available at conclusion of the study
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 Apr;25(3):509-520. doi: 10.1007/s11121-024-01660-3. Epub 2024 Mar 2.
PubMed 38429618
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Adolescent Transitions (HAT): A Comprehensive Approach to Targeting Adolescent Mothers
- ClinicalTrials.gov ID
- NCT03194672
- Acronym / sponsor ID
- HAT / 90AP2678-01-00
- Conditions
- Pregnancy Prevention, Life Skill Development
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Jack StevensUniversity, hospital or other
- Collaborators
- OhioHealth Research and Innovation Institute
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Behavioral: Healthy Adolescent Transitions (HAT) programThis 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. |
| 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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age 14-19 years
- 24-35 weeks gestation
- Medicaid insurance
- Central Ohio resident
- English speaking
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Adolescent Transitions (HAT) programThe 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. | Behavioural | Intervention Condition |
Primary outcome
Long acting reversible contraception
Time frame: 12 months post enrollment
Use of long acting reversible contraception
Repeat pregnancy
Time frame: 21 months post enrollment
Repeat pregnancy
6 secondary outcomes
Nicotine use
Time frame: 21 months post enrollment
Financial literacy
Time frame: 21 months post enrollment
School completion
Time frame: 21 months post enrollment
Medical home
Time frame: 21 months post enrollment
Healthy eating behaviors
Time frame: 21 months post enrollment
Employment
Time frame: 21 months post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Results publication: PubMed 38429618Stevens 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.
- Individual participant dataSharing planned: Yes. de-identified data base will be available at conclusion of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack Stevens, PhD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Healthy Adolescent Transitions (HAT) program in people with Pregnancy Prevention and Life Skill Development, run by Jack Stevens at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long acting reversible contraception (time frame: 12 months post enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03194672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.