Healthy Adolescent Transitions (HAT) (HAT)
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|ClinicalTrials.gov Identifier: NCT03194672|
Recruitment Status : Active, not recruiting
First Posted : June 21, 2017
Last Update Posted : October 17, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Experimental: Intervention Condition
This experimental condition has three major components:
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.
- 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
- Nicotine use [ Time Frame: 21 months post enrollment ]Use of cigarettes and vapor products
- Financial literacy [ Time Frame: 21 months post enrollment ]Understanding of financial terminology
- School completion [ Time Frame: 21 months post enrollment ]Highest grade completed
- Medical home [ Time Frame: 21 months post enrollment ]Use of primary care services
- Healthy eating behaviors [ Time Frame: 21 months post enrollment ]Eating nutritional food according to items from Youth Risk Behavior Survey
- Employment [ Time Frame: 21 months post enrollment ]Number of hours worked per week
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
|United States, Ohio|
|OhioHealth Innovation Institute|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Jack Stevens, PhD||Nationwide Children's Hospital|