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Thrive Person-Centered Planning Program for Young Adults With Fetal Alcohol Spectrum Disorders

University of Rochester logo

University of Rochester

Status

Not yet enrolling

Conditions

Fetal Alcohol Spectrum Disorders

Treatments

Behavioral: Thrive Program

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT07016009
STUDY00010579
1R61AA030780 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study is testing a new program called Thrive. The Thrive program was developed for young adults with fetal alcohol spectrum disorders (FASD). Thrive uses a person-centered planning approach, which means it focuses on what is most important to the young adult with FASD. The young adult invites people that support them to help them make plans to meet their goals. 60 young adults with FASD will participate in this study. Half of the young adults will try out the Thrive program immediately. The other half will be on a waitlist and will get to start the program about 8 months later. Everyone completes online surveys at three times during the study. They do surveys at the beginning of the study, after 4 months, and after 8 months. The goal of the study is to test if the Thrive program helps young adults meet their goals and get support when they need it.

Full description

This type 1 hybrid effectiveness-implementation trial proposes a 2-arm parallel pilot RCT design. A total of 60 young adults with FASD will be randomly assigned into the (1) Thrive intervention or the (2) waitlist comparison group using a 50:50 allocation ratio. As this is a type 1 hybrid trial, measurement emphasizes effectiveness outcomes, with collection of some implementation outcomes/process to inform planning of subsequent larger scale community trials. Consistent with the pilot RCT design, analysis will focus on determining feasibility of the intervention, trial procedures and measurement, and intervention process. This information will optimize success of the planned R01 larger-scale RCT.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Young adult between the ages of 18 and 25
  • Lives in the United States
  • Has a diagnosis of fetal alcohol spectrum disorder or confirmed prenatal alcohol exposure

Exclusion criteria

  • Does not have access to the internet or data plan allowing video conferencing
  • Is not able to listen or speak in English

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Thrive Program
Experimental group
Treatment:
Behavioral: Thrive Program
Waitlist Comparison Group
No Intervention group

Trial contacts and locations

1

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Central trial contact

Christie Petrenko, Ph.D.

Data sourced from clinicaltrials.gov

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