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

University of Rochester

Status: Enrolling

Conditions: Fetal Alcohol Spectrum Disorders

Treatments: Behavioral: Thrive Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07016009

STUDY00010579

Details and patient eligibility

About

This study evaluates the Thrive person centered planning program for young adults with fetal alcohol spectrum disorders. Participants are randomized to either an immediate start or delayed start group for the psychoeducation phase. Following this phase, participants are randomized again to receive the intervention in either an individual or group based format. Participants complete repeated online assessments at multiple timepoints over approximately 10 months to evaluate whether the program improves goal setting, social support, and quality of life.

Full description

This study is a randomized, multi stage trial with two sequential randomization timepoints. At baseline, participants are randomized to either an immediate start psychoeducation group or a delayed start group. After completion of the psychoeducation phase, participants undergo a second randomization to receive the intervention in either an individual or group based goal setting format. This results in four study arms representing combinations of intervention timing and delivery format. Participants complete repeated assessments at multiple timepoints over approximately 10 months to evaluate effectiveness, goal setting format differences, and maintenance of outcomes.

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

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60 participants in 4 patient groups

Immediate Start Individual Format

Experimental group

Description:

Participants receive psychoeducation immediately followed by individual goal setting, planning, and implementation sessions.

Treatment:

Behavioral: Thrive Program

Immediate Start Group Format

Experimental group

Description:

Participants receive psychoeducation immediately followed by group based goal setting sessions involving their social support network.

Treatment:

Behavioral: Thrive Program

Delayed Start Individual Format

Experimental group

Description:

Participants complete a delay period prior to receiving psychoeducation followed by individual goal setting, planning, and implementation sessions.

Treatment:

Behavioral: Thrive Program

Delayed Start Group Format

Experimental group

Description:

Participants complete a delay period prior to receiving psychoeducation followed by group based goal setting sessions involving their social support network.

Treatment:

Behavioral: Thrive Program