Feasibility Study of the My Health Coach App for Adults With FASD

NCT ID: NCT05604014

Last Updated: 2024-10-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2023-08-31

Brief Summary

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The purpose of this study is to test a new smartphone "app" for adults with fetal alcohol spectrum disorder (FASD). The app is called My Health Coach. The goal of the app is to provide adults with useful information and tools to help manage their health and well-being.

Detailed Description

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Conditions

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Fetal Alcohol Spectrum Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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My Health Coach

Participants receive the My Health Coach app and try it on their personal smartphones for 6 weeks.

Group Type EXPERIMENTAL

My Health Coach

Intervention Type BEHAVIORAL

My Health Coach is a self-directed mobile health intervention for adults with FASD. It is grounded in self-determination theory and integrates well-established behavior change strategies. It has a cloud-based infrastructure and uses a just-in-time adaptive intervention design and a simple and engaging chatbot interface. It provides adults just the right type and amount of support, when they are most receptive.

Interventions

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My Health Coach

My Health Coach is a self-directed mobile health intervention for adults with FASD. It is grounded in self-determination theory and integrates well-established behavior change strategies. It has a cloud-based infrastructure and uses a just-in-time adaptive intervention design and a simple and engaging chatbot interface. It provides adults just the right type and amount of support, when they are most receptive.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adult 18 years or older
* Have a fetal alcohol spectrum disorder (FASD) or history of prenatal alcohol exposure
* Have conversational fluency in English
* Own an smartphone

Exclusion Criteria

* Unable to complete measures or interviews in English
* Do not have a smartphone
* Under 18
* Do not have an FASD or history or prenatal alcohol exposure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Christie Petrenko

Research Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mt. Hope Family Center

Rochester, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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UH2AA029050

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00007749

Identifier Type: -

Identifier Source: org_study_id

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