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

NCT05604014 | Completed Results

• 2 other identifiers: 00007749UH2AA029050
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fetal Alcohol Spectrum Disorders

Outcome Measures

Primary Outcomes (4)

• Mean Change in Subjective Well-being From Baseline to 6-week Follow-up on the Personal Well-Being Index - Intellectual Disability Version

  The Personal Well-Being Index (PWI) is an 7-item measure of subjective well-being. The Intellectual Disability Version uses more concrete item wording and a 5-point visual scale. Ratings are averaged and the mean total is reported ranging from 1 to 5. Higher scores reflect better perceived well-being.

  Baseline to 6 Weeks

• Mean Change in Autonomy Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy Sub-scale

  The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSF) is a 24-item scale assessing both satisfaction and frustration relating to the three basic psychological needs identified in self-determination theory: autonomy, competence, and relatedness. Items are rated on a 5-point scale from 1 "not at all true" to 5 "completely true." Each sub-scale has 8 items. Scores were averaged across items with reported mean ranging from 1 to 5. Higher scores reflect higher satisfaction or need being met to a higher degree. The Autonomy sub-scale measures how much a person feels they have choice in what they do in their everyday life.

  Baseline to 6 Weeks

• Mean Change in Competence Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Competence Sub-scale

  The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSF) is a 24-item scale assessing both satisfaction and frustration relating to the three basic psychological needs identified in self-determination theory: autonomy, competence, and relatedness. Items are rated on a 5-point scale from 1 "not at all true" to 5 "completely true." Each sub-scale has 8 items. Scores were averaged across items with reported mean ranging from 1 to 5. Higher scores reflect higher satisfaction or need being met to a higher degree. The Competence sub-scale measures how much a person feels they are successful or do a good job on things in their life.

  Baseline to 6 Weeks

• Mean Change in Relatedness Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Relatedness Sub-scale

  The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSF) is a 24-item scale assessing both satisfaction and frustration relating to the three basic psychological needs identified in self-determination theory: autonomy, competence, and relatedness. Items are rated on a 5-point scale from 1 "not at all true" to 5 "completely true." Each sub-scale has 8 items. Scores were averaged across items with reported mean ranging from 1 to 5. Higher scores reflect higher satisfaction or need being met to a higher degree. The Relatedness sub-scale measures how much a person feels connected to other people in their life.

  Baseline to 6 Weeks

Study Arms (1)

My Health Coach

EXPERIMENTAL

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

Behavioral: My Health Coach

Interventions

My Health Coach 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.

My Health Coach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Mt. Hope Family Center

Rochester, New York, 14608, United States

Location

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: Christie L. M. Petrenko, Ph.D.
• Organization: Mt. Hope Family Center, University of Rochester

christie_petrenko@urmc.rochester.edu

5852752991

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 3, 2022
• Study Start: March 21, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: October 4, 2024
• Results First Posted: October 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: All collection data are shared automatically two years after the grant end date.
• Access Criteria: See https://nda.nih.gov/niaaa/ for details.

Locations

US (1)