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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

My Health Coach

About this trial

This is an interventional treatment trial for Fetal Alcohol Spectrum Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mt. Hope Family Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

My Health Coach

Arm Description

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

Outcomes

Primary Outcome Measures

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 8-item measure of subjective well-being. The Intellectual Disability Version uses more concrete item wording and a 5-point visual scale. Ratings are summed and range from 8 to 40. Higher scores reflect better perceived well-being. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.

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, with summed scores ranging from 8 to 40. 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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.

Mean change in competence 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, with summed scores ranging from 8 to 40. 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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.

Mean change in relatedness 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, with summed scores ranging from 8 to 40. 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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.

Secondary Outcome Measures

Full Information

NCT ID

NCT05604014

First Posted

October 28, 2022

Last Updated

October 13, 2023

Sponsor

University of Rochester

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT05604014

Brief Title

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

Official Title

Feasibility Study of the My Health Coach App for Adults With Fetal Alcohol Spectrum Disorders (FASD)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

March 21, 2023 (Actual)

Primary Completion Date

August 31, 2023 (Actual)

Study Completion Date

August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fetal Alcohol Spectrum Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

My Health Coach

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

My Health Coach

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean change in subjective well-being from baseline to 6-week follow-up on the Personal Well-Being Index - Intellectual Disability Version

Description

The Personal Well-Being Index (PWI) is an 8-item measure of subjective well-being. The Intellectual Disability Version uses more concrete item wording and a 5-point visual scale. Ratings are summed and range from 8 to 40. Higher scores reflect better perceived well-being. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.

Time Frame

Baseline to 6 Weeks

Title

Mean change in autonomy ratings from baseline to 6-week follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy sub-scale

Description

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, with summed scores ranging from 8 to 40. 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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.

Time Frame

Baseline to 6 Weeks

Title

Mean change in competence ratings from baseline to 6-week follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy sub-scale

Description

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, with summed scores ranging from 8 to 40. 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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.

Time Frame

Baseline to 6 Weeks

Title

Mean change in relatedness ratings from baseline to 6-week follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy sub-scale

Description

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, with summed scores ranging from 8 to 40. 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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.

Time Frame

Baseline to 6 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Facility Information:

Facility Name

Mt. Hope Family Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14608

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified participant data will be deposited within the Collaborative Initiative on FASD (CIFASD) Central Repository and the National Institute on Alcohol Abuse and Alcoholism Data Archive as required by grant regulations. CIFASD Data Sharing policies and data access request information can be found at: https://cifasd.org/data-sharing/. NIAAA-DA access can be found at: https://nda.nih.gov/niaaa/

IPD Sharing Time Frame

All collection data are shared automatically two years after the grant end date.

IPD Sharing Access Criteria

See https://nda.nih.gov/niaaa/ for details.

IPD Sharing URL

https://nda.nih.gov/niaaa/

Fetal Alcohol Spectrum Disorders

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial