Fetal Alcohol Spectrum Disorders
Conditions
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.
Interventions
BEHAVIORALMy 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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Subjective Well-being From Baseline to 6-week Follow-up on the Personal Well-Being Index - Intellectual Disability Version | Baseline to 6 Weeks | 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. |
| Mean Change in Autonomy Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy Sub-scale | Baseline to 6 Weeks | 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. |
| Mean Change in Competence Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Competence Sub-scale | Baseline to 6 Weeks | 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. |
| Mean Change in Relatedness Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Relatedness Sub-scale | Baseline to 6 Weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
Of the 95 enrolled in the study, 52 were excluded for the following reasons: 2 did not meet eligibility criteria, 1 declined to participate, 5 had incomplete screening data, 7 were duplicates, and 37 were suspected fraudulent participants.
Participants by arm
| Arm | Count |
|---|---|
| My Health Coach Participants receive the My Health Coach app and try it on their personal smartphones for 6 weeks.
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. | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 13 |
Baseline characteristics
| Characteristic | My Health Coach |
|---|---|
| Age, Continuous | 28.1 years STANDARD_DEVIATION 11.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Region of Enrollment Canada | 7 Participants |
| Region of Enrollment Ireland | 1 Participants |
| Region of Enrollment Italy | 1 Participants |
| Region of Enrollment Netherlands | 4 Participants |
| Region of Enrollment New Zealand | 1 Participants |
| Region of Enrollment South Africa | 1 Participants |
| Region of Enrollment United Kingdom | 4 Participants |
| Region of Enrollment United States | 24 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
Primary
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.
Time frame: Baseline to 6 Weeks
Population: Participants with completed data at both baseline and 6-week follow-up timepoints were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| My Health Coach | Mean Change in Autonomy Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy Sub-scale | Baseline | 3.38 units on a scale | Standard Deviation 0.59 |
| My Health Coach | Mean Change in Autonomy Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy Sub-scale | 6-Week follow-up | 3.46 units on a scale | Standard Deviation 0.49 |
p-value: 0.5t-test, 2 sided
Primary
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.
Time frame: Baseline to 6 Weeks
Population: Participants with complete data at both baseline and 6-week follow-up timepoints were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| My Health Coach | Mean Change in Competence Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Competence Sub-scale | Baseline | 3.12 units on a scale | Standard Deviation 0.67 |
| My Health Coach | Mean Change in Competence Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Competence Sub-scale | 6-week follow-up | 3.32 units on a scale | Standard Deviation 0.5 |
p-value: 0.16t-test, 2 sided
Primary
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.
Time frame: Baseline to 6 Weeks
Population: Participants with completed data at both baseline and 6-week follow-up timepoints were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| My Health Coach | Mean Change in Relatedness Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Relatedness Sub-scale | Baseline | 3.48 units on a scale | Standard Deviation 0.69 |
| My Health Coach | Mean Change in Relatedness Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Relatedness Sub-scale | 6-week Follow-up | 3.58 units on a scale | Standard Deviation 0.58 |
p-value: 0.44t-test, 2 sided
Primary
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.
Time frame: Baseline to 6 Weeks
Population: Participants with complete data at baseline and 6-week follow-up surveys are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| My Health Coach | Mean Change in Subjective Well-being From Baseline to 6-week Follow-up on the Personal Well-Being Index - Intellectual Disability Version | Baseline | 3.51 units on a scale | Standard Deviation 0.68 |
| My Health Coach | Mean Change in Subjective Well-being From Baseline to 6-week Follow-up on the Personal Well-Being Index - Intellectual Disability Version | 6-Week Follow-up | 3.59 units on a scale | Standard Deviation 0.69 |
p-value: 0.49t-test, 2 sided