Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05028517
Other study ID # STUDY00006555
Secondary ID U01AA026104
Status Completed
Phase N/A
First received
Last updated
Start date January 6, 2022
Est. completion date December 31, 2022

Study information

Verified date January 2024
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test a new smartphone "app" for parents/caregivers of children with fetal alcohol spectrum disorder (FASD). The app is called Families Moving Forward (FMF) Connect. The goal of the app is to provide parents/caregivers with useful information to help manage their children's condition and obtain peer support.


Recruitment information / eligibility

Status Completed
Enrollment 129
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Biological parent or other primary caregiver (e.g., foster or adoptive parent, relative, legal guardian) of a child with FASD or prenatal alcohol exposure (PAE) - The parent/caregiver must be at least 18 years old - The child must between the ages of 3 and 12 years old - The child has a diagnosis of FASD or has confirmed PAE - The child has lived with the parent/caregiver for at least 4 months and is expected to remain in the home for at least 1 year - The parent/caregiver lives in the United States - The parent/caregiver has a smartphone or ipad with iOS operating system Exclusion Criteria: - The parent/caregiver is not fluent in English (the FMF Connect app and pre-post measures are currently only available in English) - There is another parent/caregiver of the same child or living in the home that is already enrolled in the study (couples are excluded to prevent dependence in the data) - The family has previously received or is currently receiving the therapist-led Families Moving Forward (FMF) Program

Study Design


Related Conditions & MeSH terms


Intervention

Other:
FMF Connect
The FMF Connect intervention includes cloud infrastructure and an innovative, multilayered mobile app. It incorporates tailored content for parents/caregivers of children (ages 3-12) with FASD or PAE. The app integrates five main components: 1) Dashboard; 2) Learning Modules; 3) Family Forum; 4) Library; and 5) Notebook. Weekly emails are also sent to support motivational engagement.
Coaching
A text-based coaching module is added to the FMF Connect app. Coaches support continued use of the app and individualized goal setting.

Locations

Country Name City State
United States University of Rochester Medical Center Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up The Eyberg Child Behavior Inventory measures the intensity of child behavior problems. Scores are presented as T-scores with a mean of 50 and a standard deviation of 10. A T-score of 60 or higher is considered clinically significant. Higher scores indicate more intense behavior problems. baseline to 12 weeks
Primary Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Sensory Avoid scale measures attributions of behavior based on sensory avoidance. It ranges from 5 to 30 with higher scores reflecting greater agreement with neurodevelopmental attributions. baseline, 6 weeks, 12 weeks
Primary Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Sensory Seek scale measures attributions of behavior based on sensory seeking. It ranges from 5 to 30 with higher scores reflecting greater agreement with neurodevelopmental attributions. baseline, 6 weeks, 12 weeks
Primary Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Task Willful scale measures attributions of behavior based on willful task avoidance. It ranges from 3 to 18 with higher scores reflecting greater agreement with willful attributions. baseline, 6 weeks, 12 weeks
Primary Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Task Ability scale measures attributions of behavior based on ability to complete tasks. It ranges from 5 to 30 with higher scores reflecting greater agreement with neurodevelopmental attributions. baseline, 6 weeks, 12 weeks
Primary Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Disruptive Behavior scale measures attributions of behavior based on purposeful disruptive behavior. It ranges from 5 to 30 with higher scores reflecting greater agreement with willful attributions. baseline, 6 weeks, 12 weeks
Primary Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Emotional Support scale measures attributions of behavior based on need for emotional support. It ranges from 4 to 24 with higher scores reflecting greater agreement with neurodevelopmental attributions. baseline, 6 weeks, 12 weeks
Primary Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Dysregulated Behavior scale measures attributions of behavior based on dysregulated behavior. It ranges from 3 to 18 with higher scores reflecting greater agreement with neurodevelopmental attributions. baseline, 6 weeks, 12 weeks
Primary Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The efficacy sub-scale reported here measures how effective parents feel they are and includes 7 items, rated on a scale from 1 ("strongly agree") to 6 ("strongly disagree"). Responses are summed, with possible sub-scale score range from 7 to 42 with higher scores indicating lower feelings of efficacy. baseline, 6 weeks, 12 weeks
Primary Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The satisfaction sub-scale reported here includes 9 items, rated on a scale from 1 ("strongly agree") to 6 ("strongly disagree"). Responses are summed, with possible sub-scale score range from 9 to 54 with higher scores indicating higher satisfaction in the parenting role. baseline, 6 weeks, 12 weeks
Primary Family Needs Questionnaire Baseline to 12-Week Follow-up The family needs questionnaire measures the degree to which family needs are met. The scale includes 18 items reflecting family needs that are rated on a scale from 0 to 4, with 0 being not applicable to 4 being met a great deal. The total score on this measure is created by summing across all items. Total score ranges from 0-72. Higher scores reflect more needs being met. baseline to 12 weeks
Primary FASD Knowledge at Baseline and 12-Week Follow-up The Knowledge and Advocacy questionnaire assesses caregiver knowledge about FASD and advocacy and ranges from 0 to 28. Higher scores reflect greater knowledge. baseline to 12 weeks
Secondary Participant Perception of Self-care Change Over Intervention Period Reported at 12-week Follow-up Participants are asked at follow-up to rate how much their self-care practices have changed over the last 3 months on a 5-point scale ranging from "A lot less self-care (1)" to "A lot more self-care (5)." A score of 3 equates to no change. 12 weeks
Secondary Mean App Quality Score on Mobile App Rating Scale: User Version The mobile app rating scale includes a measure of users perception of app quality. There are 16 items contributing to this score, each rated on a scale from 1 to 5. Total app quality score is presented as a mean with range of 1 to 5, with higher scores reflecting greater perceived quality of the app. 12 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A
Completed NCT01961050 - Preventing FAS/ARND in Russian Children N/A
Recruiting NCT05108974 - Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study Phase 2
Completed NCT02457676 - Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention N/A
Recruiting NCT06005181 - The Synchrony Study: Examining Music Training for Children With FASD N/A
Completed NCT04571463 - Ethyl Glucuronide in Urine Samples of Pregnant Women Within the HUS ja PHHYKY Area
Completed NCT03361293 - Cognitive Training and tDCS for Children With FASD N/A
Recruiting NCT05534568 - The Oklahoma Parent-Child Assistance Program N/A
Recruiting NCT05456321 - CIFASD 5 tDCS and Cognitive Training N/A
Completed NCT01911299 - Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders Phase 2
Recruiting NCT04332172 - Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy N/A
Recruiting NCT05960461 - Families Moving Forward (FMF) Connect Pro for Mental Health Providers N/A
Completed NCT05604014 - Feasibility Study of the My Health Coach App for Adults With FASD N/A
Terminated NCT03852550 - READYorNot[TM] Brain-Based Disabilities Trial N/A
Completed NCT02735473 - Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Phase 2
Completed NCT03782935 - Nutritional Risk Factors for FASD in Ukraine N/A
Not yet recruiting NCT04918043 - Alcohol Use During Pregnancy in Finland According to Meconium Samples
Completed NCT04072809 - Dissecting the Genetics of Fetal Alcohol Spectrum Disorders
Completed NCT01149538 - Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure Phase 1/Phase 2
Completed NCT04194489 - Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention N/A