Clinical trial NCT05028517: Efficacy Trial of the FMF Connect Mobile Health Intervention
Official title: Efficacy Trial of the FMF Connect Mobile Health Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-08-31
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study involves a three arm randomized controlled trial with equal allocation to the following conditions: (1) FMF Connect + coaching, (2) FMF Connect alone, and (3) waitlist control. Quantitative survey data will be collected at three timepoints: baseline (T1), 6-weeks (T2), and 12-weeks (T3).
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up
timeFrame: baseline to 12 weeks
measure: Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks
timeFrame: baseline, 6 weeks, 12 weeks
measure: Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks
timeFrame: baseline, 6 weeks, 12 weeks
measure: Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks
timeFrame: baseline, 6 weeks, 12 weeks
measure: Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks
timeFrame: baseline, 6 weeks, 12 weeks
measure: Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
timeFrame: baseline, 6 weeks, 12 weeks
measure: Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks
timeFrame: baseline, 6 weeks, 12 weeks
measure: Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
timeFrame: baseline, 6 weeks, 12 weeks
measure: Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up
timeFrame: baseline, 6 weeks, 12 weeks
measure: Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up
timeFrame: baseline, 6 weeks, 12 weeks
measure: Family Needs Questionnaire Baseline to 12-Week Follow-up
timeFrame: baseline to 12 weeks
measure: FASD Knowledge at Baseline and 12-Week Follow-up
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Participant Perception of Self-care Change Over Intervention Period Reported at 12-week Follow-up
timeFrame: 12 weeks
measure: Mean App Quality Score on Mobile App Rating Scale: User Version
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: