Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention

NCT04194489 | Completed Results

• 2 other identifiers: 4433U01AA026104
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Alcohol Spectrum Disorders

Outcome Measures

Primary Outcomes (4)

• Eyberg Child Behavior Inventory at Baseline and 3-Month 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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.

  baseline to 3-month follow-up

• Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month 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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.

  baseline to 3-month follow-up

• Parenting Sense of Competence - Efficacy Sub-scale Baseline to 3-Month 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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.

  baseline to 3-month follow-up

• Family Needs Questionnaire Baseline to 3-Month Follow-up

  The family needs questionnaire measures the degree to which family needs are met. The scale includes 20 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 averaging across all items. Total score ranges from 0-4. Higher scores reflect more needs being met. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.

  baseline to 3-month follow-up

Secondary Outcomes (2)

• Participant Perception of Self-care Change Over Intervention Period Reported at 3-month Follow-up

  3-month follow-up

• Mean App Quality Score on Mobile App Rating Scale: User Version

  3-month follow-up

Study Arms (1)

FMF Connect Intervention

EXPERIMENTAL

Other: FMF Connect

Interventions

FMF Connect OTHER

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.

FMF Connect Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 with iOS or Android operating system

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, 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

Limitations and Caveats

This study was designed to assess intervention and trial feasibility rather than test efficacy. Effect sizes were calculate to estimate sensitive of selected measures to change and inform refinements prior to RCT. Also note, Android participants completed study procedures almost a year later than iOS due to COVID-19 pandemic-related project delays.

Results Point of Contact

• Title: Dr. Christie Petrenko
• Organization: Mt. Hope Family Center, University of Rochester

christie.petrenko@rochester.edu

(585) 275-2991

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: Assistant Professor

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: January 31, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: December 11, 2023
• Results First Posted: November 4, 2022

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: It will be available once the data is collected and will be available indefinitely.

Locations

US (1)