Clinical trial NCT04453657: Tele-Wellness Supported App for Family Child Care Home Providers and Families to Promote Health, Family Engagement, and School Readiness Amid COVID-19
Official title: Adapting and Delivering a Tele-Wellness Supported Digital Toolkit to Baltimore City's Approved Family Child Care Home Providers Caring for Children of Essential Workers: Promoting Health, Early Literacy, and Quality Parent Engagement Amid COVID-19: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stress, Psychological
Child Behavior
Social Competence
Keywords: Family Child Care Home Providers
Parents
Young Children
Multi-component Self-Care
Tele-Wellness Service
Child care provider stress
Child care provider informational support
Behavior and Social functioning in Children
Educational learning games
Parent Engagement
Early Learning Intervention
Parenting
Social emotional learning games
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 270
Sex: ALL
Minimum age (years): 3
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators aim to deliver a tele-wellness supported app to Baltimore City's Family Child Care Home (FCCH) providers who are caring for children of Essential Personnel. Once a pre-survey is conducted, login information will be assigned to 30 Family Child Care Home providers and parents the FCCH serve. Providers and Parents will receive self-care and parenting/parent engagement support through the app and through a tele-wellness service, Ask a Nurse, provided by community health nurses at the Johns Hopkins School of Nursing. Children will have access to gamified learning materials in early literacy, math, social-emotional learning, and nutrition.

Detailed description: The investigators will adapt and deliver a tele-wellness supported digital toolkit via an app for Baltimore City's Family Child Care Home (FCCH) providers and the families the FCCH serve. Through this digital toolkit, the investigators aim to provide related self-care support, parent/parent engagement support for both Family Child Care Home providers and parents, and provide access to early literacy, math, social-emotional learning, and nutrition games for children (3-6 years old). Additionally, Family Child Care Home providers and parents will have access to a hotline and email to the Ask a Nurse program-a tele-wellness program run by community registered nurses at Johns Hopkins School of Nursing. Through Ask a Nurse, providers and parents will be able to receive wellness counseling from licensed registered nurses and care coordination to address specific social needs. The tele-wellness service is NOT intended to directly address health issues, diagnose, or prescribe. In summary, Family Child Care Home providers will have access to self-care and parent engagement resources and parents will have access to self-care and parenting resources in addition to the games for the child(ren).

The first phase of this study is to tailor an existing app, Escribo Play that already has gamified early literacy and math tools, and expand its scope by including self-care and parenting/parent engagement support for Family Child Care Home Providers and the parents the FCCH serve. Additionally, the investigators are creating gamified social-emotional learning and nutrition games for the children.

The second phase is a pre-post test where the investigator will recruit FCCH providers enrolled in the Essential Personnel Child Care or School-Aged program and the parents the FCCH serve to fill out health surveys before and 15 weeks post engagement with the app.

The investigators hypothesize that engagement with the digital toolkit will improve provider and parental perceived level of stress, informational support, access to learning games, as well as social, emotional, and behavioral functioning in children.

Eligibility criteria: Inclusion Criteria:

* Licensed Family Child Care Home Providers operating in Baltimore City who are approved or was once approved to remain open during COVID-19 through the Essential Personnel Child Care or School-Aged Program.
* Parents or legal adult guardians of young children (3-6 years old) who have utilized or continue to utilize the services of Family Child Care Home providers enrolled in the study.
* All participants must have access to a smartphone, tablet, or computer.

Exclusion Criteria:

* Licensed Family Child Care Home Providers not enrolled or was never enrolled in the Essential Personnel Child Care or School-Aged Program
* Parents of young children (3-6 years old) who have not utilized the services of Licensed Family Child Care Home Providers in the Essential Personnel Child Care or School-Aged Program
* FCCH providers not operating in Baltimore City
* FCCH providers who do not have at least 1 parent consenting to participate in the study.

Primary outcomes:
measure: Change in Perceived Level of Stress as assessed by the Perceived Stress Scale
timeFrame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
measure: Change in Perceived Level of Informational Support as assessed by the PROMIS Informational Support Short Form
timeFrame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
measure: Change in Awareness of the Maryland Early Childhood Family Engagement Framework and Toolkit as assessed by a survey question
timeFrame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
measure: Change in Social, Emotional, and Behavior Functioning in Children as assessed by the Social Competence and Behavior Evaluation for Children
timeFrame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Secondary outcomes:
measure: Change in Quality of the Parent-Child Care Relationship as assessed by the Supportive Parent-Caregiver Relationship Subscale
timeFrame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lucine Francis, PhD
role: PRINCIPAL_INVESTIGATOR
References: