Stress, PsychologicalNCT04453657
Tele-Wellness Supported App for Family Child Care Home Providers and Families to Promote Health, Family Engagement, and School Readiness Amid COVID-19
A study testing FamilyChildCare (provisional name of app) in people with Stress, Psychological and Child Behavior, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Child Behavior, Social Competence
- What is being tested?
- FamilyChildCare (provisional name of app)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
About this study
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
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.
Read the 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.
- Conditions
- Stress, Psychological, Child Behavior, Social Competence
- Being tested
- FamilyChildCare (provisional name of app)
- 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
- Medical subject headings
- Stress, Psychological, Child Behavior, Social Skills, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamilyChildCare (provisional name of app)Device
Parents will provide their child(ren) access to a smartphone, tablet, or computer for approximately 30 minutes, three times per week for 15 weeks with a total dosage of instruction of about 22.5 hours. Parents and providers will receive self-care, parenting, and parent engagement tips and resources through push notifications twice a day. Additionally, daily reminders will be sent to parents through push notification to give their child(ren) access to the learning games. After 15 weeks of app engagement, the providers and parents will be contacted by the PI to notify them of the 15 week time mark and provide the information for post-surveys via Qualtrics.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | There is only one arm in this study. All recruited and consented participants will fill out a pre-survey, engage with the digital toolkit for 15 weeks, then fill out a post-survey. Receives: Device: FamilyChildCare (provisional name of app) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Level of Stress as assessed by the Perceived Stress Scale
Family Child Care Home Providers \& Parents: Perceived Stress Scale (PSS)-10 is a 10-item tool widely used to measure the degree to which circumstances in one's life are deemed as stressful in the general population. The PSS was designed for use in community samples with at least a junior high school education. The items are easy to understand, and the response alternatives are simple to grasp. Six items of the PSS-10 are negatively phrased (item 1, 2, 3, 6, 9, 10; negative perception subscale, while the remaining four (item 4, 5, 7 and 8; positive perception subscale) are positively phrased items and require reverse coding. Total PSS-10 score will be calculated by summing scores. A total score ranges 0-40 where a higher score indicates higher perceived stress.
Measured: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Change in Perceived Level of Informational Support as assessed by the PROMIS Informational Support Short Form
Family Child Care Home Providers \& Parents: Patient-Reported Outcomes Measurement Information System (PROMIS) Informational Support Short Form 8a assesses the perceived availability of helpful information or advice. It is an 8-item tool and each item has 5 response options ranging in values from one to five-1=Never 2=Rarely 3=Sometimes 4=Usually 5=Always with a range of 8-40. Total raw scores, sum of values to responses, will be calculated. A Score conversion table found in the Appendix of the tool will be used to translate the total raw score or pro-rated score into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.
Measured: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Change in Awareness of the Maryland Early Childhood Family Engagement Framework and Toolkit as assessed by a survey question
Family Child Care Home providers will be asked in the pre/post-surveys whether they are aware of the existence of the Maryland Early Childhood Family Engagement Framework and Toolkit- a 91-page document developed by the Maryland State Department of Education to guide child care providers in best practices for family engagement. Family Child Care Home providers will respond either
- Yes, I am aware of it but have not read it ii. Yes, I am aware of it and have read the report iii. No, I am not aware of it
Measured: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Change in Social, Emotional, and Behavior Functioning in Children as assessed by the Social Competence and Behavior Evaluation for Children
The social, emotional, and behavioral functioning in children will be assessed by parents responding to items on the Social Competence and Behavior Evaluation for Children: The Short Form (SCBE)-30. It is a 30 item tool with a 6 point response option- Never (1), Sometimes (2 or 3), Often (4 or 5), or Always (6). The SCBE-30 has three subscales (10 items each): Anger-Aggression (cronbach's α = 0.93 in the current sample), Anxiety-Withdrawal (cronbach's α = 0.87), and Social Competence (cronbach's α = 0.89). The SCBE-30 was developed for children from ages three to six and has been shown to have high interrater and test-retest reliability and internal consistency. Sums of each subscale will be calculated.
Measured: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Secondary outcomes (1)
Change in Quality of the Parent-Child Care Relationship as assessed by the Supportive Parent-Caregiver Relationship Subscale
Family Child Care Home Provider and Parents: The Supportive Parent-Caregiver Relationship Sub-scale from Scales Measuring Aspects of Child-Care Quality Supportive Parent-Caregiver Relationship assess the perceived quality of the Parent-Child Care Relationship. The provider report contains 6 items with a 5 point response scale-1=Never, 2=Rarely, 3=Sometimes, 4=Often, or 5=Always. The scale will be adapted to ask about the general relationship to all parents, not any specific parent. The parent report contains 6 items with a 5 point response scale-1=Never, 2=Rarely, 3=Sometimes, 4=Often, or 5=Always. The mean score \& alpha will be reported. Reported Mean=26.9, SD=3.4, Alpha=.84)
Measured: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start4 Feb 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Continuing to pursue additional funding to continue with the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucine Francis, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453657
- Sponsor's protocol ID
- IRB00250864
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2020
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04453657
- Acronym / sponsor ID
- IRB00250864
- 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
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Continuing to pursue additional funding to continue with the study
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: FamilyChildCare (provisional name of app)There is only one arm in this study. All recruited and consented participants will fill out a pre-survey, engage with the digital toolkit for 15 weeks, then fill out a post-survey. |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FamilyChildCare (provisional name of app)Parents will provide their child(ren) access to a smartphone, tablet, or computer for approximately 30 minutes, three times per week for 15 weeks with a total dosage of instruction of about 22.5 hours. Parents and providers will receive self-care, parenting, and parent engagement tips and resources through push notifications twice a day. Additionally, daily reminders will be sent to parents through push notification to give their child(ren) access to the learning games. After 15 weeks of app engagement, the providers and parents will be contacted by the PI to notify them of the 15 week time mark and provide the information for post-surveys via Qualtrics. | Device | Intervention |
Primary outcome
Change in Perceived Level of Stress as assessed by the Perceived Stress Scale
Time frame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Family Child Care Home Providers \& Parents: Perceived Stress Scale (PSS)-10 is a 10-item tool widely used to measure the degree to which circumstances in one's life are deemed as stressful in the general population. The PSS was designed for use in community samples with at least a junior high school education. The items are easy to understand, and the response alternatives are simple to grasp. Six items of the PSS-10 are negatively phrased (item 1, 2, 3, 6, 9, 10; negative perception subscale, while the remaining four (item 4, 5, 7 and 8; positive perception subscale) are positively phrased items and require reverse coding. Total PSS-10 score will be calculated by summing scores. A total score ranges 0-40 where a higher score indicates higher perceived stress.
Change in Perceived Level of Informational Support as assessed by the PROMIS Informational Support Short Form
Time frame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Family Child Care Home Providers \& Parents: Patient-Reported Outcomes Measurement Information System (PROMIS) Informational Support Short Form 8a assesses the perceived availability of helpful information or advice. It is an 8-item tool and each item has 5 response options ranging in values from one to five-1=Never 2=Rarely 3=Sometimes 4=Usually 5=Always with a range of 8-40. Total raw scores, sum of values to responses, will be calculated. A Score conversion table found in the Appendix of the tool will be used to translate the total raw score or pro-rated score into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.
Change in Awareness of the Maryland Early Childhood Family Engagement Framework and Toolkit as assessed by a survey question
Time frame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Family Child Care Home providers will be asked in the pre/post-surveys whether they are aware of the existence of the Maryland Early Childhood Family Engagement Framework and Toolkit- a 91-page document developed by the Maryland State Department of Education to guide child care providers in best practices for family engagement. Family Child Care Home providers will respond either i. Yes, I am aware of it but have not read it ii. Yes, I am aware of it and have read the report iii. No, I am not aware of it
Change in Social, Emotional, and Behavior Functioning in Children as assessed by the Social Competence and Behavior Evaluation for Children
Time frame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
The social, emotional, and behavioral functioning in children will be assessed by parents responding to items on the Social Competence and Behavior Evaluation for Children: The Short Form (SCBE)-30. It is a 30 item tool with a 6 point response option- Never (1), Sometimes (2 or 3), Often (4 or 5), or Always (6). The SCBE-30 has three subscales (10 items each): Anger-Aggression (cronbach's α = 0.93 in the current sample), Anxiety-Withdrawal (cronbach's α = 0.87), and Social Competence (cronbach's α = 0.89). The SCBE-30 was developed for children from ages three to six and has been shown to have high interrater and test-retest reliability and internal consistency. Sums of each subscale will be calculated.
1 secondary outcome
Change in Quality of the Parent-Child Care Relationship as assessed by the Supportive Parent-Caregiver Relationship Subscale
Time frame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucine Francis, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FamilyChildCare (provisional name of app) in people with Stress, Psychological and Child Behavior, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Level of Stress as assessed by the Perceived Stress Scale (time frame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.