- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04453657
Application prise en charge par Tele-Wellness pour les fournisseurs de services de garde d'enfants en milieu familial et les familles afin de promouvoir la santé, l'engagement familial et la préparation à l'école au milieu de la COVID-19
Adaptation et fourniture d'une boîte à outils numérique prise en charge par le télé-bien-être aux fournisseurs de services de garde d'enfants agréés de la ville de Baltimore.
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Maryland
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Baltimore, Maryland, États-Unis, 21205
- Johns Hopkins School of Nursing
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention
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. |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Perceived Level of Stress as assessed by the Perceived Stress Scale
Délai: 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. |
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
Délai: 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. |
At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
|
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Change in Awareness of the Maryland Early Childhood Family Engagement Framework and Toolkit as assessed by a survey question
Délai: 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 |
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
Délai: 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. |
At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Quality of the Parent-Child Care Relationship as assessed by the Supportive Parent-Caregiver Relationship Subscale
Délai: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
|
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) |
At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Lucine Francis, PhD, Johns Hopkins University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- Parents
- Jeunes enfants
- Parentalité
- Participation des parents
- Fournisseurs de services de garde en milieu familial
- Soins personnels multi-composants
- Service de télé-bien-être
- Stress du fournisseur de services de garde
- Soutien informationnel aux fournisseurs de services de garde d'enfants
- Comportement et fonctionnement social chez les enfants
- Jeux éducatifs d'apprentissage
- Intervention d'apprentissage précoce
- Jeux d'apprentissage socio-émotionnel
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00250864
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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