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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04980365
Other study ID # IRB-2020-230
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 8, 2021
Est. completion date June 30, 2022

Study information

Verified date October 2022
Source Sam Houston State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether parents of young children (aged 10 and under) think it is feasible (in other words, doable) and acceptable (in other words, satisfactory) to use a mobile app designed to provide personalized education and enrichment for 10 minutes/day for 14 days. The investigators hope to learn if it is reasonable to ask parents to use one of three different apps and if parents are satisfied with their participation in the study. If so, the investigators can continue to study the effect of these apps on parents' stress in future research. The investigators also plan to evaluate the effect of these app-based interventions in lowering levels of stress in parents during the COVID-19 pandemic. By conducting this study, the investigators hope to learn if there are specific app-based interventions that will lead to a reduction in stress in parents, improved parental life satisfaction, and improved parent-child interactions. If the results of this study suggest these apps may be promising at reducing stress among parents, the investigators will continue doing research on these app-based interventions.


Description:

Parents will be invited to participate in a research study to see what parents of young children (aged 10 and under) think of using one of three different mobile app-based interventions to improve parental life satisfaction. The study will be conducted by Dr. Chelsea Ratcliff and Dr. Hillary Langley, Assistant Professors of Psychology at Sam Houston State University. In addition to learning about parents' satisfaction with these app-based interventions, the investigators also plan to compare the effect of these app-based interventions on levels of parental stress, and on quality of parent-child interactions during the COVID-19 pandemic. The purpose of this research is to learn if it is reasonable to ask parents to use one of three different apps and if parents are satisfied with their participation in the study. If so, the investigators can continue to study the effect of these apps. The investigators also plan to evaluate the effect of these app-based interventions in lowering levels of stress in parents. By conducting this study, the investigators hope to learn if there are specific app-based interventions that will lead to a reduction in stress in parents, improved parental life satisfaction, and improved parent-child interactions. In order to be eligible to participate, participants must be 18 years old or older, and a parent or primary caregiver of a child/children aged 10 years or young. Participants will first consent to participate by signing their name electronically using the mouse at the end of this consent form and providing their name and email address so the investigators can maintain contact. After reading this consent form and agreeing to it, participants will be directed to complete the first survey, which will take about 30 minutes to complete. They will be asked to complete two short questionnaires to determine their eligibility for the study. Participants will receive a $5 gift card for completing the first questionnaire. After completing the pre-intervention survey, participants will be randomly assigned to use one of three psychology mobile apps. The study coordinator will email them to set up a 15-minute Zoom meeting in order to provide more information about the intervention and to help download the app that they were assigned. After the 14-day period, the study coordinator will email participants a link to a 20-minute follow-up survey, and they will receive a $5 gift card for completing this survey. One month later, the study coordinator will email participants a link to the final follow-up survey, and you will receive a $10 gift card for completing this survey. Thus, participants can earn up to $20 in Amazon gift cards for participating in this study ($5 for the pre-intervention survey, $5 for the immediate post-intervention survey, and $10 for the one-month post-intervention survey).


Recruitment information / eligibility

Status Completed
Enrollment 224
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Only individuals aged 18 and older will be allowed to participate in the current research (assessed by participant self-report). 2. Individuals must identify oneself as a parent or primary caregiver of a child/children aged 10 or under (assessed by participant self-report). 3. Participants who score 30 or higher in the Parent Stress Scale (PSS) measure. 4. Participants who reside in the U.S. and can understand and answer surveys in English. Exclusion Criteria: 1. Individuals under 18 2. Non-English-speaking individuals 3. Individuals who do not consent to the survey. 4. Individuals who do not identify oneself as a parent or primary caregiver of a child/children under the age of 10 (assessed by participant self-report). 5. Individuals who score 30 or lower in the PSS measure. 6. Individuals who do not reside in the U.S.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness
Participants will be asked to use the app Mindfulness Coach daily for 10 minutes. Participants will follow app instructions for brief guided meditation sessions for 14 days.
Gratitude
Participants will be asked to use the app Grateful daily for 10 minutes. Participants will follow app instructions and will be answering to prompts related to gratitude provided by the app daily, for 10 minutes for 14 days.
Food Journal
Participants will be asked to use the app Day One daily for 10 minutes. Participants will be writing a daily journal entry describing what they ate during the previous day for 14 days.

Locations

Country Name City State
United States Sam Houston State University Huntsville Texas

Sponsors (1)

Lead Sponsor Collaborator
Sam Houston State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parental Stress Scale Total Score Parental stress will be measured with The Parental Stress Scale, an 18-item self report scale; scores range from 18-90. T1 (before intervention); T2 (immediately after intervention); T3 (1-month after intervention)
Secondary Five Facet Questionnaire: Short Form Total Score Trait mindfulness will be measured with the Five Facet Questionnaire: Short Form, a 15-item self-report scale; scores range from 15-75. T1 (before intervention); T2 (immediately after intervention); T3 (1-month after intervention)
Secondary Gratitude Questionnaire-6 Total Score Trait gratitude will be measured with the Gratitude Questionnaire-6 (GQ-6), a 6-item self-report measure that ranges from 6-42. T1 (before intervention); T2 (immediately after intervention); T3 (1-month after intervention)
Secondary Gratitude Resentment and Appreciation Test-Revised Short Form Total Score Trait gratitude will be measured with Gratitude Resentment and Appreciation Test-Revised Short Form (GRAT-R-SF), a 16-item self-report measure with scores ranging from 16-144. T1 (before intervention); T2 (immediately after intervention); T3 (1-month after intervention)
Secondary Dyadic Adjustment Scale Total Score Perceptions of one's relationship with an intimate partner will be measured via the Dyadic Adjustment Scale (DAS-7), a 7-item self-report measure with scores ranging from 0-36. T1 (before intervention); T2 (immediately after intervention); T3 (1-month after intervention)
Secondary Positive & Negative Affect Scores Positive and negative affect will be measured using the Positive and Negative Affect Schedule (PANAS), a 20-item self-report measure with PA scores ranging from 0-50 and NA scores ranging from 0-50. T1 (before intervention); T2 (immediately after intervention); T3 (1-month after intervention)
Secondary Child-Parent Relationship Scale Closeness & Conflict Scores Parents' views of their relationship with their child will be measured with the Child-Parent Relationship Scale, a 15-item self-report measure, with 7 items assessing closeness (range 7-35) and 8 items assessing conflict (range 8-40). T1 (before intervention); T2 (immediately after intervention); T3 (1-month after intervention)
Secondary Perceived Stress Scale Total Score Perceived stress will be measuring using the Perceived Stress Scale (PSS), a 10-item self-report measure with scores ranging from 0-40. T1 (before intervention); T2 (immediately after intervention); T3 (1-month after intervention)
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