NCT04980365

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 19, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

July 19, 2021

Last Update Submit

October 24, 2022

Conditions

Keywords

Parental stressHealth PsychologyMental health appsMindfulnessGratitude

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Five Facet Questionnaire: Short Form Total Score

    T1 (before intervention); T2 (immediately after intervention); T3 (1-month after intervention)

  • Gratitude Questionnaire-6 Total Score

    T1 (before intervention); T2 (immediately after intervention); T3 (1-month after intervention)

  • Gratitude Resentment and Appreciation Test-Revised Short Form Total Score

    T1 (before intervention); T2 (immediately after intervention); T3 (1-month after intervention)

  • Dyadic Adjustment Scale Total Score

    T1 (before intervention); T2 (immediately after intervention); T3 (1-month after intervention)

  • Positive & Negative Affect Scores

    T1 (before intervention); T2 (immediately after intervention); T3 (1-month after intervention)

  • +2 more secondary outcomes

Study Arms (3)

Mindfulness

EXPERIMENTAL

Participants will be asked to use the app Mindfulness Coach 10 minutes for 14 days.

Behavioral: Mindfulness

Gratitude

EXPERIMENTAL

Participants will be asked to use the app Grateful 10 minutes for 14 days.

Behavioral: Gratitude

Control

ACTIVE COMPARATOR

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.

Behavioral: Food Journal

Interventions

MindfulnessBEHAVIORAL

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.

Mindfulness
GratitudeBEHAVIORAL

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.

Gratitude
Food JournalBEHAVIORAL

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Only individuals aged 18 and older will be allowed to participate in the current research (assessed by participant self-report).
  • Individuals must identify oneself as a parent or primary caregiver of a child/children aged 10 or under (assessed by participant self-report).
  • Participants who score 30 or higher in the Parent Stress Scale (PSS) measure.
  • Participants who reside in the U.S. and can understand and answer surveys in English.

You may not qualify if:

  • Individuals under 18
  • Non-English-speaking individuals
  • Individuals who do not consent to the survey.
  • 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).
  • Individuals who score 30 or lower in the PSS measure.
  • Individuals who do not reside in the U.S.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sam Houston State University

Huntsville, Texas, 77341, United States

Location

Related Publications (1)

  • Ratcliff CG, Langley HA, Torres D, Anderson KS. Randomized controlled trial of brief app-based gratitude and mindfulness interventions for parents of young children. J Fam Psychol. 2025 Sep;39(6):848-860. doi: 10.1037/fam0001347. Epub 2025 Jun 9.

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Chelsea G Ratcliff, Ph.D.

    Sam Houston State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will have knowledge of the intervention they will receive but will have no knowledge of the other interventions used in the study.
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: Potential participants will be provided access to an informed consent form and baseline survey via Qualtrics. After baseline is completed and eligibility confirmed, the study coordinator will randomly assign the participant to one of three app-based intervention conditions: Gratitude, Mindfulness, or control group. Next, the study coordinator will email them to schedule a Zoom meeting. The meeting will last 15 minutes and participants will be informed of what app they will use. After a 14-day period, the study coordinator will send participants a follow-up survey, and a final follow-up Qualtrics survey one month after the intervention ends. Participants will receive $5 for completing the baseline questionnaire, $5 for the immediate post-survey, and $10 for the one-month follow-up survey (participants can receive up to $20). Participants recruited via PeRP will receive one credit for completing the baseline questionnaire, two for the post-survey, and one for the follow-up.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 19, 2021

First Posted

July 28, 2021

Study Start

June 8, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

At this time, there is no plan to share individual participant data with other researchers.

Locations