- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04633473
SIB-Time Web-application Tool for Typically Developing Siblings (SIBTime)
January 22, 2024 updated by: Oregon Research Behavioral Intervention Strategies, Inc.
SIBTime: Media-enhanced Technology for Promoting the Behavioral Health and Family Relationships of Typically Developing Young Siblings
In the United States, over 32.7 million people have special health, developmental, and mental health concerns.
Most of these people have typically developing brothers and sisters.
Across the lifespan, siblings share high levels of involvement in each other's lives, and also many of the concerns that parents of children with special needs experience, including isolation, a need for information, concerns about the future, and caregiving demands.
Brothers and sisters also face issues that are uniquely theirs including emotions (resentment, worry, embarrassment, guilt), peer issues, and family communication challenges.
The team of researchers, developers, and consultants built and tested an assistive media enhanced web-application tool for developing knowledge, skills, and routines for attending to TD siblings' (ages 3-5) social-emotional health and well-being.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators conducted a 4-week intervention to assess the English/Spanish, media-enhanced SIBTime web-application tool in terms of its relevance, acceptability, cultural appropriateness, and potential for efficacy to deliver a family-based intervention.
The test used a within subjects pre-post design to detect changes in parent self-efficacy, family cohesion, and knowledge, and parent rating of sibling-parent relationship.
Additionally, the investigators collected a post-test evaluation of consumer satisfaction and recommendations for modifications to the program.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Oregon
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Eugene, Oregon, United States, 97403
- Oregon Research Behavioral Intervention Strategies, Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria
- Be the primary parent/guardian of a child with a disability
- Also be the primary parent/guardian of a typically developing child, 3-5 years old
- Speak English or Spanish
- Have access to a computer, tablet, or smartphone
Exclusion Criteria
• N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SIBTime
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
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Parents used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents.
During the 4-week intervention period, parents used the app at their convenience.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parenting & Family Adjustment Scales (PAFAS) Parent/Child Relationship Subscale
Time Frame: Enrollment, and at 4 weeks (after treatment completion)
|
The Parenting & Family Adjustment Scales (PAFAS; Sanders et al., 2014) Parent/Child Relationship subscale measures the quality of the parent-child relationship, asking how true various statements have been over the past 4 weeks.
The Parent/Child Relationship subscale is measured with 5 items, answered on a 5-point scale (0=Not at all; 4=Very much).
Average scores range from 0 to 4, with higher scores indicating worse outcomes.
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Enrollment, and at 4 weeks (after treatment completion)
|
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Parenting & Family Adjustment Scales (PAFAS) Parental Adjustment Subscale
Time Frame: Enrollment, and at 4 weeks (after treatment completion)
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The Parenting & Family Adjustment Scales (PAFAS; Sanders et al., 2014) measures change in parenting practices, family cohesion, parent-child relationship quality, and parents' stress.
The 30 items on the PAFAS sort into 7 subscales: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner.
Items are rated on a 5-point scale (0-4) with higher scores worse.
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Enrollment, and at 4 weeks (after treatment completion)
|
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Parenting & Family Adjustment Scales (PAFAS) Family Relationships Subscale
Time Frame: Enrollment, and at 4 weeks (after treatment completion)
|
The Parenting & Family Adjustment Scales (PAFAS; Sanders et al., 2014) measures change in parenting practices, family cohesion, parent-child relationship quality, and parents' stress.
The 30 items on the PAFAS sort into 7 subscales: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner.
Items are rated on a 5-point scale (0-4) with higher scores worse.
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Enrollment, and at 4 weeks (after treatment completion)
|
|
Self-Efficacy for Parenting Tasks Index (SEPTI) Emotional Availability Subscale
Time Frame: Enrollment, and at 4 weeks (after treatment completion)
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The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman & Karraker, 2000) - Emotional Availability subscale measures parents' self-efficacy for providing emotional support to their typically developing child and meeting their child's emotional needs.
Parents rate their agreement or disagreement with a series of statements.
The SEPTI Emotional Availability subscale is measured with 7 items.
Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
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Enrollment, and at 4 weeks (after treatment completion)
|
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Self-Efficacy for Parenting Tasks Index (SEPTI) Nurturance/Valuing/Empathic Responsiveness Subscale
Time Frame: Enrollment, and at 4 weeks (after treatment completion)
|
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman & Karraker, 2000) - Nurturance/Valuing/Empathic Responsiveness subscale measures parents' self-efficacy for providing empathy, nurturance, and understanding to their typically developing child.
Parents rate their agreement or disagreement with a series of statements.
The SEPTI Nurturance/Valuing/Empathic Responsiveness subscale is measured with 8 items.
Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
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Enrollment, and at 4 weeks (after treatment completion)
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Self-Efficacy for Parenting Tasks Index (SEPTI) Play Subscale
Time Frame: Enrollment, and at 4 weeks (after treatment completion)
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The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman & Karraker, 2000) - Play subscale measures parents' self-efficacy for playing with and having fun with their typically developing child.
Parents rate their agreement or disagreement with a series of statements.
The SEPTI Play subscale is measured with 7 items.
Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
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Enrollment, and at 4 weeks (after treatment completion)
|
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Self-Efficacy for Parenting Tasks Index (SEPTI) Teaching Subscale
Time Frame: Enrollment, and at 4 weeks (after treatment completion)
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The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman & Karraker, 2000) - Teaching subscale measures parents' self-efficacy for explaining things and teaching their typically developing child about the world in a way that their child can understand.
Parents rate their agreement or disagreement with a series of statements.
The SEPTI Teaching subscale is measured with 9 items.
Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
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Enrollment, and at 4 weeks (after treatment completion)
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System Usability Scale (SUS)
Time Frame: Week 4
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The System Usability Scale (SUS) is a commonly used 10-item measure (with a 5-point scale) of subjective perceptions of technology usability.
To calculate the total SUS score, the responses to all 10 SUS questions are re-scaled and/or re-scored in a way that all items had values from zero to 4 with 4 being the most positive.
These converted scores are added and then multiplied by 2.5 to convert the range of possible values 0-100 (instead of from 0 to 40).
Higher scores are better.
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Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Engagement in Target Activities With Child - Frequency
Time Frame: Enrollment, and at 4 weeks (after treatment completion)
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The Engagement in Target Activities with Child - Frequency subscale measures the frequency with which parents report engaging in specific "connection routine" activities with their typically developing child in the past month, across 17 items reflecting a range of program-targeted parenting behaviors.
Respondents answer on a 7-point frequency scale (0=Never in the past month; 6=6 or more times per day); average scores range from 0 to 6, with higher scores indicating better outcomes.
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Enrollment, and at 4 weeks (after treatment completion)
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Engagement in Target Activities With Child - Self-efficacy
Time Frame: Enrollment, and at 4 weeks (after treatment completion)
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The Engagement in Target Activities with Child - Self-Efficacy subscale measures parents' self-efficacy for engaging in specific "connection routine" activities with their typically developing child in the past month, across 17 items reflecting a range of program-targeted parenting behaviors.
Respondents answer on a 10-point scale of how confident they are that they can carry out these behaviors (1=Not at all confident; 10=Highly confident); average scores range from 1 to 10, with higher scores indicating better outcomes.
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Enrollment, and at 4 weeks (after treatment completion)
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Family Usage of the SIBTime App - Number of Sessions
Time Frame: At 4 weeks (after treatment completion)
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Measure the families' usage of the SIBTime app using metrics and transcripts collected on the back-end database, including activation of the app; which elements are accessed; frequency, timing, and duration of engagements; and points of difficulty or failure.
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At 4 weeks (after treatment completion)
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Family Usage of the SIBTime App - Program Exposure
Time Frame: At 4 weeks (after treatment completion)
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Measure the families' usage of the SIBTime app using metrics and transcripts collected on the back-end database, including activation of the app; which elements are accessed; frequency, timing, and duration of engagements; and points of difficulty or failure.
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At 4 weeks (after treatment completion)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Patricia Vadasy, Ph.D., Oregon Research Behavioral Interventions Strategies, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2021
Primary Completion (Actual)
March 30, 2022
Study Completion (Actual)
March 30, 2022
Study Registration Dates
First Submitted
October 28, 2020
First Submitted That Met QC Criteria
November 12, 2020
First Posted (Actual)
November 18, 2020
Study Record Updates
Last Update Posted (Actual)
July 5, 2024
Last Update Submitted That Met QC Criteria
January 22, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MD015947
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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