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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Oregon Research Behavioral Intervention Strategies, Inc.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Behavioral: SIB-Time Web-Application Tool
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:
  • SIBTime

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Enrollment, and at 4 weeks (after treatment completion)
Parenting & Family Adjustment Scales (PAFAS) Parental Adjustment 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.
Enrollment, and at 4 weeks (after treatment completion)
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.
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)
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.
Enrollment, and at 4 weeks (after treatment completion)
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.
Enrollment, and at 4 weeks (after treatment completion)
Self-Efficacy for Parenting Tasks Index (SEPTI) Play Subscale
Time Frame: Enrollment, and at 4 weeks (after treatment completion)
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.
Enrollment, and at 4 weeks (after treatment completion)
Self-Efficacy for Parenting Tasks Index (SEPTI) Teaching Subscale
Time Frame: Enrollment, and at 4 weeks (after treatment completion)
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.
Enrollment, and at 4 weeks (after treatment completion)
System Usability Scale (SUS)
Time Frame: Week 4
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.
Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Engagement in Target Activities With Child - Frequency
Time Frame: Enrollment, and at 4 weeks (after treatment completion)
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.
Enrollment, and at 4 weeks (after treatment completion)
Engagement in Target Activities With Child - Self-efficacy
Time Frame: Enrollment, and at 4 weeks (after treatment completion)
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.
Enrollment, and at 4 weeks (after treatment completion)
Family Usage of the SIBTime App - Number of Sessions
Time Frame: At 4 weeks (after treatment completion)
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.
At 4 weeks (after treatment completion)
Family Usage of the SIBTime App - Program Exposure
Time Frame: At 4 weeks (after treatment completion)
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.
At 4 weeks (after treatment completion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Research Behavioral Intervention Strategies, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Oregon Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings