SIBTime Phase II: Web Application for Typically Developing Siblings (SIBTime II)

May 29, 2026 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

Most of the over 32.7 million people in the U.S. who have special health, developmental, and mental health concerns have typically developing (TD) brothers and sisters who share high levels of involvement in their sibling's lives. Disability and health agencies lack effective tools to support the information and support needs of TD siblings and their families, in particular for ethnic minority and rural families. The aims of this proposal are to complete development and evaluation of the dual language SIBTime app, designed to build parents' and children's knowledge, skills, and engaging family routines to nurture TD siblings' (ages 3-6) 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

An 8-week RCT will be conducted to evaluate the full-scale SIBTime program in a sufficiently powered randomized controlled trial evaluation (sample size = 160 parent/child dyads). SIBTime will be assessed in terms of its relevance, acceptability, cultural appropriateness, and efficacy. Participants will complete measures pre- and post- intervention selected to detect changes in parenting stress and adjustment, parent-child relationship, parents' self-efficacy and frequency of engagement in the targeted parenting strategies, and TD sibling behavior and adjustment. Information will also be collected on family demographics, consumer satisfaction, usability ratings, usage metrics, 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.
39

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Springfield, Oregon, United States, 97477
        • David R Smith

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Criteria:

Inclusion criteria:

  1. Parent of a child with a disability and a typically developing child aged 3-6
  2. Has a smartphone or tablet
  3. Speaks English or Spanish

Exclusion criteria:

1. None

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: Randomized
  • Interventional Model: Parallel 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.
No Intervention: Control
Business as usual.
Experimental: Treatment
Sibtime web-based intervention.
Behavioral: SIB-Time web-application tool
Parent-child dyads will use the SIBTime app in an 8-week intervention to test its relevance, acceptability, cultural appropriateness, and potential for efficacy.

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
Child-Parent Relationship Scale - Short Form
Time Frame: Baseline and Week 9
The Child-Parent Relationship Scale - Short Form (CPRS-SF; Driscoll & Pianta, 2011) is used to measure the degree of closeness and conflict in the parent-child relationship. The CPRS-SF is comprised of 15 parent-report items that ask the parent for their assessment of the child-parent relationship, the child's emotional stance toward the parent, and the parent's feelings toward the child. Items are answered on a 5-point "Definitely does not apply" to "Definitely applies" scale. Two subscales are derived: Conflicts and Positive Aspects/Closeness. Both subscales are measured by 7 items, which are averaged together; average scores range from 1 to 5. For the Conflicts subscale, higher scores indicate worse outcomes; for the Closeness subscale, higher scores indicate better outcomes. The CPRS-SF has been validated with parents of preschoolers and first graders, and shows good internal consistency with acceptable Cronbach alphas (.64-.84).
Baseline and Week 9
Parental Stress Scale
Time Frame: Baseline and Week 9
The Parental Stress Scale (PSS; Berry and Jones, 1995) is used to measure parents' stress level. The PSS is comprised of 18 items that ask about positive (emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood. Respondents answer on a 5-point Likert "Strongly agree" to "Strongly disagree" scale in terms of their typical relationship with their child(ren). Summed scores range from 18 to 90, with higher scores indicating worse outcomes. The PSS shows good internal consistency, test-retest reliability, discriminant validity, and construct validity (Berry & Jones, 1995). It has been validated across cultures and languages (Louie, Cromer, & Berry, 2017), with families of TD children, and with families of children with emotional/ behavioral problems, developmental disabilities (Berry & Jones, 1995), and chronic health conditions (Zelman & Ferro, 2018).
Baseline and Week 9
Self-Efficacy for Parenting Tasks Index - Toddler Scale
Time Frame: Baseline and Week 9
The Self-Efficacy for Parenting Tasks Index - Toddler Scale (SEPTI-TS; Coleman & Karraker, 2003) is used to measure parents' self-efficacy for a broad range of parenting tasks involved in ensuring the wellbeing of the target TD child. Four subscales of the SEPTI will be used: Emotional Availability (7 items), Nurturance/Valuing/ Empathetic Responsiveness (8 items), Play (7 items), and Teaching (9 items). Items are answered on a 6-point Likert response scale (1= Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating lower self-efficacy (worse outcome). The SEPTI-TS shows good internal consistency, construct validity, discriminant validity, and sensitivity to change.
Baseline and Week 9
Engagement in Target Activities with Child - Frequency Subscale
Time Frame: Baseline and Week 9
The frequency of parents' engagement in the parenting practices targeted by the intervention is measured via the Engagement in Target Activities with Child measure, Frequency subscale. Created for this study, these 22 items ask parents to report the frequency with which they have engaged in target parenting practices in the past month; parents report their frequency on a 7-point scale ("Never in the past month" to "6 or more times per day"). Averaged scores range from 0 to 6, with higher scores indicating more frequent parental engagement in the target activities (better outcome).
Baseline and Week 9
Engagement in Program-Targeted Activities with Child - Parents' Self-Efficacy Subscale
Time Frame: Baseline and Week 9
Parents' self-efficacy for engaging in the parenting practices targeted by the intervention is measured via the Engagement in Target Activities with Child measure, Parents' Self-Efficacy subscale. Created for this study, these 22 items ask parents to rate how confident they are that they know how to do a series of parenting practices targeted by the program, on a scale of 0 to 4 (0 = I don't know how to do this at all, 4 = I know how to do this very well). Averaged scores range from 0 to 4, with higher scores indicating greater parental self-efficacy that they know how to do the target activities (better outcome).
Baseline and Week 9
Parents' Rating of their Own Program-Targeted Behaviors
Time Frame: Baseline and Week 9
Parents' perception of their TD child's engagement in program-targeted behaviors is measured with parents' rating on 4 child behaviors targeted by the program, and one item asking about the child's general adjustment to their sibling's disability/illness. Created for this study, 4 of the items ask parents to report the frequency with which their TD child has engaged in target behaviors in the past month; parents report their frequency on a 7-point scale ("Never in the past month" to "6 or more times per day"). Averaged scores range from 0 to 6, with higher scores indicating more frequent child engagement in the target activities (better outcome). The 5th item asks parents how satisfied they are with how well their TD child is doing, as a sibling of a child with a disability or health concern. Parents respond on a scale of 1 to 10, with 1 = Not at all satisfied and 10 = Very satisfied.
Baseline and Week 9

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
Commercial Feasibility
Time Frame: Month 21
Commercial feasibility will be measured with the Practitioner Satisfaction & Program Acceptability measure, 20 items that Advisory Board members and recruitment partners will complete. These items measure SIBTime's acceptability for the target families these practitioners serve, feasibility for use among agencies, and interest in purchasing and adopting SIBTime.
Month 21
Strengths and Difficulties Questionnaire (SDQ) -- Ages 3 to 4
Time Frame: Baseline and Week 9
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) is used to measure the TD child's overall adjustment. The SDQ is a brief, valid, reliable, and commonly used parent-report questionnaire about child behavior that can be completed in about 5 minutes. The instrument includes 25 items that assess child challenging behaviors (emotional symptoms, conduct problems, hyperactivity/inattention), peer relationships, and prosocial behavior. Respondents answer on a 3-point (from 0 to 2) "Not true" to "Certainly true" scale. For problem behavior subscales, higher scores indicate worse adjustment; for the prosocial behavior scale, higher scores indicate better adjustment. The SDQ shows good construct and discriminant validity and is sensitive to both child internalizing and externalizing behavior.
Baseline and Week 9
System Usability Scale (SUS)
Time Frame: Week 9 only
Skill usability is measured with the System Usability Scale (SUS), a commonly used 10-item scale that measures subjective perceptions of usability. Items are answered on a 5-point scale (0=Strongly disagree; 4=Strongly agree); scores on the scale are summed and multiplied by 2.5, such that they range from 0 to 100, with higher scores indicating better usability. The SUS has been normed, and scoring produces an overall usability "grade" (Brooke, 1996; Sauro, 2011). This measure is obtained from only from treatment participants only at post-test.
Week 9 only
Parent Satisfaction
Time Frame: Week 9 only
Parents' satisfaction with the SibTime app will be measured with 9 items that ask parents to rate, on a 5-point response scale (e.g. 1=Not at all; 5=Very much), the degree to which the SibTime app was helpful to them and to their child, addressed topics important to their family, enjoyable, and their overall satisfaction with the SibTime app. Scores are averaged across items, with higher scores indicating greater satisfaction (better outcomes). This measure will be obtained only from treatment participants only at posttest.
Week 9 only
Family usage of the SIBTime program
Time Frame: Week 9 only
Families' usage of the SIBTime app is measured through usage metrics collected on the back-end database, including whether or not the app is activated, which elements are accessed; frequency and duration of engagements; and points of difficulty or failure. These metrics are collected from users in the treatment condition only.
Week 9 only
Sibling Inventory of Behavior
Time Frame: Baseline and Week 9
The parent's perceptions of their children's sibling relationship is measured with the Sibling Inventory of Behavior. The instrument (SIB; Schaeffer & Edgerton, 1981; Volling & Blandon, 2003) has 6 subscales: Companionship/Involvement, Empathy/Concern, Teach/Manage/Directiveness, Rivalry, Aggression/Conflict, and Avoidance. The Teach/Mange/Directiveness subscale was not used, and the number of items in the Rivalry scale was reduced from 7 to 5 to reduce length and participant burden. Parents answer on a 5-point Never to Always scale. Average scores range from 1 to 5. For Positive subscales (Companionship/Involvement and Empathy/Concern), higher scores indicate a better relationship; for Negative subscales (Rivalry, Aggression/Conflict, and Avoidance), higher score indicate a worse relationship. Scores can be analyzed at the subscale level, as well as at the composite "Positive" and "Negative" levels.
Baseline and Week 9
Parent's Rating of Their Child's Program-Targeted Behaviors
Time Frame: Baseline and Week 9
Parents' perception of their TD child's engagement in program-targeted behaviors is measured with parents' rating on 4 child behaviors targeted by the program, and one item asking about the child's general adjustment to their sibling's disability/illness. Created for this study, 4 of the items ask parents to report the frequency with which their TD child has engaged in target behaviors in the past month; parents report their frequency on a 7-point scale ("Never in the past month" to "6 or more times per day"). Averaged scores range from 0 to 6, with higher scores indicating more frequent child engagement in the target activities (better outcome). The 5th item asks parents how satisfied they are with how well their TD child is doing, as a sibling of a child with a disability or health concern. Parents respond on a scale of 1 to 10, with 1 = Not at all satisfied and 10 = Very satisfied.
Baseline and Week 9

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.
National Institute on Minority Health and Health Disparities (NIMHD)

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: Jessie Marquez, BA, Oregon Research Behavioral Intervention Strategies, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
October 27, 2023

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.
February 2, 2026

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.
May 20, 2026

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 19, 2023

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.
October 19, 2023

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.
October 25, 2023

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.
June 2, 2026

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.
May 29, 2026

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.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • MD015947-02
  • 2R44MD015947-02 (U.S. NIH Grant/Contract)

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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