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Early Life StressSIBTime IINCT06099457

SIBTime Phase II: Web Application for Typically Developing Siblings

A study testing SIB-Time web-application tool in people with Early Life Stress, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Early Life Stress
What is being tested?
SIB-Time web-application tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
27 Oct 2023to 20 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 1. None

Trial locations and contacts

1 site in 1 country.

United States1 site

  • David R Smith

    Springfield, Oregon, 97477

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
SIB-Time web-application tool
Keywords
Siblings, Disability, Health concern
Medical subject headings
Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIB-Time web-application toolBehavioural

    Parent-child dyads will use the SIBTime app in an 8-week intervention to test its relevance, acceptability, cultural appropriateness, and potential for efficacy.

Study groups in NCT06099457
Study groupRoleWhat they receive
TreatmentExperimentalSibtime web-based intervention.
Receives: Behavioral: SIB-Time web-application tool
ControlNo interventionBusiness as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Child-Parent Relationship Scale - Short Form

    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).

    Measured: Baseline and Week 9

  2. Parental Stress Scale

    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).

    Measured: Baseline and Week 9

  3. Self-Efficacy for Parenting Tasks Index - Toddler Scale

    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.

    Measured: Baseline and Week 9

  4. Engagement in Target Activities with Child - Frequency Subscale

    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).

    Measured: Baseline and Week 9

  5. Engagement in Program-Targeted Activities with Child - Parents' Self-Efficacy Subscale

    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).

    Measured: Baseline and Week 9

  6. Parents' Rating of their Own Program-Targeted Behaviors

    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.

    Measured: Baseline and Week 9

Secondary outcomes (7)

  1. Strengths and Difficulties Questionnaire (SDQ) -- Ages 3 to 4

    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.

    Measured: Baseline and Week 9

  2. System Usability Scale (SUS)

    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.

    Measured: Week 9 only

  3. Parent Satisfaction

    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.

    Measured: Week 9 only

  4. Family usage of the SIBTime program

    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.

    Measured: Week 9 only

  5. Commercial Feasibility

    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.

    Measured: Month 21

  6. Sibling Inventory of Behavior

    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.

    Measured: Baseline and Week 9

  7. Parent's Rating of Their Child's Program-Targeted Behaviors

    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.

    Measured: Baseline and Week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2023
  2. Study start27 Oct 2023
  3. Primary completion2 Feb 2026
  4. Study completion20 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
One intervention and two arms (intervention and waitlist control group, treatment-as-usual). Randomly assign 80 parent participants to a treatment condition and 80 to waitlist control group, treatment-as-usual. Conduct an 8-week intervention among the treatment condition participants. At the conclusion of post-intervention testing, deliver the SIBTime intervention to the treatment-as-usual condition participants.
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06099457
Sponsor's protocol ID
MD015947-02
Other IDs
2R44MD015947-02
Acronym
SIBTime II
Status last verified
May 2026
First submitted
19 Oct 2023
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Driscoll, K., & Pianta, R. C. (2011). Mothers' and fathers' perceptions of conflict and closeness in parent-child relationships during early childhood. Journal of Early Childhood and Infant Psychology, 7, 1-24.

  • Berry, J. O., & Jones, W. H. (1995). The Parental Stress Scale: Initial psychometric evidence. Journal of Social and Personal Relationship, 12(3), 463-472.

  • Louie, A. D., Cromer, L. D., & Berry, J. O. (2017). Assessing parenting stress: Review of the use and interpretation of the Parental Stress Scale. The Family Journal, 25(4), 359-367.

  • Zelman, J. J. & Ferro, M. A. (2018). The Parental Stress Scale: Psychometric properties in families of children with chronic health conditions. Family Relations, 67(2), 240-252.

  • Coleman, P. K. & Karraker, K. H. (2003). Maternal self-efficacy beliefs, competence in parenting, and toddlers' behavior and developmental status. Infant Mental Health Journal, 24(2), 126-148.

  • Lobato DJ, Kao BT. Integrated sibling-parent group intervention to improve sibling knowledge and adjustment to chronic illness and disability. J Pediatr Psychol. 2002 Dec;27(8):711-6. doi: 10.1093/jpepsy/27.8.711.

    PubMed 12403861

  • Sahler OJ, Carpenter PJ. Evaluation of a camp program for siblings of children with cancer. Am J Dis Child. 1989 Jun;143(6):690-6. doi: 10.1001/archpedi.1989.02150180068023.

    PubMed 2729214

  • Guite, J., Lobato, D., Kao, B, & Plante, W. (2010). Discordance between sibling and parent reports of the impact of chronic illness and disability on siblings. Children's Health Care, 33(1), 77-92.

  • Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.

    PubMed 9255702

  • Brooke, J. (1996). SUS: A "quick and dirty" usability scale. In P. W. Jordan, B. Thomas, B. A. Weerdmeester, & A. L. McClelland (Eds.), Usability evaluation in industry. Taylor and Francis.

  • Sauro J. (2011). A practical guide to the System Usability Scale: Background, benchmarks & best practices. Measuring Usability LLC.

Questions about this trial

What is this clinical trial studying?

A study testing SIB-Time web-application tool in people with Early Life Stress, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child-Parent Relationship Scale - Short Form (time frame: Baseline and Week 9). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06099457, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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