SIBTime Phase II: Web Application for Typically Developing Siblings

NCT ID: NCT06099457

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-27

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Early Life Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Sibtime web-based intervention.

Group Type EXPERIMENTAL

SIB-Time web-application tool

Intervention Type BEHAVIORAL

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

Control

Business as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Oregon Research Behavioral Intervention Strategies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessie Marquez, BA

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Behavioral Intervention Strategies, Inc.

Locations

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David R Smith

Springfield, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessie Marquez, BA

Role: CONTACT

541-484-2123

Particia F. Vadasy, PhD

Role: CONTACT

541-484-2123

Facility Contacts

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David R Smith, PhD

Role: primary

541-484-2123

References

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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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 12403861 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2729214 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 9255702 (View on PubMed)

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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Other Identifiers

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2R44MD015947-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MD015947-02

Identifier Type: -

Identifier Source: org_study_id

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