Web Application for Sibling Stress Support

Overseen By Particia F. Vadasy, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Research Behavioral Intervention Strategies, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new web app called SIBTime, designed to assist families with children who have special needs and their typically developing siblings aged 3-6. The app supports the social-emotional health of these siblings by enhancing family routines and communication. The trial compares families using the SIBTime app with those receiving standard support. Ideal participants are parents of a child with a disability and a typically developing child aged 3-6, who also have access to a smartphone or tablet and speak either English or Spanish. As an unphased trial, this study provides families with a unique opportunity to contribute to innovative solutions that could improve sibling relationships and family dynamics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the SIBTime web-application tool is safe for use?

Research has shown that the SIB-Time web app is generally safe for users. Available in two languages, the app assists families with a child who has a sibling with disabilities or health issues. As a digital tool, it involves no medical procedures or drugs, eliminating concerns about physical side effects.

To date, no reports have linked negative effects directly to the SIB-Time app. It offers strategies to aid family routines and enhance social and emotional well-being. Its primary purpose is to educate and support, not to treat medical conditions, making side effects associated with traditional medical treatments unlikely.

In summary, the SIB-Time app appears to be a safe choice for families seeking to support their typically developing children in these unique family situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SIB-Time web application because it offers a novel approach to supporting siblings experiencing stress. Unlike traditional methods that may involve in-person therapy sessions or support groups, this digital tool provides an accessible, flexible platform that families can use from the comfort of their homes. This approach leverages technology to deliver support in a convenient and user-friendly manner, making it easier for siblings to get the help they need without the barriers of travel or scheduling. The hope is that by using this innovative platform, researchers can understand how digital interventions can effectively reduce stress and improve well-being among siblings.

What evidence suggests that the SIBTime app is effective for supporting TD siblings' social-emotional health?

Research has shown that psychological support can help siblings cope with the stress of having a brother or sister with special needs. In this trial, participants in the experimental arm will use the SIB-Time web app, designed to improve the emotional health and well-being of these siblings. Early results suggest that tools like SIB-Time can also reduce stress for parents and enhance their relationships with their children. By providing parents with helpful strategies, the app supports the creation of positive family routines. This approach appears promising in meeting the unique needs of siblings in these situations. ^{2 3 5 6 7}

Who Is on the Research Team?

Jessie Marquez, BA

Principal Investigator

Oregon Research Behavioral Intervention Strategies, Inc.

Are You a Good Fit for This Trial?

This trial is for parents who have a child with a disability and another typically developing child aged between 3-6 years. Participants must own a smartphone or tablet and be able to communicate in English or Spanish.

Inclusion Criteria

I am a parent of a child with a disability and another child aged 3-6 who is developing typically.

Has a smartphone or tablet

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with the SIBTime web-based intervention for 8 weeks

8 weeks

Web-based engagement

Follow-up

Participants are monitored for changes in parenting stress, child-parent relationship, and TD sibling behavior and adjustment

1 week

Post-intervention assessment

Commercial Feasibility

Evaluation of SIBTime's acceptability and feasibility for commercial use

1 month

What Are the Treatments Tested in This Trial?

Interventions

• SIB-Time web-application tool

Trial Overview The SIBTime Phase II trial is testing the effectiveness of the SIB-Time web-application tool, designed to support siblings of children with special health needs by providing information and fostering skills for social-emotional well-being.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Sibtime web-based intervention.

Group II: Control Active Control 1 Intervention

Business as usual.

Who Is Running the Clinical Trial?

Oregon Research Behavioral Intervention Strategies, Inc.

Lead Sponsor

Trials

21

Recruited

8,600+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The web-based intervention AfterTheInjury.org (ATI) was successfully completed by all parents in the hospital, indicating its feasibility for promoting emotional recovery after pediatric injuries.

While the intervention increased parent knowledge immediately after use, it did not significantly reduce posttraumatic stress symptoms (PTSS) in parents or children at a 6-week follow-up, suggesting that additional strategies may be needed to effectively prevent psychological symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing posttraumatic stress following pediatric injury: a randomized controlled trial of a web-based psycho-educational intervention for parents. Marsac, ML., Hildenbrand, AK., Kohser, KL., et al.[2021]

A two-session psychological intervention for siblings of newly diagnosed pediatric cancer patients significantly improved their psychological well-being and medical knowledge compared to a control group receiving standard care, based on a study involving 30 siblings aged 6-17.

Despite the positive effects on well-being and knowledge, the intervention did not reduce posttraumatic stress symptoms or anxiety, indicating that while it helps with adjustment, additional support may be needed for these specific issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial. Prchal, A., Graf, A., Bergstraesser, E., et al.[2021]

Psychological interventions for siblings of pediatric cancer patients have shown significant improvements in reducing depression symptoms and enhancing medical knowledge, based on a review of 14 studies involving various intervention types.

Despite positive outcomes, the evidence is still limited and inconsistent regarding other areas like anxiety and social adjustment, highlighting the need for more rigorous randomized controlled trials in larger populations to strengthen the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological interventions with siblings of pediatric cancer patients: a systematic review. Prchal, A., Landolt, MA.[2018]

A systematic review of 102 studies on siblings of children with cancer reveals that while anxiety and depression levels are similar to peers, symptoms of cancer-related posttraumatic stress are common, indicating a significant need for targeted support.

Siblings often face academic challenges and engage in risky health behaviors as adults, highlighting the importance of interventions that enhance family communication and social support to improve their psychosocial adjustment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial functioning and risk factors among siblings of children with cancer: An updated systematic review. Long, KA., Lehmann, V., Gerhardt, CA., et al.[2022]

The study developed an electronic monitoring tool for adolescents using computerized cognitive behavioral therapy (cCBT), which allows clinicians to track mood, risk, and treatment adherence, based on feedback from 50 clinicians and 29 adolescents in focus groups.

Post-implementation feedback indicated that the e-monitoring tool did not negatively affect the therapeutic relationship, although clinicians required more time for monitoring, and there were suggestions for improving the tool's integration with existing clinical systems and enhancing privacy features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tips and Traps: Lessons From Codesigning a Clinician E-Monitoring Tool for Computerized Cognitive Behavioral Therapy. Sundram, F., Hawken, SJ., Stasiak, K., et al.[2020]

The study involved 22 siblings aged 7-18 years of children with cancer, who participated in an eight-week group intervention program called Siblings Coping Together, which provided valuable insights into their experiences and perceived changes.

The findings highlighted the benefits of group participation for siblings, suggesting that such interventions can positively impact their emotional well-being and family dynamics, and the use of visual materials in data collection is a valid approach for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emotional Experience and Perceived Changes in Siblings of Children With Cancer Reported During a Group Intervention. Neville, A., Simard, M., Hancock, K., et al.[2018]

A web-based intervention for families affected by pediatric traumatic brain injury (TBI) was found to be feasible and user-friendly, even for participants with limited computer experience, as evidenced by positive ratings from all families involved.

The program led to improved outcomes in understanding TBI and enhancing parent-child relationships, with all families expressing a willingness to recommend the intervention to others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A web-based family problem-solving intervention for families of children with traumatic brain injury. Wade, SL., Wolfe, CR., Pestian, JP.[2022]

In a study analyzing parents' perceptions, 74.5% of responses regarding siblings of children with cancer indicated negative effects, while only 1.1% reported no risk, highlighting the significant emotional burden on families.

For siblings of children with cystic fibrosis, 67.9% of parents noted negative impacts, but a notable 32.1% reported positive outcomes, suggesting that while challenges exist, there can also be beneficial aspects to these family dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric chronic illness (cancer, cystic fibrosis) effects on well siblings: parents' voices. Williams, PD., Ridder, EL., Setter, RK., et al.[2011]

The psychoeducational app significantly reduced parenting stress among users, with a reported decrease in stress levels compared to a waitlist control group, indicating its potential effectiveness in supporting parents of children with crying, sleeping, and feeding issues.

Parents using the app also gained more knowledge about their children's symptoms, suggesting that the app not only helps reduce stress but also educates parents, which could lead to better management of their children's issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Mobile-Based Intervention for Parents of Children With Crying, Sleeping, and Feeding Problems: Randomized Controlled Trial. Augustin, M., Licata-Dandel, M., Breeman, LD., et al.[2023]

A study involving 20 parents of children with cancer showed that 80% preferred Web-based data collection over traditional paper methods, indicating high acceptability and usability of the electronic instruments.

The Web-based system was found to be reliable and feasible, with no significant bias in data collection, suggesting it can be effectively used in future studies to support parents in treatment decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and usability of web-based data collection in parents of children with cancer. Pyke-Grimm, KA., Kelly, KP., Stewart, JL., et al.[2011]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06099457?cond=%22Stress,%20Psychological%22&aggFilters=status:not%20rec&rank=5

Study Details | NCT06099457 | SIBTime Phase II: Web ... Participants will complete measures pre- and post- intervention selected to detect changes in parenting stress and adjustment, parent-child relationship, ...

2. withpower.com withpower.com/trial/phase-child-family-social-emotional-health-10-2023-213fb

Web Application for Sibling Stress Support Psychological interventions have been shown to help siblings manage these challenges, suggesting that tools like the SIBTime web application could be beneficial ...

3. apps.apple.com apps.apple.com/ro/app/sibtime/id6736633734

SibTime on the App Store SibTime empowers busy parents and caregivers with strategies that work to support their young children with siblings who have disabilities or ...

4. app.trialscreen.org app.trialscreen.org/trials/family-relations-sib-time-web-application-tool-trial-nct04633473

SIB-Time Web-application Tool for Typically Developing ... This Interventional study is looking for people with Family Relations, Sibling Relations in Eugene United States to take part.

5. ori.org ori.org/project/sibtime-media-enhanced-technology-for-promoting-the-behavioral-health-and-family-relationships-of-typically-developing-young-siblings-phase-ii/

Media-enhanced Technology for Promoting the Behavioral ... The purpose of this research is to develop and test media-enhanced mobile technology that assists families in developing positive and supportive behavioral ...

6. play.google.com play.google.com/store/apps/details?id=app.web.mysibtime&hl=en_US

SibTime - Apps on Google Play SibTime is a dual-language (English/Spanish), interactive mobile app designed to support families with young kids whose siblings have disabilities or health ...

7. trialx.com trialx.com/clinical-trials/listings/259357/sibtime-phase-ii-web-application-for-typically-developing-siblings/

SIBTime Phase II: Web Application for Typically ... The aims of this proposal are to complete development and evaluation of the dual language SIBTime app, designed to build parents' and children's ...