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

Trial Summary

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 data supports the effectiveness of the SIBTime web application treatment for sibling stress support?

Research shows that siblings of children with cancer or cystic fibrosis often face emotional and social challenges, highlighting the need for supportive interventions. Psychological interventions have been shown to help siblings manage these challenges, suggesting that tools like the SIBTime web application could be beneficial in providing support. ^{1 2 3 4 5}

How is the Web Application for Sibling Stress Support different from other treatments for sibling stress?

The Web Application for Sibling Stress Support is unique because it uses a web-based platform to provide support, which can be more accessible and convenient compared to traditional face-to-face therapy. This approach is similar to other web-based interventions that have been successful in providing psychoeducational support and improving family dynamics, as seen in interventions for traumatic brain injury and post-injury stress. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Jessie Marquez, BA

Principal Investigator

Oregon Research Behavioral Intervention Strategies, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Pediatric chronic illness (cancer, cystic fibrosis) effects on well siblings: parents' voices. [2011]

2. England pubmed.ncbi.nlm.nih.gov

A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Psychological interventions with siblings of pediatric cancer patients: a systematic review. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

The Emotional Experience and Perceived Changes in Siblings of Children With Cancer Reported During a Group Intervention. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Psychosocial functioning and risk factors among siblings of children with cancer: An updated systematic review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A web-based family problem-solving intervention for families of children with traumatic brain injury. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Preventing posttraumatic stress following pediatric injury: a randomized controlled trial of a web-based psycho-educational intervention for parents. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

Effects of a Mobile-Based Intervention for Parents of Children With Crying, Sleeping, and Feeding Problems: Randomized Controlled Trial. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Tips and Traps: Lessons From Codesigning a Clinician E-Monitoring Tool for Computerized Cognitive Behavioral Therapy. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and usability of web-based data collection in parents of children with cancer. [2011]