Clinical trial NCT04633473: SIB-Time Web-application Tool for Typically Developing Siblings
Official title: SIBTime: Media-enhanced Technology for Promoting the Behavioral Health and Family Relationships of Typically Developing Young Siblings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Relations
Sibling Relations
Keywords: Social Emotional Health
Lead sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Oregon Research Institute
First posted: 2020-11-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In the United States, over 32.7 million people have special health, developmental, and mental health concerns. Most of these people have typically developing brothers and sisters. Across the lifespan, siblings share high levels of involvement in each other's lives, and also many of the concerns that parents of children with special needs experience, including isolation, a need for information, concerns about the future, and caregiving demands. Brothers and sisters also face issues that are uniquely theirs including emotions (resentment, worry, embarrassment, guilt), peer issues, and family communication challenges. The team of researchers, developers, and consultants built and tested an assistive media enhanced web-application tool for developing knowledge, skills, and routines for attending to TD siblings' (ages 3-5) social-emotional health and well-being.

Detailed description: The investigators conducted a 4-week intervention to assess the English/Spanish, media-enhanced SIBTime web-application tool in terms of its relevance, acceptability, cultural appropriateness, and potential for efficacy to deliver a family-based intervention. The test used a within subjects pre-post design to detect changes in parent self-efficacy, family cohesion, and knowledge, and parent rating of sibling-parent relationship. Additionally, the investigators collected a post-test evaluation of consumer satisfaction and recommendations for modifications to the program.

Eligibility criteria: Inclusion Criteria

* Be the primary parent/guardian of a child with a disability
* Also be the primary parent/guardian of a typically developing child, 3-5 years old
* Speak English or Spanish
* Have access to a computer, tablet, or smartphone

Exclusion Criteria

• N/A

Primary outcomes:
measure: Parenting & Family Adjustment Scales (PAFAS) Parent/Child Relationship Subscale
timeFrame: Enrollment, and at 4 weeks (after treatment completion)
measure: Parenting & Family Adjustment Scales (PAFAS) Parental Adjustment Subscale
timeFrame: Enrollment, and at 4 weeks (after treatment completion)
measure: Parenting & Family Adjustment Scales (PAFAS) Family Relationships Subscale
timeFrame: Enrollment, and at 4 weeks (after treatment completion)
measure: Self-Efficacy for Parenting Tasks Index (SEPTI) Emotional Availability Subscale
timeFrame: Enrollment, and at 4 weeks (after treatment completion)
measure: Self-Efficacy for Parenting Tasks Index (SEPTI) Nurturance/Valuing/Empathic Responsiveness Subscale
timeFrame: Enrollment, and at 4 weeks (after treatment completion)
measure: Self-Efficacy for Parenting Tasks Index (SEPTI) Play Subscale
timeFrame: Enrollment, and at 4 weeks (after treatment completion)
measure: Self-Efficacy for Parenting Tasks Index (SEPTI) Teaching Subscale
timeFrame: Enrollment, and at 4 weeks (after treatment completion)
measure: System Usability Scale (SUS)
timeFrame: Week 4
Secondary outcomes:
measure: Engagement in Target Activities With Child - Frequency
timeFrame: Enrollment, and at 4 weeks (after treatment completion)
measure: Engagement in Target Activities With Child - Self-efficacy
timeFrame: Enrollment, and at 4 weeks (after treatment completion)
measure: Family Usage of the SIBTime App - Number of Sessions
timeFrame: At 4 weeks (after treatment completion)
measure: Family Usage of the SIBTime App - Program Exposure
timeFrame: At 4 weeks (after treatment completion)
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Behavioral Intervention Strategies, Inc.
state: Oregon
Study officials:
affiliation: Oregon Research Behavioral Interventions Strategies, Inc.
name: Patricia Vadasy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: