SIB-Time Web-application Tool for Typically Developing Siblings

NCT04633473 | Completed Results

• 1 other identifier: MD015947
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Family Relations; Sibling Relations

Keywords

Social Emotional Health

Outcome Measures

Primary Outcomes (8)

• Parenting & Family Adjustment Scales (PAFAS) Parent/Child Relationship Subscale

  The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) Parent/Child Relationship subscale measures the quality of the parent-child relationship, asking how true various statements have been over the past 4 weeks. The Parent/Child Relationship subscale is measured with 5 items, answered on a 5-point scale (0=Not at all; 4=Very much). Average scores range from 0 to 4, with higher scores indicating worse outcomes.

  Enrollment, and at 4 weeks (after treatment completion)

• Parenting & Family Adjustment Scales (PAFAS) Parental Adjustment Subscale

  The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) measures change in parenting practices, family cohesion, parent-child relationship quality, and parents' stress. The 30 items on the PAFAS sort into 7 subscales: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner. Items are rated on a 5-point scale (0-4) with higher scores worse.

  Enrollment, and at 4 weeks (after treatment completion)

• Parenting & Family Adjustment Scales (PAFAS) Family Relationships Subscale

  The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) measures change in parenting practices, family cohesion, parent-child relationship quality, and parents' stress. The 30 items on the PAFAS sort into 7 subscales: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner. Items are rated on a 5-point scale (0-4) with higher scores worse.

  Enrollment, and at 4 weeks (after treatment completion)

• Self-Efficacy for Parenting Tasks Index (SEPTI) Emotional Availability Subscale

  The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Emotional Availability subscale measures parents' self-efficacy for providing emotional support to their typically developing child and meeting their child's emotional needs. Parents rate their agreement or disagreement with a series of statements. The SEPTI Emotional Availability subscale is measured with 7 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.

  Enrollment, and at 4 weeks (after treatment completion)

• Self-Efficacy for Parenting Tasks Index (SEPTI) Nurturance/Valuing/Empathic Responsiveness Subscale

  The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Nurturance/Valuing/Empathic Responsiveness subscale measures parents' self-efficacy for providing empathy, nurturance, and understanding to their typically developing child. Parents rate their agreement or disagreement with a series of statements. The SEPTI Nurturance/Valuing/Empathic Responsiveness subscale is measured with 8 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.

  Enrollment, and at 4 weeks (after treatment completion)

• Self-Efficacy for Parenting Tasks Index (SEPTI) Play Subscale

  The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Play subscale measures parents' self-efficacy for playing with and having fun with their typically developing child. Parents rate their agreement or disagreement with a series of statements. The SEPTI Play subscale is measured with 7 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.

  Enrollment, and at 4 weeks (after treatment completion)

• Self-Efficacy for Parenting Tasks Index (SEPTI) Teaching Subscale

  The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Teaching subscale measures parents' self-efficacy for explaining things and teaching their typically developing child about the world in a way that their child can understand. Parents rate their agreement or disagreement with a series of statements. The SEPTI Teaching subscale is measured with 9 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.

  Enrollment, and at 4 weeks (after treatment completion)

• System Usability Scale (SUS)

  The System Usability Scale (SUS) is a commonly used 10-item measure (with a 5-point scale) of subjective perceptions of technology usability. To calculate the total SUS score, the responses to all 10 SUS questions are re-scaled and/or re-scored in a way that all items had values from zero to 4 with 4 being the most positive. These converted scores are added and then multiplied by 2.5 to convert the range of possible values 0-100 (instead of from 0 to 40). Higher scores are better.

  Week 4

Secondary Outcomes (4)

• Engagement in Target Activities With Child - Frequency

  Enrollment, and at 4 weeks (after treatment completion)

• Engagement in Target Activities With Child - Self-efficacy

  Enrollment, and at 4 weeks (after treatment completion)

• Family Usage of the SIBTime App - Number of Sessions

  At 4 weeks (after treatment completion)

• Family Usage of the SIBTime App - Program Exposure

  At 4 weeks (after treatment completion)

Study Arms (1)

SIBTime

EXPERIMENTAL

43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).

Behavioral: SIB-Time Web-Application Tool

Interventions

SIB-Time Web-Application Tool BEHAVIORAL

Parents used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, parents used the app at their convenience.

Also known as: SIBTime

SIBTime

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Oregon Research Behavioral Intervention Strategies, Inc.: lead
• Oregon Research Institute: collaborator

Study Sites (1)

Oregon Research Behavioral Intervention Strategies, Inc.

Eugene, Oregon, 97403, United States

Location

Results Point of Contact

• Title: Jessie Marquez
• Organization: Oregon Research Behavioral Intervention Strategies

jessie.marquez@influentsin.com

541-484-2123

Study Officials

• Patricia Vadasy, Ph.D.

  Oregon Research Behavioral Interventions Strategies, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 18, 2020
• Study Start: June 9, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: July 5, 2024
• Results First Posted: July 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)