SIB-Time Web-application Tool

Study Overview
=================
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 lifespan, siblings share high levels of involvement in each other's lives, and 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 propose to build and test assistive a 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 will conduct a 4-week intervention to assess the feasibility of SIBTime web-application tool in terms of its relevance, acceptability, cultural appropriateness, and potential for efficacy. The test will use 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, we will collect a post-test evaluation of consumer satisfaction and recommendations for modifications to the program.

Official Title
-----------------
SIBTime: Media-enhanced Technology for Promoting the Behavioral Health and Family Relationships of Typically Developing Young Siblings

Conditions
-----------------
Family Relations, Sibling Relations

Intervention / Treatment
-----------------
* Behavioral: SIB-Time Web-Application Tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Be a client of a partner agency and have a child with a disability Have a typically developing child 3-5 years old who lives with them at least half the time Be the primary parent in the home (typically this will be the mother, but not always) Speak English Have access to a computer, tablet, or smartphone Exclusion 1. N/A

Ages Eligible for Study
-----------------
Minimum Age: 3 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIBTime<br>50 primary parents will be assessed at enrollment, then provided the SIBTime technology and exposed to the learning routines for 4 weeks, and then re-assessed at 4 weeks (after treatment completion). | Behavioral: SIB-Time Web-Application Tool<br>* Parent-child dyads will use the SIBTime app in a 4-week intervention to test its relevance, acceptability, cultural appropriateness, and potential for efficacy.<br>* Other names: SIBTime;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenting & Family Adjustment Scales (PAFAS) | Measure change using The Parenting & Family Adjustment Scales (PAFAS; Sanders et al., 2014) it will be used to measure change in parenting practices, family cohesion, parent-child relationship quality, and parents' stress. The 30 items on the PAFAS sort into 7 subscales with good internal consistency and construct validity: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner. The PAFAS will be adapted to include additional items about the presence of a connection routine and parents' satisfaction with how that routine is going. | Enrollment, at 4 weeks (after treatment completion) | 
| Self-Efficacy for Parenting Tasks Index (SEPTI) | Measure change using The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman & Karraker, 2000) it will be used to measure change in parents' self-efficacy for a broad range of parenting tasks involved in ensuring the well-being of the target TD sibling. The SEPTI has 36 items across 5 domains (recreation/peer relations, nurturance, discipline, health, and achievement), with a 6-point Likert response scale (Strongly agree to Strongly disagree). The SEPTI shows good internal consistency, and construct and discriminant validity. The SEPTI will be adapted to include additional items addressing parents' self-efficacy for doing specific parenting tasks targeted in the SIBTime intervention (connection routine activities with TD sibling). | Enrollment, at 4 weeks (after treatment completion) | 
| Child Adjustment & Parent Self-Efficacy Scale (CAPES) | Measure change using The Child Adjustment & Parent Efficacy Scale (CAPES; Morawska et al., 2014) it measures change in children's behaviors and emotional adjustment. The Behavior Problems subscale consists of 16 problematic and 8 reverse-coded positive behaviors; the Emotional Maladjustment subscale has 3 items. The CAPES is highly correlated with the Eyberg Child Behavior Inventory (ECBI, a common measure for children's behavior problems), but the CAPES has the added advantage that it includes positive behavior and emotional maladjustment items, and is less burdensome for parents to complete. The CAPES will also be used to measure parents' self-efficacy; parents rate their confidence that they can successfully deal with each of the 19 negative behaviors/emotions on the CAPES. | Enrollment, at 4 weeks (after treatment completion) | 
| System Usability scale (SUS) | Measure change using the System Usability Scale (SUS), a commonly used 10-item scale that measures change in subjective perceptions of usability in the SIBTime app's usability System Usability Scale (SUS), a commonly used 10-item scale that measures change in subjective perceptions of usability. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strengths and Difficulties Questionnaire (SDQ). | Measure change in the Strengths and Difficulties Questionnairre (Goodman, 1997) The Strengths and Difficulties Questionnaire is a brief, valid, and reliable parent-report questionnaire about child behavior that can be completed in about 5 minutes. The instrument includes 25 items that assess child challenging behaviors (emotional symptoms, conduct problems, hyperactivity/inattention), peer relationships, and prosocial behavior. The SDQ shows good construct and discriminant validity, and is sensitive to both child internalizing and externalizing behavior. | Enrollment, at 4 weeks (after treatment completion) | 
| Engagement in Target Activities with Child | Measure change in the frequency of families' engagement in activities targeted by the intervention will be measured at both enrollment and 4 weeks (after treatment completion) via the Engagement in Target Activities with Child measure on the parent questionnaire. Items will ask parents to report the frequency with which specific connection routine activities have occurred in the past month, and parents will report their frequency on a 7-point scale (Never in the past month to 6 or more times per day). | Enrollment | 
| Family usage of the SIBTime app | Measure change in the families' usage of the SIBTime app. Measure change using metrics and transcripts collected on the back-end database, including activation of the app; which elements are accessed; frequency, timing, and duration of engagements; and points of difficulty or failure. | At 4 weeks (after treatment completion) | 
| Demographics | Family demographics (household composition, ethnicity/race, education level, income, economic hardship, employment, etc.) will be measured on the parent questionnaire at pretest only. | Enrollment | 
| Commercial Feasibility | The Satisfaction & Program Acceptability measure, 20 items that Advisory Board members and recruitment partners will complete. These items measure SIBTimes's acceptability for the target families these practitioners serve, feasibility for use among agencies, and their interest in purchasing and adopting SIBTime. | Month 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Social Emotional Health