SIBTime Phase II: Web Application for Typically Developing Siblings

Study Overview
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Brief Summary
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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.

Detailed Description
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An 8-week RCT will be conducted to evaluate the full-scale SIBTime program in a sufficiently powered randomized controlled trial evaluation (sample size = 160 parent/child dyads). SIBTime will be assessed in terms of its relevance, acceptability, cultural appropriateness, and efficacy. Participants will complete measures pre- and post- intervention selected to detect changes in parenting stress and adjustment, parent-child relationship, parents' self-efficacy and frequency of engagement in the targeted parenting strategies, and TD sibling behavior and adjustment. Information will also be collected on family demographics, consumer satisfaction, usability ratings, usage metrics, and recommendations for modifications to the program.

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

Conditions
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Early Life Stress

Intervention / Treatment
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* Behavioral: SIB-Time web-application tool


Participation Criteria
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Eligibility Criteria
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Criteria: Inclusion criteria: Parent of a child with a disability and a typically developing child aged 3-6 Has a smartphone or tablet Speaks English or Spanish Exclusion criteria: 1. None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One intervention and two arms (intervention and waitlist control group, treatment-as-usual). Randomly assign 80 parent participants to a treatment condition and 80 to waitlist control group, treatment-as-usual. Conduct an 8-week intervention among the treatment condition participants. At the conclusion of post-intervention testing, deliver the SIBTime intervention to the treatment-as-usual condition participants.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Sibtime web-based intervention. | Behavioral: SIB-Time web-application tool<br>* Parent-child dyads will use the SIBTime app in an 8-week intervention to test its relevance, acceptability, cultural appropriateness, and potential for efficacy.<br>|
| No Intervention: Control<br>Business as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child-Parent Relationship Scale - Short Form | The Child-Parent Relationship Scale - Short Form (CPRS-SF; Driscoll & Pianta, 2011) is comprised of 15 parent-report items that ask the parent to assess the child-parent relationship, the child's emotional stance toward the parent, and the parent's feelings toward the child. Items are answered on a 5-point Definitely does not apply to Definitely applies scale. Higher scores indicate better child-parent relationship. Two subscales are derived: Conflicts and Positive Aspects/Closeness. The CPRS-SF has been validated with parents of preschoolers and first graders, and shows good internal consistency with acceptable Cronbach alphas (.64-.84). | Baseline and Week 9 | 
| Parental Stress Scale | The Parental Stress Scale (PSS; Berry and Jones, 1995) is comprised of 18 items that ask about positive (emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood. Respondents answer on a 5-point Likert Strongly agree to Strongly disagree scale in terms of parent's typical relationship with the child. Higher scores indicate higher parental stress. The PSS shows good internal consistency, test-retest reliability, discriminant validity, and construct validity (Berry & Jones, 1995). It has been validated across cultures and languages (Louie, Cromer, & Berry, 2017), with families of TD children, and with families of children with emotional/ behavioral problems, developmental disabilities (Berry & Jones, 1995), and chronic health conditions (Zelman & Ferro, 2018). | Baseline and Week 9 | 
| Program-Specific Parental Adjustment Scale | This measure was developed for the Phase I project (NCT04633473) and will be used to measure parents' adjustment with respect to parental behaviors targeted in program. Parents are asked to rate the veracity of 5 statements about parenting experiences over the past 4 weeks; responders answer on a 5-point scale, 0 to 4, from Not at all to Very much. Higher scores indicate higher parental stress. Statements address concern with being a good enough parent to the child, worry about meeting the child's needs, and knowing how to make the most of limited time with the child. In the Phase I study (NCT04633473), the scale showed good internal consistency with acceptable Cronbach's alphas (.73-.79), and sensitivity to change. | Baseline and Week 9 | 
| Self-Efficacy for Parenting Tasks Index - Toddler Scale | The Self-Efficacy for Parenting Tasks Index - Toddler Scale (SEPTI-TS; Coleman & Karraker, 2003) will be used to measure parents' self-efficacy for a range of parenting tasks involved in ensuring the wellbeing of the target TD child. Four SEPTI-TS subscales will be used, measuring Emotional Availability (7 items), Nurturance/Valuing/Empathetic Responsiveness (8 items), Play (7 items), and Teaching (9 items), with a 6-point Likert response scale (from 1 to 6; Agree Strongly to Disagree Strongly). Higher scores indicate lower self-efficacy. The SEPTI-TS shows good internal consistency, construct validity, and discriminant validity, and exhibited good sensitivity to change in our Phase 1 study (NCT04633473). | Baseline and Week 9 | 
| Engagement in Target Activities with Child - Frequency | The frequency of parents' engagement in the parenting practices targeted by the intervention will be measured via the Engagement in Target Activities with Child measure. Created for the Phase I (NCT04633473) study, these 22 items ask parents to report the frequency with which they have engaged in target parenting practices in the past month; parents report their frequency on a 7-point scale (from 0 to 6; Never in the past month to 6 or more times per day). Four subscales are derived: one-on-one involvement (4 items), considerations of parenting the TD child (5 items), listen/talk/facilitate learning about disability (5 items), and positive attention and affection (2 items). Higher scores indicate more frequent parental engagement in the target activities. In the Phase I study (NCT04633473), these subscales showed acceptable internal consistency and good sensitivity to change. | Baseline and Week 9 | 
| Engagement in Target Activities with Child - Parental Self-Efficacy | Parents' self-efficacy for engaging in the parenting practices targeted by the intervention will be measured via the Engagement in Target Activities with Child measure. Created for the Phase I study (NCT04633473), these 22 items ask parents to rate how confident they are in doing the program-targeted parenting practices, on a scale of 1 to 10 (Not at all confident to Highly confident). Four subscales are derived: one-on-one involvement (4 items), considerations of parenting the TD child (5 items), listen/talk/facilitate learning about disability (5 items), and positive attention and affection (2 items). Higher scores indicate greater parental self-efficacy in doing target activities. In the Phase I study (NCT04633473), these subscales showed acceptable internal consistency and good sensitivity to change. | Baseline and Week 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sibling Perception Questionnaire - Parent version | The 18-item Parent version of the Sibling Perception Questionnaire (SPQ-P) will be used to measure parents' reports of the TD child's adjustment to the sibling's disability. The parent version of the SPQ was adapted by Lobato and Kao (2002) from the original child-report version of the SPQ for 8-13 year-old siblings of children with cancer (Sahler & Carpenter, 1989). The SPQ-P will be adapted for younger children ages 3-6. The 18 items on the SPQ-P ask parents to rate, on a 4-point scale (Never to A lot), the TD child's interpersonal difficulties, intrapersonal difficulties, and fear of the sibling's condition. Higher score indicates more negative sibling perceptions. All items are combined into a single composite Negative Adjustment scale, which shows good internal consistency (alpha = .74). The SPQ-P has been validated with parents of children with disabilities and against sibling self-reports (Guite, Lobato, Kao, & Plante, 2010). | Baseline and Week 9 | 
| Strengths and Difficulties Questionnaire (SDQ) -- Ages 3 to 4 | Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) will be used to measure the TD child's overall adjustment. The SDQ is a brief, valid, reliable, and commonly used 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. Respondents answer on a 3-point Not true to Certainly true scale. Higher score indicates worse adjustment. The SDQ shows good construct and discriminant validity, and is sensitive to both child internalizing and externalizing behavior. | Baseline and Week 9 | 
| System Usability Scale (SUS) | The SIBTime app's usability will be measured with the System Usability Scale (SUS; Brooke, 1996), a commonly used 10-item scale that measures subjective perceptions of usability on a 5-point Likert scale, from 1 to 5, indicating Strongly Disagree to Strongly Agree. Higher score indicates greater satisfaction. The SUS has been normed, and scoring produces an overall usability grade (Brooke, 1996; Sauro, 2011). This measure will be obtained from treatment participants only at posttest. | Week 9 only | 
| Parent satisfaction with the SIBTime program | Parents' satisfaction with the SIBTime program will be measured with 19 items that ask parents to rate, on a 5-point Likert response scale, the degree to which the SIBTime app was helpful, useful, relevant to family needs, enjoyable, met expectations, the degree to which parents would recommend the program to other parents. This measure will be obtained from treatment participants only at posttest. | Week 9 only | 
| Family usage of the SIBTime program | Family usage of the SIBTime app will be measured through metrics collected on the back-end database, including activation of the program; which program elements are accessed; frequency, timing, and duration of engagements; and points of difficulty or failure. These metrics will be collected from users in the treatment condition only. | Week 9 only | 
| Demographics | Family demographics (household composition, gender, ethnicity/race, education level, employment, income, economic hardship) will be collected from parents at pretest only. | Baseline | 
| Commercial Feasibility | Commercial feasibility will be measured with the Practitioner Satisfaction & Program Acceptability measure, 20 items that Advisory Board members and recruitment partners will complete. These items measure SIBTime's acceptability for the target families these practitioners serve, feasibility for use among agencies, and interest in purchasing and adopting SIBTime. | Month 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Siblings, Disability, Health concern