SIBTime Phase II: Web Application for Typically Developing Siblings

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

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.

Study Overview

• Status: Recruiting
• Conditions: Early Life Stress
• Intervention / Treatment: Behavioral: SIB-Time web-application tool

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessie Marquez, BA; Phone Number: 541-484-2123; Email: jessie.marquez@influentsin.com
• Study Contact Backup: Name: Particia F. Vadasy, PhD; Phone Number: 541-484-2123; Email: patricia.vadasy@influentsin.com

Study Locations

• United States
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Recruiting
      • David R Smith
      • Contact: David R Smith, PhD; Phone Number: 541-484-2123; Email: David.Smith@influentsin.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Criteria:

Inclusion criteria:

1. Parent of a child with a disability and a typically developing child aged 3-6
2. Has a smartphone or tablet
3. Speaks English or Spanish

Exclusion criteria:

1. None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Jessie Marquez, BA, Oregon Research Behavioral Intervention Strategies, Inc.

Publications and helpful links

General Publications

• Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
• Lobato DJ, Kao BT. Integrated sibling-parent group intervention to improve sibling knowledge and adjustment to chronic illness and disability. J Pediatr Psychol. 2002 Dec;27(8):711-6. doi: 10.1093/jpepsy/27.8.711.
• Driscoll, K., & Pianta, R. C. (2011). Mothers' and fathers' perceptions of conflict and closeness in parent-child relationships during early childhood. Journal of Early Childhood and Infant Psychology, 7, 1-24.
• Berry, J. O., & Jones, W. H. (1995). The Parental Stress Scale: Initial psychometric evidence. Journal of Social and Personal Relationship, 12(3), 463-472.
• Louie, A. D., Cromer, L. D., & Berry, J. O. (2017). Assessing parenting stress: Review of the use and interpretation of the Parental Stress Scale. The Family Journal, 25(4), 359-367.
• Zelman, J. J. & Ferro, M. A. (2018). The Parental Stress Scale: Psychometric properties in families of children with chronic health conditions. Family Relations, 67(2), 240-252.
• Coleman, P. K. & Karraker, K. H. (2003). Maternal self-efficacy beliefs, competence in parenting, and toddlers' behavior and developmental status. Infant Mental Health Journal, 24(2), 126-148.
• Sahler OJ, Carpenter PJ. Evaluation of a camp program for siblings of children with cancer. Am J Dis Child. 1989 Jun;143(6):690-6. doi: 10.1001/archpedi.1989.02150180068023.
• Guite, J., Lobato, D., Kao, B, & Plante, W. (2010). Discordance between sibling and parent reports of the impact of chronic illness and disability on siblings. Children's Health Care, 33(1), 77-92.
• Brooke, J. (1996). SUS: A "quick and dirty" usability scale. In P. W. Jordan, B. Thomas, B. A. Weerdmeester, & A. L. McClelland (Eds.), Usability evaluation in industry. Taylor and Francis.
• Sauro J. (2011). A practical guide to the System Usability Scale: Background, benchmarks & best practices. Measuring Usability LLC.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2023
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Disability; Siblings; Health concern
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: MD015947-02; 2R44MD015947-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No