Clinical trial NCT06099457: SIBTime Phase II: Web Application 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: RECRUITING
Phase: NA
Conditions: Early Life Stress
Keywords: Siblings
Disability
Health concern
Lead sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-10-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Child-Parent Relationship Scale - Short Form
timeFrame: Baseline and Week 9
measure: Parental Stress Scale
timeFrame: Baseline and Week 9
measure: Self-Efficacy for Parenting Tasks Index - Toddler Scale
timeFrame: Baseline and Week 9
measure: Engagement in Target Activities with Child - Frequency Subscale
timeFrame: Baseline and Week 9
measure: Engagement in Program-Targeted Activities with Child - Parents' Self-Efficacy Subscale
timeFrame: Baseline and Week 9
measure: Parents' Rating of their Own Program-Targeted Behaviors
timeFrame: Baseline and Week 9
Secondary outcomes:
measure: Strengths and Difficulties Questionnaire (SDQ) -- Ages 3 to 4
timeFrame: Baseline and Week 9
measure: System Usability Scale (SUS)
timeFrame: Week 9 only
measure: Parent Satisfaction
timeFrame: Week 9 only
measure: Family usage of the SIBTime program
timeFrame: Week 9 only
measure: Commercial Feasibility
timeFrame: Month 21
measure: Sibling Inventory of Behavior
timeFrame: Baseline and Week 9
measure: Parent's Rating of Their Child's Program-Targeted Behaviors
timeFrame: Baseline and Week 9
Other outcomes:
Locations:
city: Springfield
country: United States
facility: David R Smith
state: Oregon
Study officials:
affiliation: Oregon Research Behavioral Intervention Strategies, Inc.
name: Jessie Marquez, BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Berry, J. O., & Jones, W. H. (1995). The Parental Stress Scale: Initial psychometric evidence. Journal of Social and Personal Relationship, 12(3), 463-472.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Sauro J. (2011). A practical guide to the System Usability Scale: Background, benchmarks & best practices. Measuring Usability LLC.