SIBTime Phase II: Web Application for Typically Developing Siblings

NCT06099457 | Active Not Recruiting

• 2 other identifiers: MD015947-022R44MD015947-02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Life Stress

Keywords

Siblings; Disability; Health concern

Outcome Measures

Primary Outcomes (6)

• Child-Parent Relationship Scale - Short Form

  The Child-Parent Relationship Scale - Short Form (CPRS-SF; Driscoll \& Pianta, 2011) is used to measure the degree of closeness and conflict in the parent-child relationship. The CPRS-SF is comprised of 15 parent-report items that ask the parent for their assessment of 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. Two subscales are derived: Conflicts and Positive Aspects/Closeness. Both subscales are measured by 7 items, which are averaged together; average scores range from 1 to 5. For the Conflicts subscale, higher scores indicate worse outcomes; for the Closeness subscale, higher scores indicate better outcomes. 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 used to measure parents' stress level. The PSS 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 their typical relationship with their child(ren). Summed scores range from 18 to 90, with higher scores indicating worse outcomes. 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

• Self-Efficacy for Parenting Tasks Index - Toddler Scale

  The Self-Efficacy for Parenting Tasks Index - Toddler Scale (SEPTI-TS; Coleman \& Karraker, 2003) is used to measure parents' self-efficacy for a broad range of parenting tasks involved in ensuring the wellbeing of the target TD child. Four subscales of the SEPTI will be used: Emotional Availability (7 items), Nurturance/Valuing/ Empathetic Responsiveness (8 items), Play (7 items), and Teaching (9 items). Items are answered on a 6-point Likert response scale (1= Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating lower self-efficacy (worse outcome). The SEPTI-TS shows good internal consistency, construct validity, discriminant validity, and sensitivity to change.

  Baseline and Week 9

• Engagement in Target Activities with Child - Frequency Subscale

  The frequency of parents' engagement in the parenting practices targeted by the intervention is measured via the Engagement in Target Activities with Child measure, Frequency subscale. Created for this 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 ("Never in the past month" to "6 or more times per day"). Averaged scores range from 0 to 6, with higher scores indicating more frequent parental engagement in the target activities (better outcome).

  Baseline and Week 9

• Engagement in Program-Targeted Activities with Child - Parents' Self-Efficacy Subscale

  Parents' self-efficacy for engaging in the parenting practices targeted by the intervention is measured via the Engagement in Target Activities with Child measure, Parents' Self-Efficacy subscale. Created for this study, these 22 items ask parents to rate how confident they are that they know how to do a series of parenting practices targeted by the program, on a scale of 0 to 4 (0 = I don't know how to do this at all, 4 = I know how to do this very well). Averaged scores range from 0 to 4, with higher scores indicating greater parental self-efficacy that they know how to do the target activities (better outcome).

  Baseline and Week 9

• Parents' Rating of their Own Program-Targeted Behaviors

  Parents' perception of their TD child's engagement in program-targeted behaviors is measured with parents' rating on 4 child behaviors targeted by the program, and one item asking about the child's general adjustment to their sibling's disability/illness. Created for this study, 4 of the items ask parents to report the frequency with which their TD child has engaged in target behaviors in the past month; parents report their frequency on a 7-point scale ("Never in the past month" to "6 or more times per day"). Averaged scores range from 0 to 6, with higher scores indicating more frequent child engagement in the target activities (better outcome). The 5th item asks parents how satisfied they are with how well their TD child is doing, as a sibling of a child with a disability or health concern. Parents respond on a scale of 1 to 10, with 1 = Not at all satisfied and 10 = Very satisfied.

  Baseline and Week 9

Secondary Outcomes (7)

• Strengths and Difficulties Questionnaire (SDQ) -- Ages 3 to 4

  Baseline and Week 9

• System Usability Scale (SUS)

  Week 9 only

• Parent Satisfaction

  Week 9 only

• Family usage of the SIBTime program

  Week 9 only

• Commercial Feasibility

  Month 21

Study Arms (2)

Treatment

EXPERIMENTAL

Sibtime web-based intervention.

Behavioral: SIB-Time web-application tool

Control

NO INTERVENTION

Business as usual.

Interventions

SIB-Time web-application tool BEHAVIORAL

Parent-child dyads will use the SIBTime app in an 8-week intervention to test its relevance, acceptability, cultural appropriateness, and potential for efficacy.

Treatment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• \. None

Sponsors & Collaborators

• Oregon Research Behavioral Intervention Strategies, Inc.: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

David R Smith

Springfield, Oregon, 97477, United States

Location

Related Publications (11)

• 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.

  BACKGROUND

• Berry, J. O., & Jones, W. H. (1995). The Parental Stress Scale: Initial psychometric evidence. Journal of Social and Personal Relationship, 12(3), 463-472.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 12403861 BACKGROUND

• 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.

  PMID: 2729214 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 9255702 BACKGROUND

• 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.

  BACKGROUND

• Sauro J. (2011). A practical guide to the System Usability Scale: Background, benchmarks & best practices. Measuring Usability LLC.

  BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jessie Marquez, BA

  Oregon Research Behavioral Intervention Strategies, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: October 27, 2023
• Primary Completion: February 2, 2026
• Study Completion: April 8, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)