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SIBTime Phase II: Web Application for Typically Developing Siblings

O

Oregon Research Behavioral Intervention Strategies

Status

Enrolling

Conditions

Early Life Stress

Treatments

Behavioral: SIB-Time web-application tool

Study type

Interventional

Funder types

Industry
NIH

Identifiers

NCT06099457
2R44MD015947-02 (U.S. NIH Grant/Contract)
MD015947-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

Treatment
Experimental group
Description:
Sibtime web-based intervention.
Treatment:
Behavioral: SIB-Time web-application tool
Control
No Intervention group
Description:
Business as usual.

Trial contacts and locations

1

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Central trial contact

Jessie Marquez, BA; Particia F. Vadasy, PhD

Data sourced from clinicaltrials.gov

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