18 and older, any sex, with Family Relations or Sibling Relations. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Parenting & Family Adjustment Scales (PAFAS) Parent/Child Relationship SubscalePrimary· Enrollment, and at 4 weeks (after treatment completion)
The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) Parent/Child Relationship subscale measures the quality of the parent-child relationship, asking how true various statements have been over the past 4 weeks. The Parent/Child Relationship subscale is measured with 5 items, answered on a 5-point scale (0=Not at all; 4=Very much). Average scores range from 0 to 4, with higher scores indicating worse outcomes.
Pretest
Group
Value
95% CI
SIBTime
0.26
± 0.32
Posttest
Group
Value
95% CI
SIBTime
0.26
± 0.35
Parenting & Family Adjustment Scales (PAFAS) Parental Adjustment SubscalePrimary· Enrollment, and at 4 weeks (after treatment completion)
The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) measures change in parenting practices, family cohesion, parent-child relationship quality, and parents' stress. The 30 items on the PAFAS sort into 7 subscales: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner. Items are rated on a 5-point scale (0-4) with higher scores worse.
Pretest
Group
Value
95% CI
SIBTime
1.17
± 0.71
Posttest
Group
Value
95% CI
SIBTime
1.07
± 0.64
Parenting & Family Adjustment Scales (PAFAS) Family Relationships SubscalePrimary· Enrollment, and at 4 weeks (after treatment completion)
The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) measures change in parenting practices, family cohesion, parent-child relationship quality, and parents' stress. The 30 items on the PAFAS sort into 7 subscales: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner. Items are rated on a 5-point scale (0-4) with higher scores worse.
Pretest
Group
Value
95% CI
SIBTime
0.99
± 0.59
Posttest
Group
Value
95% CI
SIBTime
0.94
± 0.58
Self-Efficacy for Parenting Tasks Index (SEPTI) Emotional Availability SubscalePrimary· Enrollment, and at 4 weeks (after treatment completion)
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Emotional Availability subscale measures parents' self-efficacy for providing emotional support to their typically developing child and meeting their child's emotional needs. Parents rate their agreement or disagreement with a series of statements. The SEPTI Emotional Availability subscale is measured with 7 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Pretest
Group
Value
95% CI
SIBTime
2.07
± 0.69
Posttest
Group
Value
95% CI
SIBTime
1.93
± 0.51
Self-Efficacy for Parenting Tasks Index (SEPTI) Nurturance/Valuing/Empathic Responsiveness SubscalePrimary· Enrollment, and at 4 weeks (after treatment completion)
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Nurturance/Valuing/Empathic Responsiveness subscale measures parents' self-efficacy for providing empathy, nurturance, and understanding to their typically developing child. Parents rate their agreement or disagreement with a series of statements. The SEPTI Nurturance/Valuing/Empathic Responsiveness subscale is measured with 8 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Pretest
Group
Value
95% CI
SIBTime
1.93
± 0.50
Posttest
Group
Value
95% CI
SIBTime
1.75
± 0.37
Self-Efficacy for Parenting Tasks Index (SEPTI) Play SubscalePrimary· Enrollment, and at 4 weeks (after treatment completion)
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Play subscale measures parents' self-efficacy for playing with and having fun with their typically developing child. Parents rate their agreement or disagreement with a series of statements. The SEPTI Play subscale is measured with 7 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Pretest
Group
Value
95% CI
SIBTime
2.98
± 1.17
Posttest
Group
Value
95% CI
SIBTime
2.64
± 0.89
Self-Efficacy for Parenting Tasks Index (SEPTI) Teaching SubscalePrimary· Enrollment, and at 4 weeks (after treatment completion)
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Teaching subscale measures parents' self-efficacy for explaining things and teaching their typically developing child about the world in a way that their child can understand. Parents rate their agreement or disagreement with a series of statements. The SEPTI Teaching subscale is measured with 9 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Pretest
Group
Value
95% CI
SIBTime
2.39
± 0.74
Posttest
Group
Value
95% CI
SIBTime
2.23
± 0.68
System Usability Scale (SUS)Primary· Week 4
The System Usability Scale (SUS) is a commonly used 10-item measure (with a 5-point scale) of subjective perceptions of technology usability. To calculate the total SUS score, the responses to all 10 SUS questions are re-scaled and/or re-scored in a way that all items had values from zero to 4 with 4 being the most positive. These converted scores are added and then multiplied by 2.5 to convert the range of possible values 0-100 (instead of from 0 to 40). Higher scores are better.
Group
Value
95% CI
SIBTime
81.99
± 14.47
Engagement in Target Activities With Child - FrequencySecondary· Enrollment, and at 4 weeks (after treatment completion)
The Engagement in Target Activities with Child - Frequency subscale measures the frequency with which parents report engaging in specific "connection routine" activities with their typically developing child in the past month, across 17 items reflecting a range of program-targeted parenting behaviors. Respondents answer on a 7-point frequency scale (0=Never in the past month; 6=6 or more times per day); average scores range from 0 to 6, with higher scores indicating better outcomes.
Pretest
Group
Value
95% CI
SIBTime
3.62
± 0.80
Posttest
Group
Value
95% CI
SIBTime
3.88
± 0.87
Engagement in Target Activities With Child - Self-efficacySecondary· Enrollment, and at 4 weeks (after treatment completion)
The Engagement in Target Activities with Child - Self-Efficacy subscale measures parents' self-efficacy for engaging in specific "connection routine" activities with their typically developing child in the past month, across 17 items reflecting a range of program-targeted parenting behaviors. Respondents answer on a 10-point scale of how confident they are that they can carry out these behaviors (1=Not at all confident; 10=Highly confident); average scores range from 1 to 10, with higher scores indicating better outcomes.
Pretest
Group
Value
95% CI
SIBTime
7.65
± 1.46
Posttest
Group
Value
95% CI
SIBTime
8.56
± 1.10
Family Usage of the SIBTime App - Number of SessionsSecondary· At 4 weeks (after treatment completion)
Measure the families' usage of the SIBTime app using metrics and transcripts collected on the back-end database, including activation of the app; which elements are accessed; frequency, timing, and duration of engagements; and points of difficulty or failure.
Group
Value
95% CI
SIBTime
5.6
± 4.2
Family Usage of the SIBTime App - Program ExposureSecondary· At 4 weeks (after treatment completion)
Measure the families' usage of the SIBTime app using metrics and transcripts collected on the back-end database, including activation of the app; which elements are accessed; frequency, timing, and duration of engagements; and points of difficulty or failure.
Group
Value
95% CI
SIBTime
69.9
± 34.3
Sponsor's own description
In the United States, over 32.7 million people have special health, developmental, and mental health concerns. Most of these people have typically developing brothers and sisters. Across the lifespan, siblings share high levels of involvement in each other's lives, and also many of the concerns that parents of children with special needs experience, including isolation, a need for information, concerns about the future, and caregiving demands. Brothers and sisters also face issues that are uniquely theirs including emotions (resentment, worry, embarrassment, guilt), peer issues, and family communication challenges. The team of researchers, developers, and consultants built and tested an assistive media enhanced web-application tool for developing knowledge, skills, and routines for attending to TD siblings' (ages 3-5) social-emotional health and well-being.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oregon Research Behavioral Intervention Strategies, Inc.
Last refreshed: 5 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04633473.