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| Name | Class |
|---|---|
| Oregon Research Institute | OTHER |
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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.
The investigators conducted a 4-week intervention to assess the English/Spanish, media-enhanced SIBTime web-application tool in terms of its relevance, acceptability, cultural appropriateness, and potential for efficacy to deliver a family-based intervention. The test used a within subjects pre-post design to detect changes in parent self-efficacy, family cohesion, and knowledge, and parent rating of sibling-parent relationship. Additionally, the investigators collected a post-test evaluation of consumer satisfaction and recommendations for modifications to the program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIBTime | Experimental | 43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIB-Time Web-Application Tool | Behavioral | Parents used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, parents used the app at their convenience. |
| Measure | Description | Time Frame |
|---|---|---|
| Parenting & Family Adjustment Scales (PAFAS) Parent/Child Relationship Subscale | 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. | Enrollment, and at 4 weeks (after treatment completion) |
| Parenting & Family Adjustment Scales (PAFAS) Parental Adjustment Subscale | 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. | Enrollment, and at 4 weeks (after treatment completion) |
| Parenting & Family Adjustment Scales (PAFAS) Family Relationships Subscale | 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. | Enrollment, and at 4 weeks (after treatment completion) |
| Self-Efficacy for Parenting Tasks Index (SEPTI) Emotional Availability Subscale | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement in Target Activities With Child - Frequency | 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. |
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Inclusion Criteria
Exclusion Criteria
• N/A
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Vadasy, Ph.D. | Oregon Research Behavioral Interventions Strategies, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Research Behavioral Intervention Strategies, Inc. | Eugene | Oregon | 97403 | United States |
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Participants were parents who were enrolled in the study. Parents completed study measures. Parents engaged in activities with their child, but children were not enrolled and no data were collected from children.
Participants were parents who were enrolled between 6/9/21 and 3/30/22. Participants were recruited through Advisory Board contacts, and social media.
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| ID | Title | Description |
|---|---|---|
| FG000 | SIBTime | 43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion). SIB-Time Web-Application Tool: Parents used the dual-language SIBTime app with their children. They watched video stories about common sibling experiences, responded to question prompts, tracked connection routines, and listened to guided ACT exercises for parents. During the 4-week intervention period, they used the app at their convenience. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | SIBTime | 43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion). SIB-Time Web-Application Tool: Parents used the dual-language SIBTime app with their children to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided ACT exercises for parents. During the 4-week intervention period, parents used the app at their convenience. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Parenting & Family Adjustment Scales (PAFAS) Parent/Child Relationship Subscale | 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. | Primary parents of a child with a disability and a preschool age typically developing child. | Posted | Mean | Standard Deviation | score on a scale | Enrollment, and at 4 weeks (after treatment completion) |
|
1 month (4 weeks)
All-Cause Mortality, Serious Adverse Events and Other Adverse Events were not collected from parents.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SIBTime | 43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion). SIB-Time Web-Application Tool: Parent-child dyads used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided ACT exercises for parents. During the 4-week intervention period, families used the app at their convenience. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessie Marquez | Oregon Research Behavioral Intervention Strategies | 541-484-2123 | jessie.marquez@influentsin.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 10, 2021 | Dec 7, 2023 | Prot_SAP_ICF_000.pdf |
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| Enrollment, and at 4 weeks (after treatment completion) |
| Self-Efficacy for Parenting Tasks Index (SEPTI) Nurturance/Valuing/Empathic Responsiveness Subscale | 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. | Enrollment, and at 4 weeks (after treatment completion) |
| Self-Efficacy for Parenting Tasks Index (SEPTI) Play Subscale | 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. | Enrollment, and at 4 weeks (after treatment completion) |
| Self-Efficacy for Parenting Tasks Index (SEPTI) Teaching Subscale | 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. | Enrollment, and at 4 weeks (after treatment completion) |
| System Usability Scale (SUS) | 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. | Week 4 |
| Enrollment, and at 4 weeks (after treatment completion) |
| Engagement in Target Activities With Child - Self-efficacy | 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. | Enrollment, and at 4 weeks (after treatment completion) |
| Family Usage of the SIBTime App - Number of Sessions | 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. | At 4 weeks (after treatment completion) |
| Family Usage of the SIBTime App - Program Exposure | 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. | At 4 weeks (after treatment completion) |
| Participants |
| No |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Parent Demographic Form | Count of Participants | Participants |
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| Primary | Parenting & Family Adjustment Scales (PAFAS) Parental Adjustment Subscale | 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. | Primary parents of a child with a disability and a preschool age typically developing child. | Posted | Mean | Standard Deviation | score on a scale | Enrollment, and at 4 weeks (after treatment completion) |
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| Primary | Parenting & Family Adjustment Scales (PAFAS) Family Relationships Subscale | 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. | Primary parents of a child with a disability and a preschool age typically developing child. | Posted | Mean | Standard Deviation | score on a scale | Enrollment, and at 4 weeks (after treatment completion) |
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| Primary | Self-Efficacy for Parenting Tasks Index (SEPTI) Emotional Availability Subscale | 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. | Primary parents of a child with a disability and a preschool age typically developing child. | Posted | Mean | Standard Deviation | score on a scale | Enrollment, and at 4 weeks (after treatment completion) |
|
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| Primary | Self-Efficacy for Parenting Tasks Index (SEPTI) Nurturance/Valuing/Empathic Responsiveness Subscale | 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. | Primary parents of a child with a disability and a preschool age typically developing child. | Posted | Mean | Standard Deviation | score on a scale | Enrollment, and at 4 weeks (after treatment completion) |
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| Primary | Self-Efficacy for Parenting Tasks Index (SEPTI) Play Subscale | 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. | Primary parents of a child with a disability and a preschool age typically developing child. | Posted | Mean | Standard Deviation | score on a scale | Enrollment, and at 4 weeks (after treatment completion) |
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| Primary | Self-Efficacy for Parenting Tasks Index (SEPTI) Teaching Subscale | 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. | Primary parents of a child with a disability and a preschool age typically developing child. | Posted | Mean | Standard Deviation | score on a scale | Enrollment, and at 4 weeks (after treatment completion) |
|
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| Primary | System Usability Scale (SUS) | 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. | Primary parents of a child with a disability and a preschool age typically developing child. | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
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| Secondary | Engagement in Target Activities With Child - Frequency | 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. | Primary parents of a child with a disability and a preschool age typically developing child. | Posted | Mean | Standard Deviation | score on a scale | Enrollment, and at 4 weeks (after treatment completion) |
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| Secondary | Engagement in Target Activities With Child - Self-efficacy | 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. | Primary parents of a child with a disability and a preschool age typically developing child. | Posted | Mean | Standard Deviation | score on a scale | Enrollment, and at 4 weeks (after treatment completion) |
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| Secondary | Family Usage of the SIBTime App - Number of Sessions | 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. | Primary parents of a child with a disability and a preschool age typically developing child. | Posted | Mean | Standard Deviation | Number of sessions | At 4 weeks (after treatment completion) |
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| Secondary | Family Usage of the SIBTime App - Program Exposure | 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. | Primary parents of a child with a disability and a preschool age typically developing child. | Posted | Mean | Standard Deviation | Percentage of program exposed to | At 4 weeks (after treatment completion) |
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| 0 |
| 43 |
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| 43 |
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| 43 |
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