The Use of Social Stories to Reduce Negative Affect and Improve Satisfaction in Adults Attending an ASD Assessment
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Social Story
Standard Information
Sponsored by
About this trial
This is an interventional supportive care trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- People who are awaiting an ASD assessment at the host site.
- People who have never visited the site before.
Exclusion Criteria:
- People who do not receive a diagnosis of ASD following the study will not be included in the inferential statistical analysis. However, they will still be participants in the study and their data will be reported descriptively.
Sites / Locations
- Sheffield Adult Autism and Neurodevelopmental Service
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Social Story
Standard Information
Arm Description
Participants will read information about what to expect from the assessment in the format of a Social Story
Participants will read standard information about what to expect from the assessment.
Outcomes
Primary Outcome Measures
Positive and Negative Affect Schedule
A widely used self-report measure of positive and negative affect with good psychometric properties (Crawford & Henry, 2004) and has been used in previous research to measure negative affect in people with ASD (Samson, Huber, & Gross, 2012).
Secondary Outcome Measures
Assessment Satisfaction
Participants will be asked to rate their overall satisfaction with the diagnostic assessment, on a 5 point Likert scale.
Predictability
Participants will be asked to rate, on a 5 point Likert scale, to what extent the information they read prior to their assessment has thus far helped them to know what to expect from the assessment.
Full Information
NCT ID
NCT03372421
First Posted
December 4, 2017
Last Updated
August 29, 2019
Sponsor
University of Sheffield
1. Study Identification
Unique Protocol Identification Number
NCT03372421
Brief Title
The Use of Social Stories to Reduce Negative Affect and Improve Satisfaction in Adults Attending an ASD Assessment
Official Title
The Use of Social Stories to Reduce Negative Affect and Improve Satisfaction in Adults Attending an Assessment for Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 26, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sheffield
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Many people with Autism Spectrum Disorder (ASD) find the unpredictability of social situations emotionally distressing. It is likely that attending a diagnostic assessment is no exception. Social Stories are short stories that describe a social situation so that people know what to expect. They are written in a way that is accessible to people with ASD. This study will explore whether a Social Story written about a diagnostic assessment can reduce the associated emotional distress and increase people's satisfaction with the process. If so, they could be a simple way that services can better cater for their clients' needs.
Detailed Description
An invitation to participate in the study will be included with every appointment letter sent out by the host site(s) whilst recruitment is active. The invitation will invite participants to visit a website (hosted by Qualtrics) where they will be provided with information about the study and asked if they would like to provide informed consent to participate. If consent is given, they will be asked to complete an online version of the Positive and Negative Affect Schedule (PANAS; time 1). Contact information will also be requested at this point.
Participants will then be randomly allocated to either an experimental group or to a control group. Participants in the experimental group will read a Social Story about what to expect from their assessment; participants in the control group will read the standard information the host service sends out about what to expect from their assessment. Participants will be blinded to which group they are in.
If the participants choose to supply a mobile telephone number and email address, an SMS text message and/or email reminder will be sent out one week prior to their assessment and again on the morning of the assessment. These reminders will include hyperlinks to the information about what to expect and will remind them to complete the PANAS once they arrive at their appointment.
On arrival at their assessment (time 2), participants will complete a paper copy of the PANAS questionnaire and will be asked for demographic information. Participants will also be asked to rate the extent that the information they read prior to attending the assessment has helped them to know what to expect thus far. Paper copies of the questionnaire will be left in the waiting area with instructions to hand them into staff once complete.
One week following their assessment (time 3), participants will receive another SMS/email which will include a hyperlink to a post-assessment survey that will ask participants to rate their satisfaction with the assessment and whether they received a diagnosis of ASD. Participants who do not complete this questionnaire after one week will be contacted one final time. All participants will be sent a debriefing sheet.
Hypotheses
Compared with participants who read standard, non-social information prior to attending an assessment for ASD, participants who read a Social Story will report, on average, less of an increase in negative affect when attending their assessment, as measured by the negative subscale of the PANAS.
Participants who read a Social Story prior to attending an assessment for ASD will report, on average, higher satisfaction (measured via a 5 point Likert scale) with the assessment than participants who read standard, non-social information.
Compared with participants who read standard, non-social information prior to attending an assessment for ASD, participants who read a Social Story will report, on average, that the assessment was more predictable (measured via a 5 point Likert scale).
Data Analysis
Comparison of means using a 2 (group; SS, control) X 2 (time; time 1, time 2) mixed ANOVA (repeated measures on the time factor). Dependent variable = PANAS score.
Comparison of means using an independent t-test at time 2. Independent variable = group (2 levels; SS and control). Dependent variable = PANAS score.
Descriptive statistics.
Comparison of means using the Mann-Whitney U test at time 3. Independent variable = group (2 levels; SS and control). Dependent variable = satisfaction score.
Descriptive statistics.
Descriptive statistics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will not be told whether they are in the experimental or control group.
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Social Story
Arm Type
Experimental
Arm Description
Participants will read information about what to expect from the assessment in the format of a Social Story
Arm Title
Standard Information
Arm Type
Active Comparator
Arm Description
Participants will read standard information about what to expect from the assessment.
Intervention Type
Other
Intervention Name(s)
Social Story
Intervention Description
A short story written in the third person about what it's like to attend an assessment for ASD.
Intervention Type
Other
Intervention Name(s)
Standard Information
Intervention Description
Information the host site currently sends out to patients informing them about what to expect from the assessment
Primary Outcome Measure Information:
Title
Positive and Negative Affect Schedule
Description
A widely used self-report measure of positive and negative affect with good psychometric properties (Crawford & Henry, 2004) and has been used in previous research to measure negative affect in people with ASD (Samson, Huber, & Gross, 2012).
Time Frame
Change scores: baseline and 3 weeks
Secondary Outcome Measure Information:
Title
Assessment Satisfaction
Description
Participants will be asked to rate their overall satisfaction with the diagnostic assessment, on a 5 point Likert scale.
Time Frame
3 weeks
Title
Predictability
Description
Participants will be asked to rate, on a 5 point Likert scale, to what extent the information they read prior to their assessment has thus far helped them to know what to expect from the assessment.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
People who are awaiting an ASD assessment at the host site.
People who have never visited the site before.
Exclusion Criteria:
People who do not receive a diagnosis of ASD following the study will not be included in the inferential statistical analysis. However, they will still be participants in the study and their data will be reported descriptively.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard p Jenkinson
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Adult Autism and Neurodevelopmental Service
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S11 9BF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual data will not be shared in order to protect the participants' confidentiality
Links:
URL
https://carolgraysocialstories.com/
Description
The website of the author of Social Stories with guidance on writing Social Stories.
Learn more about this trial
The Use of Social Stories to Reduce Negative Affect and Improve Satisfaction in Adults Attending an ASD Assessment
We'll reach out to this number within 24 hrs