Autism Spectrum DisorderNCT03372421
The Use of Social Stories to Reduce Negative Affect and Improve Satisfaction in Adults Attending an ASD Assessment
A study testing Social Story and Standard Information in people with Autism Spectrum Disorder, run by University of Sheffield at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Social Story and Standard Information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 May 2018to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People who are awaiting an ASD assessment at the host site.
- People who have never visited the site before.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Adult Autism and Neurodevelopmental Service
Sheffield, South Yorkshire, S11 9BF
About this study
Official title: The Use of Social Stories to Reduce Negative Affect and Improve Satisfaction in Adults Attending an Assessment for Autism Spectrum Disorder
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Social Story, Standard Information
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social StoryOther
A short story written in the third person about what it's like to attend an assessment for ASD.
Standard InformationOther
Information the host site currently sends out to patients informing them about what to expect from the assessment
| Study group | Role | What they receive |
|---|---|---|
| Social Story | Experimental | Participants will read information about what to expect from the assessment in the format of a Social Story Receives: Other: Social Story |
| Standard Information | Active comparator | Participants will read standard information about what to expect from the assessment. Receives: Other: Standard Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change scores: baseline and 3 weeks
Secondary outcomes (2)
Assessment Satisfaction
Participants will be asked to rate their overall satisfaction with the diagnostic assessment, on a 5 point Likert scale.
Measured: 3 weeks
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start26 May 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Jenkinson, University of Sheffield
- Investigators
- Richard p Jenkinson, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372421
- Sponsor's protocol ID
- rjenkinson001
- Status last verified
- Aug 2019
- First submitted
- 4 Dec 2017
- Last updated
- 30 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared in order to protect the participants' confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Social Stories to Reduce Negative Affect and Improve Satisfaction in Adults Attending an Assessment for Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03372421
- Acronym / sponsor ID
- rjenkinson001
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- 26 May 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Story | Experimental | Other: Social StoryParticipants will read information about what to expect from the assessment in the format of a Social Story |
| Standard Information | Active comparator | Other: Standard InformationParticipants will read standard information about what to expect from the assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- People who are awaiting an ASD assessment at the host site.
- People who have never visited the site before.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social StoryA short story written in the third person about what it's like to attend an assessment for ASD. | Other | Social Story |
| Standard InformationInformation the host site currently sends out to patients informing them about what to expect from the assessment | Other | Standard Information |
Primary outcome
Positive and Negative Affect Schedule
Time frame: Change scores: baseline and 3 weeks
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).
2 secondary outcomes
Assessment Satisfaction
Time frame: 3 weeks
Predictability
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- The website of the author of Social Stories with guidance on writing Social Stories.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual data will not be shared in order to protect the participants' confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard p Jenkinson principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Story and Standard Information in people with Autism Spectrum Disorder, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Affect Schedule (time frame: Change scores: baseline and 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.