The Use of Social Stories to Reduce Negative Affect and Improve Satisfaction in Adults Attending an ASD Assessment

NCT ID: NCT03372421

Last Updated: 2019-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-26

Study Completion Date

2019-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

1. 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.
2. 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.
3. 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

1. 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.
2. 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.
3. Descriptive statistics.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Participants will not be told whether they are in the experimental or control group.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Social Story

Participants will read information about what to expect from the assessment in the format of a Social Story

Group Type EXPERIMENTAL

Social Story

Intervention Type OTHER

A short story written in the third person about what it's like to attend an assessment for ASD.

Standard Information

Participants will read standard information about what to expect from the assessment.

Group Type ACTIVE_COMPARATOR

Standard Information

Intervention Type OTHER

Information the host site currently sends out to patients informing them about what to expect from the assessment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Social Story

A short story written in the third person about what it's like to attend an assessment for ASD.

Intervention Type OTHER

Standard Information

Information the host site currently sends out to patients informing them about what to expect from the assessment

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sheffield

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Richard Jenkinson

Trainee Clinical Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Richard p Jenkinson

Role: PRINCIPAL_INVESTIGATOR

University of Sheffield

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sheffield Adult Autism and Neurodevelopmental Service

Sheffield, South Yorkshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

https://carolgraysocialstories.com/

The website of the author of Social Stories with guidance on writing Social Stories.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

rjenkinson001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

More and Less Social Comprehension
NCT06116552 RECRUITING NA