NCT03372421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 26, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

December 4, 2017

Last Update Submit

August 29, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    Change scores: baseline and 3 weeks

Secondary Outcomes (2)

  • Assessment Satisfaction

    3 weeks

  • Predictability

    3 weeks

Study Arms (2)

Social Story

EXPERIMENTAL

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

Other: Social Story

Standard Information

ACTIVE COMPARATOR

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

Other: Standard Information

Interventions

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

Social Story

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

Standard Information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People who are awaiting an ASD assessment at the host site.
  • People who have never visited the site before.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Adult Autism and Neurodevelopmental Service

Sheffield, South Yorkshire, S11 9BF, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Richard p Jenkinson

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be told whether they are in the experimental or control group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trainee Clinical Psychologist

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 13, 2017

Study Start

May 26, 2018

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

August 30, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Individual data will not be shared in order to protect the participants' confidentiality

Locations