NCT02797379

Brief Summary

The purpose of this pilot intervention trial is to assess the efficacy of newly developed psychoeducation guides designed to manage anxiety in Autism Spectrum Disorder (ASD) by recruiting 30 participants with ASD and high levels of anxiety along with their parent/caregivers who both receive a version of the psychoeducation guide.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2016

Enrollment Period

12 months

First QC Date

May 24, 2016

Last Update Submit

September 12, 2019

Conditions

Autism Spectrum DisordersAnxiety

Keywords

PsychoeducationSelf-help

Outcome Measures

Primary Outcomes (1)

  • Knowledge about anxiety in ASD

    The primary objective is to improve the participants' and their parent/caregivers' knowledge of the presentation of anxiety in ASD management from pre- to post-intervention. This will be measured after 4 weeks of using the psychoeducation guide (this will be 4 weeks post-randomisation for the immediate start group and 8 weeks post-randomisation for the delayed start group).

    4 weeks of using the guide

Secondary Outcomes (2)

  • Anxiety symptoms

    4 weeks of using the guide

  • Acceptability, usefulness and appropriateness of the guide

    4 weeks of using the guide

Study Arms (2)

Immediate start

OTHER

This group receive the intervention (psychoeducation guide) immediately following baseline assessment and are assessed 4 and 8 weeks later.

Other: Psychoeducation

Delayed start

OTHER

This group do not receive the intervention for 4 weeks. They are assessed after the wait period (4 weeks) and again after 4 weeks of having the intervention (psychoeducation guide) at week 8.

Other: Psychoeducation

Interventions

PsychoeducationOTHER

The intervention is focused on psychoeducation. Four psychoeducation guides will be available: parent/caregiver, adult with ASD, adolescent with ASD, and child with ASD. The guides introduce the concept of anxiety and how it presents in individuals with ASD, different anxiety triggers, strategies that can be used to manage anxiety, and an introduction to specific anxiety disorders. Level of detail, language and presentation of content will vary across the guides to be appropriate for the functioning level of the readers.

Also known as: Self-help guide
Delayed startImmediate start

Eligibility Criteria

Age8 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • A diagnosis of ASD.
  • Elevated levels of anxiety according to baseline questionnaire measure (Screen for Anxiety Related Disorders; SCARED)
  • Have a parent/caregiver who is knowledgeable about participant's mental state and everyday activities and who can facilitate their use of the psychoeducation guide
  • Mental age of 8 years or older, the lowest age recommended to complete the standardised measure of anxiety.

You may not qualify if:

  • Participants or consultees, where relevant, who are unwilling to participate
  • Participants who do not have a reasonable level of English. This is because a reasonable level of English will be required to engage with the guide, which is presently written in English and the questionnaires and/or interview questions about the guide. With younger participants with ASD using the materials, English should be the language used at home and school.
  • Participants with any significant safeguarding concerns or involvement with court proceedings.
  • Participants who are due to commence or have a major change in psychological or pharmacological treatment for their anxiety at a similar time to being given the psychoeducation guide.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

South London and the Maudsley

London, SE5 8AF, United Kingdom

Location

Guy's and St Thomas' NHS trust

London, United Kingdom

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAnxiety Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Emily Simonoff, MD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2016

First Posted

June 13, 2016

Study Start

September 1, 2016

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

September 13, 2019

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)