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The Development of a Psychoeducational Tool to Manage Anxiety in People With Autism Spectrum Disorders (MANAGE)

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ClinicalTrials.gov Identifier: NCT02797379
Recruitment Status : Unknown
Verified September 2016 by King's College London.
Recruitment status was:  Recruiting
First Posted : June 13, 2016
Last Update Posted : July 14, 2017
Sponsor:
Collaborators:
South London and Maudsley NHS Foundation Trust
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Anxiety Other: Psychoeducation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Development of a Psychoeducation Tool to Manage Anxiety in People With Autism Spectrum Disorders: the Managing Anxiety iN Autism GuidE (MANAGE)
Actual Study Start Date : September 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Immediate start
This group receive the intervention (psychoeducation guide) immediately following baseline assessment and are assessed 4 and 8 weeks later.
Other: Psychoeducation
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.
Other Name: Self-help guide

Delayed start
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
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.
Other Name: Self-help guide




Primary Outcome Measures :
  1. Knowledge about anxiety in ASD [ Time Frame: 4 weeks of using the guide ]
    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).


Secondary Outcome Measures :
  1. Anxiety symptoms [ Time Frame: 4 weeks of using the guide ]
    One secondary aim will be to determine whether use of the guide leads to a decrease in reported anxiety symptoms in the participant and their impact on everyday life. This will be measured pre and post intervention with the Screen for Anxiety Related Disorders.

  2. Acceptability, usefulness and appropriateness of the guide [ Time Frame: 4 weeks of using the guide ]
    In providing the participant and/or their parent/caregiver with the psychoeducation guide the research team will also seek feedback on acceptability, usefulness and appropriateness of the guide for each participant. This will be measured using newly developed feedback questionnaire.



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Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797379


Contacts
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Contact: Rachel Kent, PhD +44 (0)207 848 5368 rachel.kent@kcl.ac.uk
Contact: Sophie Carruthers, BA +44 (0)207 848 5369 sophie.carruthers@kcl.ac.uk

Locations
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United Kingdom
South London and the Maudsley Recruiting
London, United Kingdom, SE5 8AF
Contact: Emily Simonoff, MD, FRCPsych    02078485312    emily.simonoff@kcl.ac.uk   
Guy's and St Thomas' NHS trust Recruiting
London, United Kingdom
Contact: Ann Oszivadjian, DClin         
Sponsors and Collaborators
King's College London
South London and Maudsley NHS Foundation Trust
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Emily Simonoff, MD King's College London

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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02797379     History of Changes
Other Study ID Numbers: 200774
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by King's College London:
Psychoeducation
Self-help

Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Mental Disorders
Neurodevelopmental Disorders