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Feasibility RCT of an 8-session Group Intervention for Siblings of Children Who Have ASD

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ClinicalTrials.gov Identifier: NCT04714606
Recruitment Status : Recruiting
First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
University of Surrey

Brief Summary:

A Feasibility Randomized Controlled Trial (RCT) of an eight-session group intervention for siblings of children who have an Autism Spectrum Disorder (ASD).

Children will be recruited from a multi-academy trust of nine schools. They will be randomly allocated by school (due to COVID-19 restrictions) to the two research arms. Half will receive a tailored booklet to complete at home and the other half will attend a tailored support group for siblings of children who have an ASD. Pre and post outcome measures will be completed by children and their parents in both research arms.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Other: Sibling support group Other: None - control condition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Supporting Those Who Have A Relative Experiencing Autism Spectrum Disorders (SHARE-ASD): Feasibility RCT of an 8-session Group Intervention for Siblings of Children Who Have ASD
Actual Study Start Date : December 14, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sibling support group
8 session, tailored support group for siblings of children who have an ASD
Other: Sibling support group
The intervention is a novel, 8 session sibling support group which has been created for the purpose of the study.

Active Comparator: Booklet
Control condition in which siblings of children who have an ASD will receive a tailored booklet to complete at home
Other: None - control condition
The second arm of the study is a control condition in which participants will be given a tailored booklet to complete at home as it was deemed unethical to provide them with nothing.




Primary Outcome Measures :
  1. Change in Strengths & Difficulties Questionnaire (SDQ, Goodman et al., 2009) scores [ Time Frame: Pre (Week 1) and post (Week 6) intervention ]
    Questionnaire used to measure effectiveness pre and post intervention or control condition. Lower scores indicate better outcome.

  2. Change in Paediatric Quality of Life Inventory (PedsQL V4.0; Varni, Seid & Kurtin, 2001) scores [ Time Frame: Pre (Week 1) and post (Week 6) intervention ]
    Questionnaire used to measure effectiveness pre and post intervention or control condition. Higher scores indicate better outcome.

  3. Change in Goal Based Outcomes (GBOs, Law & Jacob, 2015) scores Goal Based Outcomes (GBOs, Law & Jacob, 2015) [ Time Frame: Pre (Week 1) and post (Week 6) intervention ]
    Questionnaire used to measure effectiveness pre and post intervention or control condition. Higher scores indicate better outcome.

  4. Change in Sibling's Views Questionnaire (SVQ, Gettings et al., 2015) scores [ Time Frame: Pre (Week 1) and post (Week 6) intervention ]
    Questionnaire used to measure effectiveness pre and post intervention or control condition. Higher scores indicate better outcome.


Secondary Outcome Measures :
  1. Experience of Service Questionnaire (ESQ, Attride-Stirling, 2002) [ Time Frame: Post intervention (6 weeks after Time 1) ]
    Questionnaire used to measure experience post intervention or control condition. Higher scores indicate better outcome.



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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 7-11 years old.
  2. Must have a sibling who has a formal diagnosis of ASD.
  3. Must be competent in the English language.
  4. Must be in mainstream education.
  5. Must be willing and able to engage in an eight-session group intervention (including being accompanied to and from the group by their parents/carers).
  6. Must be registered with a GP and parental consent gained to inform the GP that the sibling is attending the group.

Exclusion Criteria:

  1. If the sibling has a diagnosis of ASD themselves.
  2. If there are any clear risk concerns (e.g. any thought or intent to harm self or others, involvement in court proceedings or with the criminal justice system).
  3. If the sibling is currently receiving any other psychological treatment.
  4. If the sibling has a learning disability or difficulty that will make it hard to access the group content and/or capacity to provide informed consent.

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): NCT04714606


Contacts
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Contact: Lucy Watson 01483689441 l.r.watson@surrey.ac.uk
Contact: Christina Dr Jones c.j.jones@surrey.ac.uk

Locations
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United Kingdom
The Howard Partnership Multi-Academy Trust Recruiting
Leatherhead, United Kingdom, KT24 5JR
Contact: Lucy Ms Watson, BSc; currently DClinPsych Y3         
Sponsors and Collaborators
University of Surrey
Investigators
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Principal Investigator: Lucy Ms Watson University of Surrey
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Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT04714606    
Other Study ID Numbers: 260159
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
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
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders