Back to resultsFeasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sibling support group
None - control condition
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- 7-11 years old.
- Must have a sibling who has a formal diagnosis of ASD.
- Must be competent in the English language.
- Must be in mainstream education.
- 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).
- Must be registered with a GP and parental consent gained to inform the GP that the sibling is attending the group.
Exclusion Criteria:
- If the sibling has a diagnosis of ASD themselves.
- 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).
- If the sibling is currently receiving any other psychological treatment.
- 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.
Sites / Locations
- The Howard Partnership Multi-Academy Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sibling support group
Booklet
Arm Description
8 session, tailored support group for siblings of children who have an ASD
Control condition in which siblings of children who have an ASD will receive a tailored booklet to complete at home
Outcomes
Primary Outcome Measures
Change in Strengths & Difficulties Questionnaire (SDQ, Goodman et al., 2009) scores
Questionnaire used to measure effectiveness pre and post intervention or control condition. Lower scores indicate better outcome.
Change in Paediatric Quality of Life Inventory (PedsQL V4.0; Varni, Seid & Kurtin, 2001) scores
Questionnaire used to measure effectiveness pre and post intervention or control condition. Higher scores indicate better outcome.
Change in Knowledge of Autism Questionnaire (KAS; Ross & Cuskelly, 2006) scores
Questionnaire used to measure knowledge of autism pre and post intervention or control condition. Higher scores indicate better outcome.
Change in Goal Based Outcomes (GBOs, Law & Jacob, 2015) scores Goal Based Outcomes (GBOs, Law & Jacob, 2015)
Questionnaire used to measure effectiveness pre and post intervention or control condition. Higher scores indicate better outcome.
Secondary Outcome Measures
Experience of Service Questionnaire (ESQ, Attride-Stirling, 2002)
Questionnaire used to measure experience post intervention or control condition. Higher scores indicate better outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04714606
Brief Title
Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD
Official Title
Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Surrey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A feasibility controlled trial 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. Due to the on-going impact of COVID-19 restrictions, children will be allocated to the intervention condition (eight session support group) if they are physically attending school and to the control condition (receipt of a booklet) if they remain at home. Pre and post outcome measures will be completed by children and their parents in both research arms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sibling support group
Arm Type
Experimental
Arm Description
8 session, tailored support group for siblings of children who have an ASD
Arm Title
Booklet
Arm Type
Active Comparator
Arm Description
Control condition in which siblings of children who have an ASD will receive a tailored booklet to complete at home
Intervention Type
Other
Intervention Name(s)
Sibling support group
Intervention Description
The intervention is a novel, 8 session sibling support group which has been created for the purpose of the study.
Intervention Type
Other
Intervention Name(s)
None - control condition
Intervention Description
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 Measure Information:
Title
Change in Strengths & Difficulties Questionnaire (SDQ, Goodman et al., 2009) scores
Description
Questionnaire used to measure effectiveness pre and post intervention or control condition. Lower scores indicate better outcome.
Time Frame
Pre (Week 1) and post (Week 6) intervention
Title
Change in Paediatric Quality of Life Inventory (PedsQL V4.0; Varni, Seid & Kurtin, 2001) scores
Description
Questionnaire used to measure effectiveness pre and post intervention or control condition. Higher scores indicate better outcome.
Time Frame
Pre (Week 1) and post (Week 6) intervention
Title
Change in Knowledge of Autism Questionnaire (KAS; Ross & Cuskelly, 2006) scores
Description
Questionnaire used to measure knowledge of autism pre and post intervention or control condition. Higher scores indicate better outcome.
Time Frame
Pre (Week 1) and post (Week 6) intervention
Title
Change in Goal Based Outcomes (GBOs, Law & Jacob, 2015) scores Goal Based Outcomes (GBOs, Law & Jacob, 2015)
Description
Questionnaire used to measure effectiveness pre and post intervention or control condition. Higher scores indicate better outcome.
Time Frame
Pre (Week 1) and post (Week 6) intervention
Secondary Outcome Measure Information:
Title
Experience of Service Questionnaire (ESQ, Attride-Stirling, 2002)
Description
Questionnaire used to measure experience post intervention or control condition. Higher scores indicate better outcome.
Time Frame
Post intervention (6 weeks after Time 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
7-11 years old.
Must have a sibling who has a formal diagnosis of ASD.
Must be competent in the English language.
Must be in mainstream education.
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).
Must be registered with a GP and parental consent gained to inform the GP that the sibling is attending the group.
Exclusion Criteria:
If the sibling has a diagnosis of ASD themselves.
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).
If the sibling is currently receiving any other psychological treatment.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy Ms Watson
Organizational Affiliation
University of Surrey
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Howard Partnership Multi-Academy Trust
City
Leatherhead
ZIP/Postal Code
KT24 5JR
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD
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