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

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Other: Sibling support group
* Other: None - control condition


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sibling support group<br>8 session, tailored support group for siblings of children who have an ASD | Other: Sibling support group<br>* The intervention is a novel, 8 session sibling support group which has been created for the purpose of the study.<br>|
| Active Comparator: Booklet<br>Control condition in which siblings of children who have an ASD will receive a tailored booklet to complete at home | Other: None - control condition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre (Week 1) and post (Week 6) intervention | 
| 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. | Pre (Week 1) and post (Week 6) intervention | 
| 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. | Pre (Week 1) and post (Week 6) intervention | 
| 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. | Pre (Week 1) and post (Week 6) intervention | 

Secondary Outcome Measures

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