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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: Sibling support group; Other: None - control condition

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leatherhead, United Kingdom, KT24 5JR
    • The Howard Partnership Multi-Academy Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Surrey
• Investigators: Principal Investigator: Lucy Ms Watson, University of Surrey

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 260159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No