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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04714606
• Other study ID #: 260159
• Status: Completed
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Other:
• Sibling support group
The intervention is a novel, 8 session sibling support group which has been created for the purpose of the study.
• 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.

Locations

Country	Name	City	State
United Kingdom	The Howard Partnership Multi-Academy Trust	Leatherhead

Sponsors (1)

Lead Sponsor	Collaborator
University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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)