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

NCT04714606 | Completed

• 1 other identifier: 260159
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Experience of Service Questionnaire (ESQ, Attride-Stirling, 2002)

  Post intervention (6 weeks after Time 1)

Study Arms (2)

Sibling support group

EXPERIMENTAL

8 session, tailored support group for siblings of children who have an ASD

Other: Sibling support group

Booklet

ACTIVE COMPARATOR

Control condition in which siblings of children who have an ASD will receive a tailored booklet to complete at home

Other: None - control condition

Interventions

Sibling support group OTHER

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

Sibling support group

None - control condition OTHER

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.

Booklet

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (1)

The Howard Partnership Multi-Academy Trust

Leatherhead, KT24 5JR, United Kingdom

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Lucy Ms Watson

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: January 19, 2021
• Study Start: December 14, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)