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Completed

NCT Number: NCT04714606

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Howard Partnership Multi-Academy Trust

Leatherhead, KT24 5JR, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sibling support group

Other

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

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.

Primary outcomes

  1. Change in Strengths & Difficulties Questionnaire (SDQ, Goodman et al., 2009) scores

    Time frame: Pre (Week 1) and post (Week 6) intervention

    Questionnaire used to measure effectiveness pre and post intervention or control condition. Lower scores indicate better outcome.

  2. Change in Paediatric Quality of Life Inventory (PedsQL V4.0; Varni, Seid & Kurtin, 2001) scores

    Time frame: Pre (Week 1) and post (Week 6) intervention

    Questionnaire used to measure effectiveness pre and post intervention or control condition. Higher scores indicate better outcome.

  3. Change in Knowledge of Autism Questionnaire (KAS; Ross & Cuskelly, 2006) scores

    Time frame: Pre (Week 1) and post (Week 6) intervention

    Questionnaire used to measure knowledge of autism pre and post intervention or control condition. Higher scores indicate better outcome.

  4. Change in Goal Based Outcomes (GBOs, Law & Jacob, 2015) scores Goal Based Outcomes (GBOs, Law & Jacob, 2015)

    Time frame: Pre (Week 1) and post (Week 6) intervention

    Questionnaire used to measure effectiveness pre and post intervention or control condition. Higher scores indicate better outcome.

Secondary outcomes

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

    Time frame: Post intervention (6 weeks after Time 1)

    Questionnaire used to measure experience post intervention or control condition. Higher scores indicate better outcome.

Sponsors and collaborators

Lead sponsor

University of Surrey

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2021
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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