Autism Spectrum DisorderNCT04714606
Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD
A study testing Sibling support group in people with Autism Spectrum Disorder, run by University of Surrey at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Sibling support group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Dec 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Howard Partnership Multi-Academy Trust
Leatherhead, KT24 5JR
About this study
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
- Being tested
- Sibling support group, None - control condition
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sibling support groupOther
The intervention is a novel, 8 session sibling support group which has been created for the purpose of the study.
None - control conditionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sibling support group | Experimental | 8 session, tailored support group for siblings of children who have an ASD Receives: 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 Receives: Other: None - control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre (Week 1) and post (Week 6) intervention
Secondary outcomes (1)
Experience of Service Questionnaire (ESQ, Attride-Stirling, 2002)
Questionnaire used to measure experience post intervention or control condition. Higher scores indicate better outcome.
Measured: Post intervention (6 weeks after Time 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start14 Dec 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucy Ms Watson, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714606
- Sponsor's protocol ID
- 260159
- Status last verified
- Jun 2021
- First submitted
- 9 Dec 2020
- Last updated
- 16 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD
- ClinicalTrials.gov ID
- NCT04714606
- Acronym / sponsor ID
- 260159
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sibling support group | Experimental | Other: Sibling support group8 session, tailored support group for siblings of children who have an ASD |
| Booklet | Active comparator | Other: None - control conditionControl condition in which siblings of children who have an ASD will receive a tailored booklet to complete at home |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sibling support groupThe intervention is a novel, 8 session sibling support group which has been created for the purpose of the study. | Other | Sibling support group |
| None - control conditionThe 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. | Other | Booklet |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Experience of Service Questionnaire (ESQ, Attride-Stirling, 2002)
Time frame: Post intervention (6 weeks after Time 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy Ms Watson principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sibling support group in people with Autism Spectrum Disorder, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Strengths & Difficulties Questionnaire (SDQ, Goodman et al., 2009) scores (time frame: Pre (Week 1) and post (Week 6) intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.