Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have… (NCT04714606) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD
United Kingdom12 participantsStarted 2020-12-14
Plain-language 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.
Who can participate
Age range
7 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Strengths & Difficulties Questionnaire (SDQ, Goodman et al., 2009) scores
Timeframe: Pre (Week 1) and post (Week 6) intervention
2
Change in Paediatric Quality of Life Inventory (PedsQL V4.0; Varni, Seid & Kurtin, 2001) scores
Timeframe: Pre (Week 1) and post (Week 6) intervention
3
Change in Knowledge of Autism Questionnaire (KAS; Ross & Cuskelly, 2006) scores
Timeframe: Pre (Week 1) and post (Week 6) intervention
4
Change in Goal Based Outcomes (GBOs, Law & Jacob, 2015) scores Goal Based Outcomes (GBOs, Law & Jacob, 2015)
Timeframe: Pre (Week 1) and post (Week 6) intervention
. 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.