Pilot Testing of a Co-adapted Group Programme for Parents/Carers of Children With Complex Neurodi… (NCT06310681) | Clinical Trial Compass
CompletedNot Applicable
Pilot Testing of a Co-adapted Group Programme for Parents/Carers of Children With Complex Neurodisability
United Kingdom15 participantsStarted 2024-06-06
Plain-language summary
The goal of this pilot feasibility study is to test a co-adapted community-based group programme ("Encompass") with parents/carers of children with complex neurodisability under 5 years of age in East London in the UK.
The main questions it aims to answer are:
* Is it feasible and acceptable to carry out this newly co-adapted programme with two groups of parents/carers of children with complex neurodisability under the age of 5?
* Is it feasible to carry out an evaluation of the above programme, which could then inform a protocol for larger scale evaluation?
The main activities for the parent/carer participants will include:
* Attending ten "Encompass" parent/carer groups
* Filling in questionnaires at the start and end of the groups
* Attending an interview with the researcher to discuss their experiences
The groups will be facilitated by a healthcare professional and a parent with lived experience. They will also be interviewed about their experiences after the groups have been completed.
Who can participate
Age range
18 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.
Parents and carers:
Inclusion Criteria:
* Care for a child (\<5 years) with a complex neurodisability\*
* Have received a diagnosis for their child, which has been disclosed to them, even this is a diagnosis such as SWAN (Syndrome Without A Name)
* Reside in the boroughs of Newham or Tower Hamlets, East London
* ≥18 years of age.
Exclusion Criteria:
* Have a child with a developmental disability where there are no functional physical impairments as part of their complex needs. For example, children diagnosed with Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, intellectual impairments will be excluded unless they have a functional physical impairment with a neurological cause too.
* Have a child with a progressive neurological condition such as Duchenne's Muscular Dystrophy.
* Have a child with a structural physical impairment not caused by a neurological event or neurological difficulties. For example, children born with a limb difference or a child with hearing loss.
* Do not have capacity to consent
* Do not meet the inclusion criteria as specified above
* There are no exclusions based on language, as interpreting/translating services will be offered.
Parent Facilitator:
Inclusion Criteria:
* Parents/carer of children with complex neurodisability who are identified through other services as potentially being able to facilitate a group as an 'expert parent'
* Prior experience in training or using participatory approaches - not essential
Exclusion…
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
Group Attendance
Timeframe: End of each group, 6 months
2
Recruitment - percentage of eligible participants who consent to take part