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Complex Neurodevelopmental DisorderENCOMPASSNCT06310681

Pilot Testing of a Co-adapted Group Programme for Parents/Carers of Children With Complex Neurodisability

A study testing "Encompass" group programme in people with Complex Neurodevelopmental Disorder and Cerebral Palsy, run by City, University of London at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
"Encompass" group programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesUnited Kingdom
Study dates
6 Jun 2024to 1 Apr 2025
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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
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  • Therapists or healthcare professionals who work with children with disabilities and who are open to learning with families about their children.
  • Need to be registered with the Health and Care Professionals Council and should ideally have > 5 years post-graduate experience working with a paediatric population
  • Confident in working with children with complex neurodisability, such as cerebral palsy
  • Staff from the NHS that are either involved in the delivery or commissioning of community child health care services in Newham or Tower Hamlets.
  • Examples include clinical managers, service leads or commissioners.

Who cannot join

  • 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.
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  • Parent Facilitator:
  • Inability to read and speak English
  • Inability to commit to a 6-month period of work to the best of their knowledge
  • Healthcare Professional Facilitator:
  • Inability to read and speak English
  • Inability to commit to a 6-month period of work to the best of their knowledge
  • Key Stakeholders:
  • None

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Barts Health NHS Trust, Children's Occupational Therapy, Mile End Hospital

    London, E1 4EH

  • East London NHS Foundation Trust, Specialist Children's and Young People's Services

    London, E15 4PT

Other trials in United Kingdom

About this study

Official title: A Co-adapted Community-based Participatory Group Programme for Parents/Carers of Children With Complex Neurodisability (ENCOMPASS): A Pilot and Feasibility Study

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:

Read more
  • 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.

Read the detailed description

Background

Parents/carers of children with complex neurodisability continue to lack appropriate family-centred care. "Encompass" is a community-based group programme that was co-adapted from "Baby Ubuntu" in Uganda. It is an example of a 'decolonised healthcare innovation' as it is a low-cost solution from a low-income country for use in a resource-constrained UK National Health Service (NHS).

Methods and analysis

The investigators will conduct a mixed methods pilot feasibility study to determine the feasibility and acceptability of delivering and evaluating "Encompass" with parents/carers of children under 5 years with complex neurodisability in the UK. The investigators aim to recruit 20 parents/carers of children from two NHS trusts in England serving urban areas where there is high social deprivation and ethnic diversity. Recruited parents/carers will attend the 10-modular, participatory group programme over a 6-month period. Groups will be facilitated by a trained allied health professional and an 'expert parent' with lived experience. The primary outcomes of interest are the feasibility of delivering and evaluating the programme (recruitment, retention rates, acceptability as perceived by the parents/carers, facilitators and wider key stakeholders), intervention fidelity and participant adherence. Results will be collectively assessed against traffic light criteria. Pre-, post- and follow-up data collection questionnaires will include the Family Empowerment Scale (FES), the Power Ladder Question, the Parent Patient Activation Measure (P-PAM), Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), EuroQoL-5D-5-level (EQ-5D-5L) and parent/carer greatest needs and goals questionnaire. Post-intervention semi-structured interviews will be conducted with parents/carers, facilitators and key stakeholders within the NHS.

Discussion

Providing family-centred support through a community-based participatory group programme is a potentially affordable and sustainable way for the NHS to improve a range of outcomes for parents/carers of children with complex neurodisability including knowledge, skills and confidence, wellbeing and quality of life. The programme also provides opportunities for peer support and aims to empower parents/carers in navigating community health systems.

Being tested
"Encompass" group programme
Keywords
Community-based programme, cerebral palsy, caregiver, parent, peer support, feasibility, acceptability, children, complex neurodisability
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "Encompass" group programmeBehavioural

    • Groups will take place over ten modules
    • They will take place in-person at a local community venue
    • The groups will be two hours long, with a break for refreshments in the middle. They will take place every fortnight in term-time only over approximately 6 months.
    • The groups predominantly follow a participatory learning approach and although the facilitators have manuals, the activities tend to include some imparting of information, key points for discussion, examples from other settings and activities for the group to practice.
    • They are run by two facilitators - one parent with lived experience and one healthcare professional
Study groups in NCT06310681
Study groupRoleWhat they receive
"Encompass" group programmeExperimentalNot described
Receives: Behavioral: "Encompass" group programme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Group Attendance

    Green light - More than 80% of parents/carers attend the group for 6+ sessions Amber light - 30-79% of parents/carers attend the group for 6+ sessions Red light - Fewer than 30% attend the group for 6+ sessions

    Feasibility, acceptability, and process outcome measures will be used. Quantitative data will be collected to assess the Traffic Light criteria. The green light signifies that criteria for progression has been met and a larger evaluation could proceed, the amber light suggests certain amendments need to be made and the red light indicates that the criteria for progression have not been met and researchers should not continue to a trial.

    Measured: End of each group, 6 months

  2. Recruitment - percentage of eligible participants who consent to take part

    Green light - 35% who are eligible consent to participate Amber light - 15-34% who are eligible consent to participate Red light - Less than 15% who are eligible consent to participate

    Measured: Before the groups commence, 3 months

  3. Follow-up response rate-self-complete outcomes questionnaire(s)

    Green light - 70% or greater response to follow up Amber light - 50-69% response to follow up Red light - Less than 50% response to follow up

    Measured: Through the groups and 3 months post-groups, approximately 9 months

  4. Fidelity - delivery on items described in the Fidelity Checklist

    Green light - 70% or greater score on the checklist Amber light - 50-69% score on the checklist Red light - Less than 50% score on the checklist

    Measured: End of each group, 6 months

Secondary outcomes (7)

  1. Family Empowerment Scale (FES)

    The Family Empowerment Scale (FES) is a validated 24-item instrument that measures parents' sense of empowerment across three areas; family, service use and community. It has been used in the ENVISAGE (ENabling VISions And Growing Expectations) parent workshops and aligns with the goals of the 'Encompass' groups which are to empower families to understand their child's diagnosis and how to navigate health systems. A limitation of this tool is that it has mostly been used with a white, US population.

    Measured: First and final groups, 6 months

  2. Power Ladder Question (PLQ)

    The Power Ladder Question (PLQ) assesses participants' perceived sense of power and influence over their life. The survey asks "Please imagine a nine-step ladder, where on the bottom, the first step, stand people who are completely without rights, and on the highest step, the ninth, stand those who have a lot of power. On which step are you?". It has been used with diverse groups and allows the participant to choose the domains of power that they value, and interpret the question openly.

    Measured: First and final groups, 6 months

  3. Parent Patient Activation Measure (P-PAM)

    Parent patient activation relates to the knowledge, skills, confidence and persistence to manage a child's health care, particularly those with developmental disorders or disabilities. The Parent-Patient Activation Measure (P-PAM) is a validated 13-item tool that measures two factors; 'confidence and knowledge' and 'action and perseverance' . It has been used in a variety of diverse settings, including low income, non-English speaking parents.

    Measured: First and final groups, 6 months

  4. Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

    The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) has been widely used to assess wellbeing across a diverse range of public health interventions, populations, and settings. The 14-item scale WEMWBS will be used with 5 response categories that are summed up to provide a single score.

    Measured: First and final groups, 6 months

  5. Parent/carer Quality of Life - EuroQoL-5D-5-level (EQ-5D-5L)

    The EuroQoL five-dimension questionnaire is a validated and widely used tool that measures generic quality of life. It has one question for each of the five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with five response options

    Measured: First and final groups, 6 months

  6. Parent/carer Needs and Goals

    A questionnaire has been adapted from previous evaluations of Ubuntu interventions. It has two questions and asks parents/carers what their three biggest issues are that they face in everyday life, and what their two main goals are for attending the group.

    Measured: First group, 1 month

  7. Childhood Cost Calculator (C3)

    A costing tool for education and early childhood development.

    Measured: End of study, 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start6 Jun 2024
  3. Primary completion1 Mar 2025
  4. Study completion1 Apr 2025

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06310681
Sponsor's protocol ID
ETH2223-2528
Acronym
ENCOMPASS
Status last verified
Apr 2026
First submitted
27 Feb 2024
Last updated
9 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Prest K, Barnicot K, Hurt C, Tann CJ, Heys M, Harden A. Feasibility of an Adapted Participatory Group Programme for Caregivers of Children With Complex Neurodisability in the United Kingdom: Results From the Encompass-2 Study. Health Expect. 2026 Aug;29(4):e70767. doi: 10.1111/hex.70767.

    PubMed 42437489

  • Prest K, Harden A, Barnicot K, Heys M. A coadapted community-based participatory group programme for parents/carers of children with complex neurodisability (Encompass-2): a pilot and feasibility study protocol. Pilot Feasibility Stud. 2025 May 3;11(1):59. doi: 10.1186/s40814-025-01619-3.

    PubMed 40319319

Questions about this trial

What is this clinical trial studying?

A study testing "Encompass" group programme in people with Complex Neurodevelopmental Disorder and Cerebral Palsy, run by City, University of London at 2 sites 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 11 inclusion and 14 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 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Group Attendance (time frame: End of each group, 6 months). 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?

On the ClinicalTrials.gov record for NCT06310681, which also lists 2 linked publications.

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 9 Apr 2026.

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