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

NCT06310681 | Completed

• 1 other identifier: ETH2223-2528
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cerebral Palsy; Complex Neurodevelopmental Disorder

Keywords

Community-based programme; cerebral palsy; caregiver; parent; peer support; feasibility; acceptability; children; complex neurodisability

Outcome Measures

Primary Outcomes (4)

• 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.

  End of each group, 6 months

• 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

  Before the groups commence, 3 months

• 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

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

• 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

  End of each group, 6 months

Secondary Outcomes (7)

• Family Empowerment Scale (FES)

  First and final groups, 6 months

• Power Ladder Question (PLQ)

  First and final groups, 6 months

• Parent Patient Activation Measure (P-PAM)

  First and final groups, 6 months

• Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

  First and final groups, 6 months

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

  First and final groups, 6 months

Study Arms (1)

"Encompass" group programme

EXPERIMENTAL

Behavioral: "Encompass" group programme

Interventions

"Encompass" group programme BEHAVIORAL

* 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

"Encompass" group programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Parent Facilitator:
• 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
• 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:
• 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
• Inability to read and speak English
• Inability to commit to a 6-month period of work to the best of their knowledge

Sponsors & Collaborators

• City, University of London: lead

Study Sites (2)

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

London, E1 4EH, United Kingdom

Location

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

London, E15 4PT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40319319 DERIVED

Related Links

• Encompass Study website

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 15, 2024
• Study Start: June 6, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

GB (2)