Clinical trial NCT02721394: FCT With Young Children With ID in the UK: A Feasibility Project V.1
Official title: Conducting Functional Communication Training (FCT) With Young Children With Intellectual Disabilities in NHS Settings in the UK: A Feasibility Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intellectual Disability
Keywords: Challenging Behaviour
Functional Communication Training
Positive Behavioural Support
Family carer training
Lead sponsor: University of Kent
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 8
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current project aims to assess the feasibility of conducting Functional Communication Training in the UK with a small sample of young children (aged under 9) in an NHS setting. Three delivery formats will be assessed in order to demonstrate the feasibility of conducting FCT via different delivery methods within an NHS context. Participants will be four children aged under 9 who have an identified intellectual / developmental disability and display either self-injury, property destruction, or aggression at home. In addition, one family carer per child will be coached to implement the intervention, either following researcher intervention, or from the beginning. Data will be collected on challenging behaviour, communication responses, family carer confidence in managing behaviour, fidelity of intervention implementation, family quality of life, and acceptability of the intervention.


Eligibility criteria: Inclusion Criteria:

* Child aged under 9
* Child has identified intellectual disability or genetic syndrome associated with intellectual disability (e.g. Fragile X Syndrome)
* Child uses only phrase speech (i.e. 2-3 word utterances)
* Child displays self injury, aggression, property destruction at home
* Family carers aged over 18 with capacity to consent
* Family carer speaks English as first language (to ensure that the child understands English and will therefore understand researcher)

Exclusion Criteria:

* Child experiences health condition involving pain that is not well controlled by treatment
* Child is fully deaf / blind
* Child or family carer receiving active treatment in relation to child's behaviour (e.g. direct behavioural support, parenting programme etc.)

Primary outcomes:
measure: Observation of frequency or duration challenging behaviour
timeFrame: During functional analysis (2 sessions), intervention (4 sessions), maintenance (3 sessions) & follow up (1 session). Across a total of approximately 6 months.
Secondary outcomes:
measure: Observation of occurrence of communication
timeFrame: During intervention (4 sessions), maintenance (3 sessions), & follow up (1 session). Across a total of approximately 5 months.
measure: Beech Centre Family Quality of Life Scale (Park et al., 2003)
timeFrame: At beginning of study, immediately after intervention (approximately 6-8 weeks later), and at final follow up session (approximately 6 months after beginning of the study).
measure: Rating scale measuring intervention fidelity
timeFrame: During intervention sessions (4 sessions), maintenance sessions (3 sessions), and during follow up (1 session). Across a total of approximately 5 months.
measure: Modified Challenging Behaviour Checklist (Harris, Humphreys, & Thomson, 1994)
timeFrame: At beginning of study, immediately after intervention (approximately 6-8 weeks later), and at final follow up session (approximately 6 months after beginning of the study).
measure: Functional Assessment Interview Communication Section (O'Neill, Albin, Storey, Horner, & Sprague, 2014)
timeFrame: At beginning of study, immediately after intervention (approximately 6-8 weeks later), and at final follow up session (approximately 6 months after beginning of the study).
measure: Modified Parenting Task Checklist (Sanders & Woolley, 2001; 2005)
timeFrame: At beginning of study, immediately after intervention (approximately 6-8 weeks later), and at final follow up session (approximately 6 months after beginning of the study).
Other outcomes:
measure: Treatment Acceptability Rating Form - Revised (Reimers & Wacker, 1988)
timeFrame: At final follow up session approximately 6 months after the beginning of the study.
Locations:
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals University NHS Foundation Trust
state: Kent
city: Belfast
country: United Kingdom
facility: Mencap Northern Ireland
Study officials:
References: