FCT With Young Children With ID in the UK: A Feasibility Project V.1

Intellectual Disability Clinical Trial

Official title:

Conducting Functional Communication Training (FCT) With Young Children With Intellectual Disabilities in NHS Settings in the UK: A Feasibility Project

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02721394
• Other study ID #: ResGov 325
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 29, 2016
• Last updated: January 26, 2018
• Start date: February 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: University of Kent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 8
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 9 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Intellectual Disability

Intervention

Behavioral:
• Functional Communication Training
Functional Communication Training (which aims to teach the child a communicative alternative to challenging behaviour) implemented by either the researcher or family carer.

Locations

Country	Name	City	State
United Kingdom	Mencap Northern Ireland	Belfast
United Kingdom	East Kent Hospitals University NHS Foundation Trust	Canterbury	Kent

Sponsors (1)

Lead Sponsor	Collaborator
University of Kent

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Acceptability Rating Form - Revised (Reimers & Wacker, 1988)	Questionnaire assessing the acceptability of the intervention to family carers.	At final follow up session approximately 6 months after the beginning of the study.
Primary	Observation of frequency or duration challenging behaviour	Observational measure of the frequency or duration of child target behaviours. This measure is expected to show a change over time as the intervention progresses, therefore data is collected during every session.	During functional analysis (2 sessions), intervention (4 sessions), maintenance (3 sessions) & follow up (1 session). Across a total of approximately 6 months.
Secondary	Observation of occurrence of communication	Observational measure of the frequency of the child's use of the alternative communication response. This measure is expected to show a change over the course of the intervention and data will therefore be collected during each session.	During intervention (4 sessions), maintenance (3 sessions), & follow up (1 session). Across a total of approximately 5 months.
Secondary	Beech Centre Family Quality of Life Scale (Park et al., 2003)	Questionnaire evaluating family quality of life. This measure is expected to show a change over time as the intervention progresses, therefore data is collected at 3 time points (pre intervention, post intervention, and at final follow up).	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).
Secondary	Rating scale measuring intervention fidelity	Individualised rating scales assessing fidelity of researcher or family carer implementation of the intervention.	During intervention sessions (4 sessions), maintenance sessions (3 sessions), and during follow up (1 session). Across a total of approximately 5 months.
Secondary	Modified Challenging Behaviour Checklist (Harris, Humphreys, & Thomson, 1994)	Questionnaire to assess changes in non-targeted behaviours. This measure is expected to show a change over time as the intervention progresses, therefore data is collected at 3 time points (pre intervention, post intervention, and at final follow up).	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).
Secondary	Functional Assessment Interview Communication Section (O'Neill, Albin, Storey, Horner, & Sprague, 2014)	Questionnaire used to assess changes in non-targeted areas of communication. This measure is expected to show a change over time as the intervention progresses, therefore data is collected at 3 time points (pre intervention, post intervention, and at final follow up).	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).
Secondary	Modified Parenting Task Checklist (Sanders & Woolley, 2001; 2005)	Questionnaire to assess family carer confidence in doing a range of activities with their child. This measure is expected to show a change over time as the intervention progresses, therefore data is collected at 3 time points (pre intervention, post intervention, and at final follow up).	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).