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

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

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.

Study Overview

• Status: Unknown
• Conditions: Intellectual Disability
• Intervention / Treatment: Behavioral: Functional Communication Training

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom, BT8 6BT
    • Mencap Northern Ireland
  • Kent
    • Canterbury, Kent, United Kingdom
      • East Kent Hospitals University NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Researcher Implemented FCT; Children receive functional communication training. Assessment and initial intervention sessions are completed by the researcher and family carers are trained to continue the intervention at home.	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.
Experimental: Family Carer Implemented FCT 1; Children receive functional communication training. Family carers are trained to implement all sessions (including assessment and initial intervention sessions) with coaching from the researcher in person.	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.
Experimental: Family Carer Implemented FCT 2; Children receive functional communication training. Family carers are trained to implement all sessions (including assessment and initial intervention sessions) with coaching from the researcher via videoconferencing and support from a family carer assistant in person.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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).
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.
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).
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).
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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Kent

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 29, 2016
• First Submitted That Met QC Criteria: March 28, 2016
• First Posted (Estimate): March 29, 2016

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Challenging Behaviour; Functional Communication Training; Positive Behavioural Support; Family carer training
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Intellectual Disability
• Other Study ID Numbers: ResGov 325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No