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

NCT02721394 | Unknown

• 1 other identifier: ResGov 325
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

Intellectual Disability

Keywords

Challenging Behaviour; Functional Communication Training; Positive Behavioural Support; Family carer training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Observation of occurrence of communication

  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)

  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

  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)

  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)

  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 (1)

• Treatment Acceptability Rating Form - Revised (Reimers & Wacker, 1988)

  At final follow up session approximately 6 months after the beginning of the study.

Study Arms (3)

Researcher Implemented FCT

EXPERIMENTAL

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

Family Carer Implemented FCT 1

EXPERIMENTAL

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

Family Carer Implemented FCT 2

EXPERIMENTAL

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

Interventions

Functional Communication Training BEHAVIORAL

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

Family Carer Implemented FCT 1; Family Carer Implemented FCT 2; Researcher Implemented FCT

Eligibility Criteria

• Age: Up to 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Kent: lead

Study Sites (2)

East Kent Hospitals University NHS Foundation Trust

Canterbury, Kent, United Kingdom

Location

Mencap Northern Ireland

Belfast, BT8 6BT, United Kingdom

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 29, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 30, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)