Clinical and Cost Effectiveness of Positive Behaviour Support: a Trial

NCT01680276 | Unknown Phase 3 DMC

• 1 other identifier: 10/104/13
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 3

Brief Summary

Many people with intellectual disability have challenging behaviour which often has serious consequences such as the prescription of long term medication, in-patient admissions and disruption of normal daily activities. Community intellectual disability services may have difficulties in helping people with challenging behavior. Available research suggests that Positive Behavior Support (PBS), a training system that teaches staff how to manage these situations, can benefit service users who may show improvements in challenging behavior and quality of life. The investigators do not know of any study so far that has examined the clinical and cost effectiveness of PBS that is provided by staff in routine clinical practice in community intellectual disability services. If PBS proved to be better than treatment as usual, it would have important implications for the management of a very vulnerable group of service users. In this trial, health staff will receive accredited training in PBS available in a manual written by PBS experts. It will give details of how to understand challenging behavior and develop a management plan and how to implement it and monitor whether it has achieved its goals. Twenty community intellectual disability services and 260 service users with mild to severe intellectual disability and challenging behavior will be invited to take part in the study. The sample size calculations are based on our pilot study and allow for non participation of 10% and inflation due to the number of community intellectual disability teams and staff that will take part. The teams will be randomly allocated into one of two conditions. Half will be in the PBS arm (but will also have treatment as usual) and half will be in the treatment as usual only group. The investigators will carry out assessments of challenging behavior, use of services, quality of life, mental health, aggression and family and paid carer burden at six and 12 months. The investigators will monitor treatment fidelity and the investigators will talk to a sample of paid and family carers, service users, staff and managers about what they think of the treatment and how best the investigators can deliver it in routine care. The main outcome is reduction in challenging behavior at one year after the randomization. The investigators will also carry out a health economic evaluation to examine the costs and consequences of staff training in PBS.

Conditions

Challenging Behaviour

Keywords

intellectual disability; developmental disability; challenging behaviour; behavioural intervention; training

Outcome Measures

Primary Outcomes (1)

• Challenging Behaviour

  Reduction in challenging behaviour as measured by the Aberrant Behaviour Checklist (ABC)and change from baseline and 6 months

  12 months

Secondary Outcomes (5)

• Quality of life

  12 months

• Mental health status

  12 months

• Family carer burden

  12 months

• Paid carer burden

  12 months

• Family Carer Psychiatric Morbidity

  12 months

Other Outcomes (3)

• Cost effectiveness

  12 months

• Community participation

  6 months

• Community participation

  12 months

Study Arms (2)

PBS based staff training

EXPERIMENTAL

The training, which will be supported by a treatment manual will comprise the following sections: 1. Functional Behavioural Assessment and formulation skills • Brief Behavioural Assessment Tool for brief functional analyses 2. Primary Prevention 3. Secondary Prevention and Reactive Strategies 4. Periodic Service Review and Problem Solving * Developing individualised periodic service reviews * Trouble shooting

Behavioral: PBS based staff training; Other: Treatment as Usual

Treatment as usual

OTHER

Most community intellectual disability services provide a range of health interventions that include but are not limited to psychiatric assessment and management, nursing support, psychology, speech and language therapy, occupational therapy and counselling. There may be some variation in resources but service users with challenging behaviour are likely to receive a range of broadly defined behavioural management and pharmacological interventions. Staff is routinely supervised by their clinical managers weekly.

Other: Treatment as Usual

Interventions

PBS based staff training BEHAVIORAL

Please see published study protocol for more information: http://www.biomedcentral.com/1471-244X/14/219

PBS based staff training

Treatment as Usual OTHER

http://www.biomedcentral.com/1471-244X/14/219

PBS based staff training; Treatment as usual

Eligibility Criteria

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

You may qualify if:

• Service users: Eligible to receive care from intellectual disability services; mild to severe intellectual disability; aged 18 years and over; total ABC score of at least 15 (indicates a degree of challenging behaviour occurring at least weekly including verbal or physical aggression, hyperactivity, refusal to attend activities, non responsiveness that requires professional input).
• Service: Willing to participate; availability of at least two staff members willing to train; written agreement by the service manager to participate.

You may not qualify if:

• Service users: primary clinical diagnosis of personality disorder or substance misuse; relapse in pre-existing mental disorder; decision by clinical team that a referral to the study would be inappropriate, e.g. there is an open complaint investigation
• Service: there are no team members willing to train; the service has already received and implements accredited PBS for their service users.

Sponsors & Collaborators

• University College, London: lead

Study Sites (3)

Leicestershire Foundation Trust

Leicester, United Kingdom

Location

Camden & Islington Foundation Trust

London, United Kingdom

Location

South London and St George's Mental Health Trust

London, United Kingdom

Location

Related Publications (5)

• Hassiotis A, Strydom A, Crawford M, Hall I, Omar R, Vickerstaff V, Hunter R, Crabtree J, Cooper V, Biswas A, Howie W, King M. Clinical and cost effectiveness of staff training in Positive Behaviour Support (PBS) for treating challenging behaviour in adults with intellectual disability: a cluster randomised controlled trial. BMC Psychiatry. 2014 Aug 3;14:219. doi: 10.1186/s12888-014-0219-6.

  PMID: 25927187 BACKGROUND

• Strydom A, Bosco A, Vickerstaff V, Hunter R; PBS study group; Hassiotis A. Clinical and cost effectiveness of staff training in the delivery of Positive Behaviour Support (PBS) for adults with intellectual disabilities, autism spectrum disorder and challenging behaviour - randomised trial. BMC Psychiatry. 2020 Apr 15;20(1):161. doi: 10.1186/s12888-020-02577-1.

  PMID: 32293383 DERIVED

• Hunter RM, Vickerstaff V, Poppe M, Strydom A, King M, Hall I, Crabtree J, Omar R, Cooper V, Biswas A, Hassiotis A. Staff training in positive behaviour support for behaviour that challenges in people with intellectual disability: cost-utility analysis of a cluster randomised controlled trial. BJPsych Open. 2020 Feb 5;6(2):e15. doi: 10.1192/bjo.2020.1.

  PMID: 32019635 DERIVED

• Hassiotis A, Poppe M, Strydom A, Vickerstaff V, Hall I, Crabtree J, Omar R, King M, Hunter R, Bosco A, Biswas A, Ratti V, Blickwedel J, Cooper V, Howie W, Crawford M. Positive behaviour support training for staff for treating challenging behaviour in people with intellectual disabilities: a cluster RCT. Health Technol Assess. 2018 Mar;22(15):1-110. doi: 10.3310/hta22150.

  PMID: 29596045 DERIVED

• Hassiotis A, Poppe M, Strydom A, Vickerstaff V, Hall IS, Crabtree J, Omar RZ, King M, Hunter R, Biswas A, Cooper V, Howie W, Crawford MJ. Clinical outcomes of staff training in positive behaviour support to reduce challenging behaviour in adults with intellectual disability: cluster randomised controlled trial. Br J Psychiatry. 2018 Mar;212(3):161-168. doi: 10.1192/bjp.2017.34. Epub 2018 Feb 12.

  PMID: 29436314 DERIVED

Related Links

• Published protocol in open access journal

MeSH Terms

Conditions

Intellectual Disability; Developmental Disabilities

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Andre Strydom, MD PhD

  UCL

  STUDY DIRECTOR

• Ian Hall, MBBS MPhil

  East London Foundation Trust

  STUDY DIRECTOR

• Michael King, FRCGP PhD

  UCL

  STUDY DIRECTOR

• Rumana Omar

  UCL Statistics

  STUDY DIRECTOR

• Rachael Hunter

  Health Economist

  STUDY DIRECTOR

• Vivien Cooper

  Challenging Behaviour Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: September 7, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2016
• Last Updated: May 23, 2016

Record last verified: 2015-06

Locations

GB (3)