Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Clinical and Cost Effectiveness of Staff Training in Positive Behaviour Support (PBS) for Treating Challenging Behaviour in People With Intellectual Disability: A Cluster Randomised Controlled Trial
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.


Options:
A: Arm Label: Cognitus and Me; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive remediation program | Arm Label: control group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive remediation program | Intervention Type: BEHAVIORAL; Name: Cognitive remediation program; Assigned to Arm(s): Cognitus and Me, control group
B: Arm Label: Stepping Stones Triple P; Type: EXPERIMENTAL; Interventions: Behavioral: Level 4 Stepping Stones Triple P (SSTP) | Arm Label: Treatment as usual (TAU); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Level 4 Stepping Stones Triple P (SSTP); Assigned to Arm(s): Stepping Stones Triple P
C: Arm Label: PBS based staff training; Type: EXPERIMENTAL; Interventions: Behavioral: PBS based staff training, Other: Treatment as Usual | Arm Label: Treatment as usual; Type: OTHER; Interventions: Other: Treatment as Usual | Intervention Type: BEHAVIORAL; Name: PBS based staff training; Assigned to Arm(s): PBS based staff training | Intervention Type: OTHER; Name: Treatment as Usual; Assigned to Arm(s): PBS based staff training, Treatment as usual
D: Arm Label: Irritable youth; Type: N/A; Interventions: N/A

Answer: C