This trial is active, not recruiting.

Condition child behavior
Treatments visual scheduling, signalling change
Phase phase 1
Sponsor Queen's University, Belfast
Collaborator University of Warwick
Start date January 2015
End date November 2016
Trial size 80 participants
Trial identifier NCT02567357, R2149PSY


'PREDICTORS' (Parents Resources for Decreasing the Incidence of Change Triggered Temper Outbursts) aims to evaluate web-based training packages for caregivers of children who show frequent temper outbursts following changes to their routines and plans. The training packages will teach caregivers how to apply strategies that aim to reduce the number of temper outbursts that the children show following changes, as well as making any outbursts they do show less severe (less functionally impairing).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Active Comparator)
A caregiver training package on the use of a pictorial (visual) schedule to illustrate each day's expected activities to a child. Caregivers will be trained to ensure that activities occur as described in the schedule as far as possible, thus the expected mechanism of action is the reduction of (unexpected change) antecedents of children's temper outbursts.
visual scheduling antecedent manipulation
Caregivers will present a visual schedule with pictorial representations of activities/events expected to occur each day will be presented to children at set times of day (tailored for individual's schedules). Ultimately caregivers will aim to ensure that activities occur as per the schedule as far as possible - thus decreasing the child's level of exposure to unexpected changes in routines or plans.
A caregiver training package where parents are taught to present a distinctive visual-verbal cue to a child whenever they become aware that a change will take place in the child's usual/expected activities. Caregivers will be trained to only ever present to cue if they can be sure that a change to the child's routine or plan will occur, thus the expected mechanism of action is the child's learned association between the presentation of the cue and the subsequent occurrence of a change to their expectations. Signalled changes will therefore be more predictable for the child, and should therefore be easier for them to deal with.
signalling change cuing change
Caregivers will present a distinct visual-verbal cue card whenever they become aware that a change to the child's routine or plan is about to occur. Thus, the intervention uses a stimulus control approach so that the child learns that presentation of the cue reliably predicts the subsequent occurrence of a change to routine/plan, and the change is therefore more predictable and easier for the child to deal with.

Primary Outcomes

Change in frequency of temper outbursts between baseline and intervention
time frame: 6 months baseline, 6 months during intervention
Change in percentage of changes to routines/plans experienced by children that are followed by temper outbursts between baseline and intervention
time frame: 6 months baseline, 6 months during intervention

Secondary Outcomes

Change in cost of services with which the child engages - Cost of Services Receipt Inventory
time frame: within 2 weeks before baseline, within one month after baseline, within one month following intervention
Process information on how the intervention strategies are being implemented by caregivers
time frame: every three days for 7 months from after baseline onwards

Eligibility Criteria

Male or female participants from 7 years up to 16 years old.

Inclusion Criteria: - children aged 7-16 years of age, with temper outbursts triggered by change to routine or plans and their parent(s)/caregiver(s) Exclusion Criteria: - children who show less than one change triggered temper outburst (temper outbursts following an unexpected change in plan, routine or expectation) per month

Additional Information

Official title PREDICTORS (Parents Resources for Decreasing the Incidence of Change Triggered Temper Outbursts)
Description The aims of PREDICTORS are: 1. To refine the tools to implement and evaluate a resource-efficient caregiver training program for signalling changes to children with intellectual disabilities or autism spectrum disorders. 2. To pilot the program to test the feasibility of taking it forward into a clinical trial. 3. To conduct a process and economic evaluation of the pilot intervention to provide further data on its suitability for a clinical trial. Parents/caregivers of children aged 7-16 years old who frequently show temper outbursts when things change in their routines or plans will keep a web-based diary accessed via smart phone or other device on their child's temper outbursts for a 6 month period (baseline). After 6 months of keeping this diary, parents/caregivers will then access web-based training for approximately 1 month which will include sessions to study once or twice per week as well as exercises to practice in between sessions. After the training is complete parents will be asked to implement the strategies they have learnt in the 6 months that follow. In addition researchers from the university will telephone parents/ caregivers to ask some questions about their child's temper outbursts and on the effects this behaviour has on daily life. Parents will be interviewed at three points during the study (before baseline, after baseline, before intervention and after intervention phases). Interviews will focus on gathering information of their child's behaviour. Focus groups with relevant experienced professionals and parents (not participating in the main part of the study) will guide the training resource development and development and content of the behaviour diary used by parents during the study.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Queen's University, Belfast.