Parents Resources for Decreasing the Incidence of Change Triggered Temper Outbursts

NCT02567357 | Completed Phase 1

• 1 other identifier: R2149PSY
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

'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).

Conditions

Child Behavior

Keywords

change triggered temper outbursts; parent training; autism; intellectual disability; Prader-Willi syndrome; Fragile X syndrome; web-based training; Down syndrome

Outcome Measures

Primary Outcomes (2)

• Change in frequency of temper outbursts between baseline and intervention

  Informant reports of outbursts using a web-based behaviour diary after they occur. Entries comprise check lists of individual behaviours comprised in the outburst, an intensity rating (1-3 or 1-5 point scale depending on the different intensities of outburst parents were able to operationally describe), a description of the duration (\<1 minute; \>1 \& \<5 minutes; \>5 \& \<15 minutes; \>15 minutes \& \< 1 hour; \>1 hour \[specify\]); a check list of possible antecedent events; and a check list of possible actions taken by caregivers. Frequency per month of temper outbursts following change-related antecedents of each intensity level and each duration will comprise the primary measurement. Reports will also be made every 3 days, of the number of outbursts over the previous 3 days (for validity checking); and of the number of changes to routines/plans experienced by the child. The percentage of changes that were followed by outbursts will comprise measurement 2.

  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

  Informant reports will be made using a scheduled entry section of the behaviour diary, on the number of changes to routines /plans experienced by the child since the previous entry. These data will be used to calculate the percentage of experienced changes that were followed by a temper outburst

  6 months baseline, 6 months during intervention

Secondary Outcomes (2)

• Change in cost of services with which the child engages - Cost of Services Receipt Inventory

  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

  every three days for 7 months from after baseline onwards

Study Arms (2)

Visual Scheduling

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.

Behavioral: Visual Scheduling

Signalling change

EXPERIMENTAL

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.

Behavioral: signalling change

Interventions

Visual Scheduling BEHAVIORAL

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.

Also known as: antecedent manipulation

Visual Scheduling

signalling change BEHAVIORAL

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.

Also known as: cuing change

Signalling change

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children aged 7-16 years of age, with temper outbursts triggered by change to routine or plans and their parent(s)/caregiver(s)

You may not qualify if:

• children who show less than one change triggered temper outburst (temper outbursts following an unexpected change in plan, routine or expectation) per month

Sponsors & Collaborators

• Queen's University, Belfast: lead
• University of Warwick: collaborator
• University of Birmingham: collaborator

Study Sites (1)

Queen's University Belfast

Belfast, Northern Ireland, BT7 1NN, United Kingdom

Location

Related Links

• Behaviour diary (primary outcome measure) can be viewed via test code 794613

MeSH Terms

Conditions

Child Behavior; Autistic Disorder; Intellectual Disability; Prader-Willi Syndrome; Fragile X Syndrome; Down Syndrome

Condition Hierarchy (Ancestors)

Behavior; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; X-Linked Intellectual Disability; Sex Chromosome Disorders; Genetic Diseases, X-Linked; Heredodegenerative Disorders, Nervous System

Study Officials

• Kate Woodcock, PhD

  Queen's Univerisity Belfast

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: October 5, 2015
• Study Start: January 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 17, 2020

Record last verified: 2016-09

Locations

GB (1)