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Completed

NCT Number: NCT02567357

Parents Resources for Decreasing the Incidence of Change Triggered Temper Outbursts

'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).

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Key information

Conditions

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

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Queen's University Belfast

Belfast, Northern Ireland, BT7 1NN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: antecedent manipulation

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.

Other names: cuing change

Primary outcomes

  1. Change in frequency of temper outbursts between baseline and intervention

    Time frame: 6 months baseline, 6 months during 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.

  2. 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

    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

Secondary outcomes

  1. 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

    An informant report questionnaire on the cost to health services associated with the child over the previous 6 months

  2. Process information on how the intervention strategies are being implemented by caregivers

    Time frame: every three days for 7 months from after baseline onwards

    Informant report ratings on the use of the intervention strategy and how easy this was

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • University of Birmingham
  • University of Warwick

Registry information

Official study title

PREDICTORS (Parents Resources for Decreasing the Incidence of Change Triggered Temper Outbursts)

Acronym: PREDICTORS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 5, 2015
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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