Clinical trial NCT02567357: Parents Resources for Decreasing the Incidence of Change Triggered Temper Outbursts
Official title: PREDICTORS (Parents Resources for Decreasing the Incidence of Change Triggered Temper Outbursts)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Child Behavior
Keywords: change triggered temper outbursts
parent training
autism
intellectual disability
Prader-Willi syndrome
Fragile X syndrome
web-based training
Down syndrome
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: University of Warwick
name: University of Birmingham
First posted: 2015-10-05
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in frequency of temper outbursts between baseline and intervention
timeFrame: 6 months baseline, 6 months during intervention
measure: Change in percentage of changes to routines/plans experienced by children that are followed by temper outbursts between baseline and intervention
timeFrame: 6 months baseline, 6 months during intervention
Secondary outcomes:
measure: Change in cost of services with which the child engages - Cost of Services Receipt Inventory
timeFrame: within 2 weeks before baseline, within one month after baseline, within one month following intervention
measure: Process information on how the intervention strategies are being implemented by caregivers
timeFrame: every three days for 7 months from after baseline onwards
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Queen's University Belfast
state: Northern Ireland
Study officials:
affiliation: Queen's Univerisity Belfast
name: Kate Woodcock, PhD
role: STUDY_DIRECTOR
References: