Child BehaviorPhase 1PREDICTORSNCT02567357
Parents Resources for Decreasing the Incidence of Change Triggered Temper Outbursts
A Phase 1 study testing Visual Scheduling and signalling change in people with Child Behavior, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior
- What is being tested?
- Visual Scheduling and signalling change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged 7-16 years of age, with temper outbursts triggered by change to routine or plans and their parent(s)/caregiver(s)
Who cannot join
- children who show less than one change triggered temper outburst (temper outbursts following an unexpected change in plan, routine or expectation) per month
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's University Belfast
Belfast, Northern Ireland, BT7 1NN
About this study
Official title: PREDICTORS (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).
Read the 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.
- Conditions
- Child Behavior
- Being tested
- Visual Scheduling, signalling change
- Keywords
- change triggered temper outbursts, parent training, autism, intellectual disability, Prader-Willi syndrome, Fragile X syndrome, web-based training, Down syndrome
- Medical subject headings
- Child Behavior, Autistic Disorder, Intellectual Disability, Prader-Willi Syndrome, Fragile X Syndrome, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual SchedulingBehavioural
Also called 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.
signalling changeBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: signalling change |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
An informant report questionnaire on the cost to health services associated with the child over the previous 6 months
Measured: 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
Informant report ratings on the use of the intervention strategy and how easy this was
Measured: every three days for 7 months from after baseline onwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warwick, University of Birmingham
- Responsible party
- Principal investigator, Kate Woodcock, Queen's University, Belfast
- Investigators
- Kate Woodcock, PhD, Study director, Queen's Univerisity Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567357
- Sponsor's protocol ID
- R2149PSY
- Acronym
- PREDICTORS
- Status last verified
- Sep 2016
- First submitted
- 24 Sep 2015
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICTORS (Parents Resources for Decreasing the Incidence of Change Triggered Temper Outbursts)
- ClinicalTrials.gov ID
- NCT02567357
- Acronym / sponsor ID
- PREDICTORS / R2149PSY
- Conditions
- Child Behavior
- Keywords
- change triggered temper outbursts, parent training, autism, intellectual disability, Prader-Willi syndrome, Fragile X syndrome, web-based training, Down syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- University of Warwick, University of Birmingham
- Study start
- Jan 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
'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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual Scheduling | Active comparator | Behavioral: Visual SchedulingA 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. |
| Signalling change | Experimental | Behavioral: signalling changeA 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. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children aged 7-16 years of age, with temper outbursts triggered by change to routine or plans and their parent(s)/caregiver(s)
Key exclusion criteria (1 listed)
- children who show less than one change triggered temper outburst (temper outbursts following an unexpected change in plan, routine or expectation) per month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual SchedulingAlso: antecedent manipulationCaregivers 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. | Behavioural | Visual Scheduling |
| signalling changeAlso: cuing changeCaregivers 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. | Behavioural | Signalling change |
Primary outcome
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.
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
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Behaviour diary (primary outcome measure) can be viewed via test code 794613Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Woodcock, PhD study director
Queen's Univerisity Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Visual Scheduling and signalling change in people with Child Behavior, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of temper outbursts between baseline and intervention (time frame: 6 months baseline, 6 months during intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.