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

14. februar 2020 opdateret af: Kate Woodcock, Queen's University, Belfast

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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

80

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • Northern Ireland
      • Belfast, Northern Ireland, Det Forenede Kongerige, BT7 1NN
        • Queen's University Belfast

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

7 år til 16 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Visual Scheduling
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.
Adfærdsmæssigt: Visual Scheduling
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.
Andre navne:
  • antecedent manipulation
Eksperimentel: Signalling change
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.
Adfærdsmæssigt: signalling 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.
Andre navne:
  • cuing change

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in frequency of temper outbursts between baseline and intervention
Tidsramme: 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.
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
Tidsramme: 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
6 months baseline, 6 months during intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in cost of services with which the child engages - Cost of Services Receipt Inventory
Tidsramme: 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
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
Tidsramme: 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
every three days for 7 months from after baseline onwards

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Queen's University, Belfast

Samarbejdspartnere

University of Warwick
University of Birmingham

Efterforskere

  • Studieleder: Kate Woodcock, PhD, Queen's Univerisity Belfast

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2015

Primær færdiggørelse (Faktiske)

1. maj 2017

Studieafslutning (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først indsendt

24. september 2015

Først indsendt, der opfyldte QC-kriterier

30. september 2015

Først opslået (Skøn)

5. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. februar 2020

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • R2149PSY

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Børns adfærd

Kliniske forsøg med Visual Scheduling

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Placeringer

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