Parents Resources for Decreasing the Incidence of Change Triggered Temper Outbursts (PREDICTORS)
PREDICTORS (Parents Resources for Decreasing the Incidence of Change Triggered Temper Outbursts)
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究場所
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Northern Ireland
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Belfast、Northern Ireland、イギリス、BT7 1NN
- Queen's University Belfast
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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.
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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.
他の名前：
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実験的：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.
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in frequency of temper outbursts between baseline and intervention
時間枠：6 months baseline, 6 months during intervention
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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
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Change in percentage of changes to routines/plans experienced by children that are followed by temper outbursts between baseline and intervention
時間枠：6 months baseline, 6 months during intervention
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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
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6 months baseline, 6 months during intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in cost of services with which the child engages - Cost of Services Receipt Inventory
時間枠：within 2 weeks before baseline, within one month after baseline, within one month following intervention
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An informant report questionnaire on the cost to health services associated with the child over the previous 6 months
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within 2 weeks before baseline, within one month after baseline, within one month following intervention
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Process information on how the intervention strategies are being implemented by caregivers
時間枠：every three days for 7 months from after baseline onwards
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Informant report ratings on the use of the intervention strategy and how easy this was
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every three days for 7 months from after baseline onwards
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協力者と研究者
捜査官
- スタディディレクター：Kate Woodcock, PhD、Queen's Univerisity Belfast
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- R2149PSY
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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