対処介入コンポーネントの効果をテストするための要因最適化試行
精神的健康問題のリスクを軽減するために、離婚後の親子間の対立にさらされた子供たちによる効果的な対処の促進
This study will identify components for inclusion in a coping intervention package to reduce mental health problems among children exposed to high interparental conflict after parental separation/divorce. Reappraisal, distraction, and relaxation coping strategies are related to fewer mental health problems among children, making intervention components based on these strategies key candidates for inclusion in an optimized coping intervention. The primary aim is to experimentally assess the main and interactive effects of three digital intervention coping components (reappraisal, distraction, relaxation) on children's coping efficacy, emotional security, and internalizing and externalizing problems. Secondary aims are to assess indirect effects of the intervention components on children's coping efficacy, emotional security, and internalizing and externalizing problems through their cognitive, emotional, and behavioral reactions to post-separation/divorce interparental conflict events.
調査の概要
状態
詳細な説明
A randomized and counterbalanced 2x2x2 factorial trial (N = 144 children, ages 9-12) will be conducted to assess the individual effects of the three digital coping intervention components. The three components to be tested will be: (1) Reappraisal (No vs. Yes), (2) Distraction (No vs. Yes), (3) Relaxation (No vs. Yes). Components that meet a priori thresholds for meaningful change will be combined to form an intervention package that will be evaluated in a subsequent randomized controlled trial.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Arizona
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Tempe、Arizona、アメリカ、85087
- Arizona State University
-
-
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:
- child between ages 9-12 whose parents are separated or divorced
- child and one parent are fluent in English
- a parent with sufficient contact (i.e., at least 4 overnights and/or 12 daytime visits per month) with child who is willing to complete study assessments and has legal right to give permission for the child to participate in research
- child-report of high exposure to IPC (mean Z score ≥ 40th percentile on the two child report measures of IPC; score standardization based on data from 559 youth whose parents participated in an experimental parenting program)
- elevated internalizing or externalizing problems (T score in the borderline clinical range according to either child or parent report on the BPM).
Exclusion Criteria:
- in active therapy
- score ≥ 99th percentile on either internalizing and externalizing problems subscale
- endorse suicidality (will be ineligible for the study and referred for treatment)
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：防止
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Education
Participants will complete an educational digital module and no skills-based digital modules. |
This is a constant component; all participants will get a psychoeducation digital module. |
|
実験的：Education + Reappraisal
Participants will complete an educational digital module and a skills-based digital module that teaches reappraisal coping. |
This is a constant component; all participants will get a psychoeducation digital module. This digital module will teach reappraisal coping skills. |
|
実験的：Education + Distraction
Participants will complete an educational digital module and a skills-based digital module that teaches distraction coping. |
This is a constant component; all participants will get a psychoeducation digital module. This digital module will teach distraction coping skills. |
|
実験的：Education + Relaxation
Participants will complete an educational digital module and a skills-based digital module that teaches relaxation coping. |
This is a constant component; all participants will get a psychoeducation digital module. This digital module will teach relaxation coping skills. |
|
実験的：Education + Reappraisal + Distraction
Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches distraction coping. |
This is a constant component; all participants will get a psychoeducation digital module. This digital module will teach reappraisal coping skills. This digital module will teach distraction coping skills. |
|
実験的：Education + Reappraisal + Relaxation
Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches relaxation coping. |
This is a constant component; all participants will get a psychoeducation digital module. This digital module will teach reappraisal coping skills. This digital module will teach relaxation coping skills. |
|
実験的：Education + Distraction + Relaxation
Participants will complete an educational digital module and two skills-based digital modules, one that teaches distraction coping and one that teaches relaxation coping. |
This is a constant component; all participants will get a psychoeducation digital module. This digital module will teach distraction coping skills. This digital module will teach relaxation coping skills. |
|
実験的：Education + Reappraisal + Distraction + Relaxation
Participants will complete an educational digital module and three skills-based digital modules, one that teaches reappraisal coping, one that teaches distraction coping, and one that teaches relaxation coping. |
This is a constant component; all participants will get a psychoeducation digital module. This digital module will teach reappraisal coping skills. This digital module will teach distraction coping skills. This digital module will teach relaxation coping skills. |
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 |
|---|---|---|
|
Mean Child-Reported Interparental Emotional Security Score on the SIS-SF at 3-Month Follow-Up
時間枠：approximately 3 months after posttest
|
Child-reported Security in the Interparental Subsystem Scale-Short Form (SIS-SF; Holt et al., 2020). The score is the mean of 17 items rated from 0 (not at all true) to 3 (very true for me). Higher scores indicate greater interparental emotional security (better outcome). The outcome table reports observed scores; factorial analyses adjust for baseline SIS-SF and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Child-Reported Family Emotional Security Score on the SIFS at 3-Month Follow-Up
時間枠：approximately 3 months after posttest
|
Child-reported Security in the Family System Scale (SIFS; Forman & Davies, 2005). The score is the mean of 24 items rated from 0 (completely disagree) to 3 (completely agree). Higher scores indicate greater family emotional security (better outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline SIFS score and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Child-Reported Coping Efficacy Score on the CES at 3-Month Follow-Up
時間枠：approximately 3 months after posttest
|
Child-reported Coping Efficacy Scale (CES; Sandler et al., 2000). The score is the mean of 7 items rated from 0 (not at all) to 3 (very). Higher scores indicate greater coping efficacy (better outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline CES score and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Child-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up
時間枠：approximately 3 months after posttest
|
Child-reported Brief Problem Monitor (BPM) Internalizing Problems scale. The score is the mean of 6 items rated from 0 (not true) to 2 (very true). Higher scores indicate more internalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline child-reported BPM Internalizing Problems score and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Parent-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up
時間枠：approximately 3 months after posttest
|
Parent-reported Brief Problem Monitor (BPM) Internalizing Problems scale. The score is the mean of 6 items rated from 0 (not true) to 2 (very true). Higher scores indicate more internalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline parent-reported BPM Internalizing Problems score and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Child-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up
時間枠：approximately 3 months after posttest
|
Child-reported Brief Problem Monitor (BPM) Externalizing Problems scale. The score is the mean of 7 items rated from 0 (not true) to 2 (very true). Higher scores indicate more externalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline child-reported BPM Externalizing Problems score and prespecified covariates. |
approximately 3 months after posttest
|
|
Mean Parent-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up
時間枠：approximately 3 months after posttest
|
Parent-reported Brief Problem Monitor (BPM) Externalizing Problems scale. The score is the mean of 7 items rated from 0 (not true) to 2 (very true). Higher scores indicate more externalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline parent-reported BPM Externalizing Problems score and prespecified covariates. |
approximately 3 months after posttest
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Karey L O'Hara, PhD、Arizona State University
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 (実際)
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
キーワード
その他の研究ID番号
- STUDY00016078
- K01MH120321 (米国 NIH グラント/契約)
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?
IPD プランの説明
Study results will be shared through presentations at conferences and submissions in peer-reviewed journals. In addition, after taking all steps necessary to minimize possible re-identification of confidential data, I will make data, codebooks, and analysis scripts available to appropriate parties to verify findings and conclusions.
IPD 共有時間枠
one year post data collection
IPD 共有アクセス基準
qualified researchers who have gained IRB approval and pre-registered their analyses
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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