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대처 중재 구성 요소의 효과를 테스트하기 위한 요인 최적화 시도

2026년 9월 4일 업데이트: Karey O'Hara, Arizona State University

정신 건강 문제의 위험을 줄이기 위해 이혼 후 부모 간 갈등에 노출된 아동의 효과적인 대처 촉진

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

148

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Arizona
      • Tempe, Arizona, 미국, 85087
        • Arizona State University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

9년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 요인 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

실험적: 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.

실험적: 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.

실험적: 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.

실험적: 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.

실험적: 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.

실험적: 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.

실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mean Child-Reported Interparental Emotional Security Score on the SIS-SF at 3-Month Follow-Up
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Karey L O'Hara, PhD, Arizona State University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 2월 18일

기본 완료 (실제)

2026년 3월 30일

연구 완료 (실제)

2026년 3월 30일

연구 등록 날짜

최초 제출

2023년 2월 17일

QC 기준을 충족하는 최초 제출

2023년 4월 8일

처음 게시됨 (실제)

2023년 4월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 4일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • STUDY00016078
  • K01MH120321 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

one year post data collection

IPD 공유 액세스 기준

qualified researchers who have gained IRB approval and pre-registered their analyses

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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