跳至主要内容
临床试验/NCT05822687
NCT05822687已完成不适用

Promoting Effective Coping by Children Exposed to Post-divorce Interparental Conflict to Reduce Risk for Mental Health Problems

Arizona State University1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2023年2月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
148
试验地点
1
主要终点
interparental emotional security

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
9 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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).

排除标准

  • •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)

研究组 & 干预措施

Education + Reappraisal

Experimental

Participants will complete an educational digital module and a skills-based digital module that teaches reappraisal coping.

干预措施: Reappraisal Coping (Behavioral)

Education + Distraction

Experimental

Participants will complete an educational digital module and a skills-based digital module that teaches distraction coping.

干预措施: Education (Behavioral)

Education + Distraction

Experimental

Participants will complete an educational digital module and a skills-based digital module that teaches distraction coping.

干预措施: Distraction Coping (Behavioral)

Education + Relaxation

Experimental

Participants will complete an educational digital module and a skills-based digital module that teaches relaxation coping.

干预措施: Education (Behavioral)

Education + Relaxation

Experimental

Participants will complete an educational digital module and a skills-based digital module that teaches relaxation coping.

干预措施: Relaxation Coping (Behavioral)

Education + Reappraisal + Relaxation

Experimental

Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches relaxation coping.

干预措施: Education (Behavioral)

Education + Reappraisal + Relaxation

Experimental

Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches relaxation coping.

干预措施: Reappraisal Coping (Behavioral)

Education + Reappraisal + Relaxation

Experimental

Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches relaxation coping.

干预措施: Relaxation Coping (Behavioral)

Education + Distraction + Relaxation

Experimental

Participants will complete an educational digital module and two skills-based digital modules, one that teaches distraction coping and one that teaches relaxation coping.

干预措施: Distraction Coping (Behavioral)

Education + Distraction + Relaxation

Experimental

Participants will complete an educational digital module and two skills-based digital modules, one that teaches distraction coping and one that teaches relaxation coping.

干预措施: Relaxation Coping (Behavioral)

Education + Reappraisal + Distraction + Relaxation

Experimental

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.

干预措施: Education (Behavioral)

Education + Reappraisal + Distraction + Relaxation

Experimental

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.

干预措施: Reappraisal Coping (Behavioral)

Education + Reappraisal + Distraction + Relaxation

Experimental

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.

干预措施: Distraction Coping (Behavioral)

Education

Experimental

Participants will complete an educational digital module and no skills-based digital modules.

干预措施: Education (Behavioral)

Education + Reappraisal

Experimental

Participants will complete an educational digital module and a skills-based digital module that teaches reappraisal coping.

干预措施: Education (Behavioral)

Education + Reappraisal + Distraction

Experimental

Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches distraction coping.

干预措施: Reappraisal Coping (Behavioral)

Education + Reappraisal + Distraction

Experimental

Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches distraction coping.

干预措施: Distraction Coping (Behavioral)

Education + Reappraisal + Distraction

Experimental

Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches distraction coping.

干预措施: Education (Behavioral)

Education + Reappraisal + Distraction + Relaxation

Experimental

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.

干预措施: Relaxation Coping (Behavioral)

Education + Distraction + Relaxation

Experimental

Participants will complete an educational digital module and two skills-based digital modules, one that teaches distraction coping and one that teaches relaxation coping.

干预措施: Education (Behavioral)

结局指标

主要结局

interparental emotional security

时间窗: pretest at study entry

Security in the Interparental Subsystem Scale - Short Form (SIS-SF; Holt et al., 2020) 17 items rated on 4 point scale (0 = not at all true, 3 = very true for me) higher scores indicate better outcome

family emotional security

时间窗: pretest at study entry

Security in the Family System Scale (SIFS; Forman \& Davies, 2005) 24 items rated on 4 point scale (0 = completely disagree, 3 = completely agree). higher scores indicate better outcome

interparental emotional security

时间窗: posttest at one month after completion of the last assigned intervention module

Security in the Interparental Subsystem Scale - Short Form (SIS-SF; Holt et al., 2020) 17 items rated on 4 point scale (0 = not at all true, 3 = very true for me) higher scores indicate better outcome

family emotional security

时间窗: posttest at one month after completion of the last assigned intervention module

Security in the Family System Scale (SIFS; Forman \& Davies, 2005) 24 items rated on 4 point scale (0 = completely disagree, 3 = completely agree). higher scores indicate better outcome

coping efficacy

时间窗: pretest at study entry

Coping Efficacy Scale (CES; Sandler et al., 2000) 7 items rated on 4 point scale (0 = not at all, 3 = very) higher scores indicate better outcome

coping efficacy

时间窗: posttest at one month after completion of the last assigned intervention module

Coping Efficacy Scale (CES; Sandler et al., 2000) 7 items rated on 4 point scale (0 = not at all, 3 = very) higher scores indicate better outcome

internalizing problems

时间窗: pretest at study entry

Brief Problem Monitor (BPM; parent and child report) 6 items rated on a 3 point scale (0= not true, 2 = very true) higher scores indicate worse outcome

internalizing problems

时间窗: posttest at one month after completion of the last assigned intervention module

Brief Problem Monitor (BPM; parent and child report) 6 items rated on a 3 point scale (0= not true, 2 = very true) higher scores indicate worse outcome

externalizing problems

时间窗: pretest at study entry

Brief Problem Monitor (BPM; parent and child report) 7 items rated on a 3 point scale (0= not true, 2 = very true) higher scores indicate worse outcome

externalizing problems

时间窗: posttest at one month after completion of the last assigned intervention module

Brief Problem Monitor (BPM; parent and child report) 7 items rated on a 3 point scale (0= not true, 2 = very true) higher scores indicate worse outcome

interparental emotional security

时间窗: follow-up at 3 months after completion of the last assigned intervention module

Security in the Interparental Subsystem Scale - Short Form (SIS-SF; Holt et al., 2020) 17 items rated on 4 point scale (0 = not at all true, 3 = very true for me) higher scores indicate better outcome

family emotional security

时间窗: follow-up at 3 months after completion of the last assigned intervention module

Security in the Family System Scale (SIFS; Forman \& Davies, 2005) 24 items rated on 4 point scale (0 = completely disagree, 3 = completely agree). higher scores indicate better outcome

coping efficacy

时间窗: follow-up at 3 months after completion of the last assigned intervention module

Coping Efficacy Scale (CES; Sandler et al., 2000) 7 items rated on 4 point scale (0 = not at all, 3 = very) higher scores indicate better outcome

externalizing problems

时间窗: follow-up at 3 months after completion of the last assigned intervention module

Brief Problem Monitor (BPM; parent and child report) 7 items rated on a 3 point scale (0= not true, 2 = very true) higher scores indicate worse outcome

internalizing problems

时间窗: follow-up at 3 months after completion of the last assigned intervention module

Brief Problem Monitor (BPM; parent and child report) 6 items rated on a 3 point scale (0= not true, 2 = very true) higher scores indicate worse outcome

次要结局

  • Emotional distress(daily (6 weeks))
  • Cognitive appraisals - conflict specific(daily (6 weeks))
  • Cognitive appraisals - general(daily (6 weeks))
  • Physiological arousal(daily (6 weeks))
  • Coping behaviors - conflict specific(daily (6 weeks))
  • Coping behaviors - general(daily (6 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karey O'Hara

Assistant Professor

Arizona State University

研究点 (1)

Loading locations...

相似试验