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临床试验/NCT07006220
NCT07006220已完成不适用

COPE-Spain: Project COPE (Coping Options for Parent Empowerment) Adapted for Parents With Adolescent Children in Spain

Universidad Nacional de Educación a Distancia2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年4月22日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
2
主要终点
Measure of Anxiety as assessed by the OASIS

研究概览

简要总结

The goal of this study trial is to establish the preliminary clinical utility of the COPE program (Coping Options for Parent Empowerment) adapted for caregivers of adolescents in the Spanish context. This program aims to improve parents' emotional well-being, enhance their parenting skills, and promote positive changes in their childrens' emotional and behavioral well-being. This study will adapt the COPE program for in-person group administration in the Spanish context, specifically in the school setting.

详细描述

The research project, titled "COPE-Spain: Adapting Project COPE (Coping Options for Parent Empowerment) for Caregivers of Adolescents in the Spanish Context," aims to evaluate the preliminary clinical utility of Project COPE (Coping Options for Parent Empowerment). Project COPE was developed at the University of Miami, with Dr. Jill Ehrenreich-May as the Principal Investigator, and has been evaluated in several studies. This protocol consists of a brief, structured intervention delivered in four group sessions, designed to improve parents' emotional well-being, strengthen their emotional regulation skills, and foster a positive family environment. Initially, Project COPE was developed to help caregivers of children during the COVID-19 pandemic and was later administered to caregivers of children with Autism Spectrum Disorder (ASD). The present study seeks to adapt Project COPE to be administered to caregivers of adolescents (instead of children) as an in-person group program implemented in the school setting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being a parent or legal guardian of an adolescent enrolled at IES Isaac Newton during the 2024-2025 academic year.
  • Participants must have availability to attend all four program sessions at the scheduled time.

排除标准

  • Current Psychological Treatment: the parent or legal guardian is currently receiving individual psychological treatment and/or family therapy.
  • Psychiatric medication changes within 4 weeks prior to the study and/or psychiatric medication changes during the study.

研究组 & 干预措施

COPE Group

Experimental

Participants in this group will receive the COPE (Coping Options for Parent Empowerment) Program adapted as a universal prevention program for caregivers of adolescents. The program will consist of four in-person group sessions (90 minutes each) conducted over four consecutive weeks. The program focuses on improving parents' emotional regulation, enhancing parenting skills, and fostering a positive family environment.

Assessments will be conducted at baseline (pre-intervention), post-intervention, and at 1-month follow-up.

干预措施: COPE Program (Behavioral)

No Intervention: Waitlist Control Group

No Intervention

Participants in this group will serve as a waitlist control and will not receive the intervention immediately. Instead, they will begin the program after the experimental group has completed it, resulting in a 4-week waiting period. During this time, they will complete an additional assessment at the 4-week mark prior to their baseline, aligning with the pre-intervention timing of the experimental group. In total, they will complete assessments at four time points: 4 weeks prior to baseline, at baseline, post-intervention, and at 1-month follow-up. After the waiting period, they will receive the same COPE program intervention, following the identical structure and session format as the experimental group.

结局指标

主要结局

Measure of Anxiety as assessed by the OASIS

时间窗: Baseline, Week 4 and up to 1 month after the program.

The Overall Anxiety Severity and Impairment Scale is a 5 self-reported questionnaire evaluating the severity and functional impairment due to anxiety. The total score ranges from 0 (no anxiety) to 20 (severe anxiety).

Measure of Depression as assessed by the ODSIS

时间窗: Baseline, Week 4 and up to 1 month after the program.

Overall Depression Severity and Impairment Scale is a 5-item measure assessing the frequency and intensity of depressive symptoms. The total score ranges from 0-20 with the higher score indicating increased depression.

Parental Stress Scale (PSS)

时间窗: Baseline, Week 4 and up to 1 month after the program.

The Parental Stress Scale is an 18-item measure assessing parents' feelings about their parenting role, exploring both positive (e.g., emotional benefits, personal development) and negative (e.g., demands on resources, feelings of stress) aspects on parenthood. All items are rated on 5-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree). Items are summed with higher scores indicating higher levels of parental stress.

Change in parenting beliefs as measured by the PSOC Scale

时间窗: Baseline, Week 4 and up to 1 month after the program.

Parenting Sense of Competence scale is a 17-item measure of parenting self-efficacyand satisfaction. It has a total score ranging from 17 to 102 with the higher scores indicating greater self-efficacy and satisfaction in the parenting role.

次要结局

  • Parent-report of the Revised Children's Anxiety and Depression Scale (RCADS-30)(Baseline, Week 4 and up to 1 month after the program.)

研究者

发起方
Universidad Nacional de Educación a Distancia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julia García Escalera

Associate Professor

Universidad Nacional de Educación a Distancia

研究点 (2)

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