An interventional study of COPE Program in Anxiety Symptoms, Depressive Symptoms and Parental Stress, sponsored by Universidad Nacional de Educación a Distancia. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Universidad Nacional de Educación a Distancia · Not applicable, Interventional, and Prevention
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.
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 26 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Universidad Nacional de Educación a Distancia is the lead sponsor of 15 studies on the registry; none are open to participants now.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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.
Behavioral: COPE Program
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.
The COPE Program (Coping Options for Parent Empowerment) is a brief, structured, transdiagnostic intervention designed to enhance parents' emotional regulation skills, improve parenting strategies, and foster a positive family environment. The program consists of four in-person group sessions, each lasting 90 minutes, conducted over four consecutive weeks. Each session focuses on specific emotional regulation and parenting skills: Session 1: Understanding emotional responses and parenting strategies based on positive reinforcement, selective attention, and empathy. Session 2: Identifying family values, promoting healthy routines, and planning alternative parenting behaviors. Session 3: Practicing mindfulness techniques and modeling emotional regulation in the presence of children. Session 4: Addressing intolerance to uncertainty, cognitive distortions, and promoting healthy independence in adolescents.
Measure of Anxiety as assessed by the OASIS
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).
Time frame: Baseline, Week 4 and up to 1 month after the program.
Measure of Depression as assessed by the ODSIS
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.
Time frame: Baseline, Week 4 and up to 1 month after the program.
Parental Stress Scale (PSS)
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.
Time frame: Baseline, Week 4 and up to 1 month after the program.
Change in parenting beliefs as measured by the PSOC Scale
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.
Time frame: Baseline, Week 4 and up to 1 month after the program.
Parent-report of the Revised Children's Anxiety and Depression Scale (RCADS-30)
The Revised Child Anxiety and Depression Scale - Parent Version (RCADS-P). The RCADS-30-Parent version is designed to assess symptoms of anxiety and depression in children and adolescents, based on parental reports. It is an adaptation of the self-reported RCADS-30 and evaluates six anxiety and mood-related dimensions: Generalized Anxiety Disorder (GAD), Panic Disorder (PD), Social Phobia (SP), Separation Anxiety Disorder (SAD), Obsessive-Compulsive Disorder (OCD), Major Depressive Disorder (MDD). The RCADS-P consists of 30 items. Each item is rated on a 4-point Likert scale ranging from 0 (never) to 3 (always), reflecting the frequency of the child's symptoms as perceived by the parent or caregiver.
Time frame: Baseline, Week 4 and up to 1 month after the program.
Socio-Demographic Information Questionnaire
Time frame: Baseline.
End of Program Questionnaire
Time frame: Week 4
Plan to share: Undecided
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Universidad Nacional de Educación a Distancia