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Completed

NCT Number: NCT07006220

Project COPE-Spain (Coping Options for Parent Empowerment)

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.

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Key information

Conditions

Anxiety Symptoms Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Symptoms Mental Disorders Parental Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IES Isaac Newton

Madrid, 28035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

COPE Program

Behavioral

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.

Primary outcomes

  1. Measure of Anxiety as assessed by the OASIS

    Time frame: 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).

  2. Measure of Depression as assessed by the ODSIS

    Time frame: 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.

  3. Parental Stress Scale (PSS)

    Time frame: 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.

  4. Change in parenting beliefs as measured by the PSOC Scale

    Time frame: 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.

Secondary outcomes

  1. Parent-report of the Revised Children's Anxiety and Depression Scale (RCADS-30)

    Time frame: Baseline, Week 4 and up to 1 month after the program.

    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.

Other outcomes

  1. Socio-Demographic Information Questionnaire

    Time frame: Baseline.

  2. End of Program Questionnaire

    Time frame: Week 4

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Educación a Distancia

Other

Collaborators

  • IES Isaac Newton

Registry information

Official study title

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

Acronym: COPE-ES

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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