Project COPE-Spain (Coping Options for Parent Empowerment)

NCT07006220 | Completed

• 1 other identifier: COPE-ES
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Symptoms; Depressive Symptoms; Parental Stress

Keywords

adolescents; transdiagnostic; school; COPE; UP-A; UP; Unified Protocol; Spain

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

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

Secondary Outcomes (1)

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

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

Other Outcomes (2)

• Socio-Demographic Information Questionnaire

  Baseline.

• End of Program Questionnaire

  Week 4

Study Arms (2)

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.

Behavioral: COPE Program

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.

Interventions

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.

COPE Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional de Educación a Distancia: lead
• IES Isaac Newton: collaborator

Study Sites (1)

IES Isaac Newton

Madrid, Madrid, 28035, Spain

Location

Related Publications (2)

• Halliday ER, Cepeda SL, Grassie HL, Jensen-Doss A, Ehrenreich-May J. Initial Effects of a Brief Transdiagnostic Intervention on Parent Emotion Management During COVID-19. Child Psychiatry Hum Dev. 2024 Apr;55(2):372-383. doi: 10.1007/s10578-022-01409-5. Epub 2022 Aug 17.

  PMID: 35976544 BACKGROUND

• Ehrenreich-May J, Halliday ER, Karlovich AR, Gruen RL, Pino AC, Tonarely NA. Brief Transdiagnostic Intervention for Parents With Emotional Disorder Symptoms During the COVID-19 Pandemic: A Case Example. Cogn Behav Pract. 2021 Nov;28(4):690-700. doi: 10.1016/j.cbpra.2021.01.002. Epub 2021 Feb 20.

  PMID: 34629841 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Julia Garcia-Escalera, Associate Professor

  Universidad Nacional de Educación a Distancia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: June 5, 2025
• Study Start: April 22, 2025
• Primary Completion: July 31, 2025
• Study Completion: December 1, 2025
• Last Updated: April 29, 2026

Record last verified: 2025-08

Locations

ES (1)