Clinical trial NCT07006220: Project COPE-Spain (Coping Options for Parent Empowerment)
Official title: COPE-Spain: Project COPE (Coping Options for Parent Empowerment) Adapted for Parents With Adolescent Children in Spain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Symptoms
Depressive Symptoms
Parental Stress
Keywords: adolescents
transdiagnostic
school
COPE
UP-A
UP
Unified Protocol
Spain
Lead sponsor: Universidad Nacional de Educación a Distancia
Sponsor class: OTHER
Collaborators: name: IES Isaac Newton
First posted: 2025-06-05
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measure of Anxiety as assessed by the OASIS
timeFrame: Baseline, Week 4 and up to 1 month after the program.
measure: Measure of Depression as assessed by the ODSIS
timeFrame: Baseline, Week 4 and up to 1 month after the program.
measure: Parental Stress Scale (PSS)
timeFrame: Baseline, Week 4 and up to 1 month after the program.
measure: Change in parenting beliefs as measured by the PSOC Scale
timeFrame: Baseline, Week 4 and up to 1 month after the program.
Secondary outcomes:
measure: Parent-report of the Revised Children's Anxiety and Depression Scale (RCADS-30)
timeFrame: Baseline, Week 4 and up to 1 month after the program.
Other outcomes:
measure: Socio-Demographic Information Questionnaire
timeFrame: Baseline.
measure: End of Program Questionnaire
timeFrame: Week 4
Locations:
city: Madrid
country: Spain
facility: IES Isaac Newton
Study officials:
affiliation: Universidad Nacional de Educación a Distancia
name: Julia Garcia-Escalera, Associate Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.