Anxiety SymptomsCOPE-ESNCT07006220
Project COPE-Spain (Coping Options for Parent Empowerment)
A study testing COPE Program in people with Anxiety Symptoms and Depressive Symptoms, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Symptoms, Depressive Symptoms, Parental Stress
- What is being tested?
- COPE Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 22 Apr 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COPE-Spain: Project COPE (Coping Options for Parent Empowerment) Adapted for Parents With Adolescent Children in Spain
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.
Read the 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.
- Conditions
- Anxiety Symptoms, Depressive Symptoms, Parental Stress
- Being tested
- COPE Program
- Keywords
- adolescents, transdiagnostic, school, COPE, UP-A, UP, Unified Protocol, Spain
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPE ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: Baseline, Week 4 and up to 1 month after the program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start22 Apr 2025
- Primary completion31 Jul 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Educación a Distancia
- Sponsor type
- University, hospital or other
- Collaborators
- IES Isaac Newton
- Responsible party
- Principal investigator, Julia García Escalera, Universidad Nacional de Educación a Distancia
- Investigators
- Julia Garcia-Escalera, Associate Professor, Study director, Universidad Nacional de Educación a Distancia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006220
- Sponsor's protocol ID
- COPE-ES
- Acronym
- COPE-ES
- Status last verified
- Aug 2025
- First submitted
- 20 Mar 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35976544Ehrenreich-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.
PubMed 34629841
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPE-Spain: Project COPE (Coping Options for Parent Empowerment) Adapted for Parents With Adolescent Children in Spain
- ClinicalTrials.gov ID
- NCT07006220
- Acronym / sponsor ID
- COPE-ES / COPE-ES
- Conditions
- Anxiety Symptoms, Depressive Symptoms, Parental Stress
- Keywords
- adolescents, transdiagnostic, school, COPE, UP-A, UP, Unified Protocol, Spain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidad Nacional de Educación a DistanciaUniversity, hospital or other
- Collaborators
- IES Isaac Newton
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPE Group | Experimental | Behavioral: COPE ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPE ProgramThe 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. | Behavioural | COPE Group |
Primary outcome
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).
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.
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 35976544Halliday 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.
- Background: PubMed 34629841Ehrenreich-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Garcia-Escalera, Associate Professor study director
Universidad Nacional de Educación a Distancia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPE Program in people with Anxiety Symptoms and Depressive Symptoms, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Anxiety as assessed by the OASIS (time frame: Baseline, Week 4 and up to 1 month after the program.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07006220, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.