Anxiety DisordersNCT05747131
Emotion Detectives In-Out: Feasibility and Efficacy of a Blended Version of the Unified Protocol for Children
A study testing Emotion Detectives In-Out and Coping Cat in people with Anxiety Disorders, run by University of Coimbra at 2 sites in Portugal.
Trial summary
The goal of this clinical trial is to test the efficacy of a blended format (i.e., a combination of face-to-face and online sessions into one integrated treatment protocol) of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in a sample of children aged between 7 and 12… Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Emotion Detectives In-Out and Coping Cat
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesPortugal
- Study dates
- Sep 2023to Dec 2024
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child is aged between 7 and 12 years;
- The child has a primary diagnosis of an anxiety disorder or clinically significant anxiety symptoms;
- Both the child and the parent are able to speak, read and understand Portuguese;
- Both the child and the parent have Internet access.
Who cannot join
- Diagnosis of a psychotic disorder, bipolar disorder, intellectual disability or autism spectrum disorder;
- Severe current suicidal ideation;
- The child is not on a stable dose of a psychotropic or other type of medication for at least 1 month prior to T0 assessment;
- The child has previously received CBT with exposure techniques.
Trial locations and contacts
2 sites in 1 country.
Ana Isabel Pereira, PhD contact
Portugal2 sites
Faculty of Psychology and Educational Sciences
Coimbra, 3000-115
Faculty of Psychology, University of Lisbon
Lisbon
Ana Isabel Pereira, PhD
Ana Isabel Pereira, PhD
About this study
Official title: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children: A Multicenter Study to Assess the Acceptability, Feasibility and Efficacy of a Blended Format of the Program in Portugal
The goal of this clinical trial is to test the efficacy of a blended format (i.e., a combination of face-to-face and online sessions into one integrated treatment protocol) of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in a sample of children aged between 7 and 12 years with a primary diagnosis of an anxiety disorder or with clinically significant levels of anxiety.
The main questions it aims to answer are:
Read more
- Is the proposed intervention (named Emotion Detectives In-Out) feasible and acceptable among Portuguese children with anxiety disorders and their parents?
- Is the Emotion Detectives In-Out intervention as effective as an evidence-based intervention for children's anxiety disorders in reducing anxiety symptomatology and changing secondary outcomes?
- What are the key predictors of adherence to the Emotion Detectives In-Out intervention?
- What are the key predictors of treatment outcomes?
Participants (children and one parent/legal representative) will:
- Participate in an initial interview with a clinical psychologist, who will assess if children and parents meet eligibility criteria.
- Complete an assessment protocol before, during, and after the intervention, as well as three months later.
- Be randomly assigned to one of the two conditions: experimental (Emotion Detectives In-Out) or active control (Coping Cat).
- Participate in one of the two psychological interventions. Researchers will compare the experimental and control groups to see if the Emotion Detectives In-Out intervention is equally efficacious as the Coping Cat intervention.
Read the detailed description
Childhood emotional disorders, particularly anxiety disorders, are an important public health concern due to their high and increasing prevalence, impact on children's functioning in multiple domains (e.g., family, academic, social), and long-term consequences. However, there is a significant gap between their needs and access to mental healthcare, with most children lacking access to evidence-based treatments (EBT). Several factors can contribute to a lack of adequate mental health care for children, including an insufficient number of trained clinicians, the difficulty of effectively disseminating the multitude of disorder-specific EBTs for emotional disorders to clinicians, and other barriers to face-to-face treatment. An Internet-based intervention can be an effective solution to overcome these difficulties. This project aims to develop and test the efficacy of a blended intervention of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C).
The UP-C is a cognitive-behavioral therapy (CBT) that takes a transdiagnostic approach to treating multiple emotional disorders simultaneously by addressing shared mechanisms underlying these disorders and employing a common set of EBT strategies (e.g., exposure, mindfulness). It is a child-friendly extension of the adult UP that delivers the UP core components in an interactive and child-friendly group format with extensive parent involvement. It has 15 weekly sessions for children and 15 weekly sessions for parents with an approximate duration of 90 minutes each. With a blended approach the researchers aim to improve the delivery of UP-C, by retaining the benefits of face-to-face and online therapy, while mitigating their limitations. This new version is expected to reduce costs of the therapy for families and institutions while also increasing compliance, motivation, uptake of treatment principles, and facilitating generalization of the application of core treatment components.
The blended version of the UP-C, named "Emotion Detectives In-Out" consists of 15 weekly sessions with the children (9 face-to-face group sessions, 4 online self-guided sessions and 2 videoconference sessions). The groups will consist of about 5 to 7 children. Face-to-face sessions have an expected duration of 90 minutes and will be implemented by clinical psychologists with specific training in the program. The online sessions were developed by the research team and are completely self-guided. These sessions last approximately 45 minutes. Parents will be asked to participate in 2 face-to-face sessions, 4 videoconference sessions and 10 self-guided online sessions.
- Conditions
- Anxiety Disorders
- Being tested
- Emotion Detectives In-Out, Coping Cat
- Keywords
- Unified Protocol, Children, Blended therapy, Parents
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Detectives In-OutBehavioural
Emotion Detectives In-Out is a blended cognitive-behavioral intervention for children with emotional disorders aged between 7 to 12 years and their parents. It contains group sessions, online self-guided sessions and videoconference sessions. The groups will consist of about 5 to 7 children. Face-to-face sessions have an expected duration of 90 minutes and will be implemented by clinical psychologists with specific training in the program. The online sessions were developed by the research team and are completely self-guided. These sessions last approximately 45 minutes. Parents will be asked to participate in 2 face-to-face sessions, 4 videoconference sessions and 10 self-guided online sessions. It is a transdiagnostic and emotion-focused manualized cognitive-behavioral therapy designed to help children reduce the intensity and frequency of strong and aversive emotional experiences and to help parents reduce parental emotional behaviors.
Coping CatBehavioural
Coping Cat is a cognitive behavioral therapy for children with anxiety aged between 7 to 13 years. Coping Cat consists of 16 weekly group sessions with the children (5 to 7 children per group) and 2 sessions with the parents. Face-to-face sessions have an expected duration of 90 minutes and will be implemented by clinical psychologists.
| Study group | Role | What they receive |
|---|---|---|
| Emotion Detectives In-Out | Experimental | Emotion Detectives In-Out consists of 15 weekly sessions with the children (9 face-to-face group sessions, 4 online sessions and 2 videoconference sessions). Receives: Behavioral: Emotion Detectives In-Out |
| Coping Cat | Active comparator | Coping Cat consists of 16 weekly group sessions with the children (5 to 7 children per group) and 2 sessions with the parents. Receives: Behavioral: Coping Cat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety symptoms as measured by the Revised Children's Anxiety and Depression Scale (RCADS).
The Revised Children's Anxiety and Depression Scale is a 47 item self-report questionnaire that measures symptoms of depression and anxiety in children and adolescents aged 8 - 18. It has 6 subscales: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). It yields a Total Anxiety Scale (the sum of the 5 anxiety subscales) and a Total Anxiety \& Depression Scale (sum of all 6 subscales). The Total Anxiety Scale ranges from 0 to 111, and the Total Anxiety \& Depression scale ranges from 0 to 141, with higher scores indicating increased symptom severity.
Measured: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up]
Change in anxiety symptoms as measured by the Revised Children's Anxiety and Depression Scale - Parent version (RCADS-P).
The Revised Child Anxiety and Depression Scale - Parent Version (RCADS-P) is a 47 item parent-reported questionnaire that measures symptoms of depression and anxiety in children and adolescents aged 8 - 18. It has 6 subscales: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). It yields a Total Anxiety Scale (the sum of the 5 anxiety subscales) and a Total Anxiety \& Depression Scale (sum of all 6 subscales). The Total Anxiety Scale ranges from 0 to 111, and the Total Anxiety \& Depression scale ranges from 0 to 141, with higher scores indicating increased symptom severity.
Measured: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in anxiety symptoms as measured by the Clinician Global Impression - Improvement scale (CGC-I).
Higher scores indicate increased symptom worsening.
Measured: within 1 week post-treatment
Change in severity of anxiety symptoms as measured by the Clinician Global Impression - Severity scale (CGC-S).
The Clinician Global Impression - Severity scale is a one-item measure assessing the clinician's perception of the severity of the patient's symptoms, with scores ranging from 1 (not at all ill) to 7 (extremely ill). Higher scores indicate increased symptom severity.
Measured: Baseline, within 1 week post-treatment
Secondary outcomes (15)
Change in the interference of anxiety in child's life, as measured by the Child Anxiety Life Interference Scale - Self-Report (CALIS-C)
The Child Anxiety Life Interference Scale - Self-Report consists of a 9-item scale administered to children. Items are rated on a 5-point Likert scale (0 = not at all to 4 = a great deal). The total score ranges from 0 to 36, with higher scores indicating greater interference of anxiety symptoms in children's life.
Measured: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in the interference of anxiety in child's life, as measured by the Child Anxiety Life Interference Scale - Parent's Report (CALIS-P)
The Child Anxiety Life Interference Scale - Parent's Report consists of two 9-item scales (Child Interference Subscale and Family Interference Subscale) administered to parents. Items are rated on a 5-point Likert scale (0 = not at all to 4 = a great deal). The total scores of the Child Interference Subscale and of the Family Interference Subscale range from 0 to 36, with higher scores indicating greater interference of anxiety symptoms in the lives of children and families, respectively.
Measured: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in children's behavioral avoidance, as measured by the Child Avoidance Measure Self-Report (CAMS)
The Child Avoidance Measure Self-Report is an 8-item self-report measure that assesses children's behavioral avoidance when faced with stimuli that elicit anxiety, fear, or worry, from the child's perspective. Items are rated on a 4-point Likert scale (0 = Almost Never to 3 = Almost Always). The total score ranges from 0 to 24, with higher scores indicating higher behavioral avoidance.
Measured: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in children's behavioral avoidance, as measured by the Child Avoidance Measure Parent-Report (CAMP)
The Child Avoidance Measure Parent-Report is an 8-item measure that assesses children's behavioral avoidance when faced with stimuli that elicit anxiety, fear, or worry, from the parents' perspective. Items are rated on a 4-point Likert scale (0 = Never, almost never, or not an issue to 3 = Almost Always). The total score ranges from 0 to 24, with higher scores indicating higher behavioral avoidance.
Measured: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in children's positive and negative affect, as measured by the Positive and Negative Affect Schedule for Children - Short Version (PANAS-C-SF)
The Positive and Negative Affect Schedule for Children - Short Version has 10 items and is composed by two subscales (Positive Affect and Negative Affect). Items are answered in a 5-item Likert scale that ranges from 1 (Very slightly or not at all) to 5 (Extremely). Both subscales can range from 5 to 25, with higher scores on Positive Affect indicating greater intensity of positive emotions, and higher scores on Negative Affect indicating greater intensity of negative emotions.
Measured: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in children's anxiety sensitivity, as measured by the Children's Anxiety Sensitivity Inventory-Revised (CASI-R).
The Children's Anxiety Sensitivity Inventory-Revised is a 31 item self-report scale that measures children's anxiety sensitivity across four domains: fear of cardiovascular symptoms, fear of publicly observable anxiety reactions, fear of cognitive dyscontrol and fear of respiratory symptoms. Items are answered in a 3-item Likert scale that ranges from 0 (Not true) to 3 (Very true). A total anxiety sensitivity score can be obtained by summing across all items and ranges from 0 to 93, with higher scores indicating higher anxiety sensitivity.
Measured: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in children's difficulties in emotion expression, as measured by the Emotional Expression Scale for Children (EESC)
The Emotional Expression Scale for Children is a 16 item self-report questionnaire that assesses children's difficulties in emotion expression (i.e., poor emotion awareness and reluctance to express emotions). Items are answered on a 5-point Likert-type scale that ranges from 1 (Not at All True) to 5 (Extremely true). The total score ranges from 16 to 80, with higher scores indicating greater difficulty in expressing emotions.
Measured: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in children's negative cognitive errors, as measured by the Children's Negative Cognitive Error Questionnaire (CNCEQ)
The Children's Negative Cognitive Error Questionnaire is a 24 item self-report questionnaire that assesses four types of cognitive errors: catastrophizing, overgeneralizing, personalizing, and selective abstraction. Items are answered on a 5-point scale that ranges from 1 (Nothing like I would think) to 5 (Exactly what I would think). A total cognitive distortion score can be obtained, ranging from 24 to 120. Higher scores indicate more distorted cognitive processes.
Measured: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in children's quality of life, as measured by the KIDSCREEN-10 Index (Parent Report)
The KIDSCREEN-10 Index (parent report) assesses children's overall levels of quality of life (physical, mental and social) as reported by their parents. Items are answered on a 5-point Likert scale ranging from 1 (never/not at all) to 5 (always/extremely). The sum of all items provides a global index of quality of life. The standardized scores ranges from 0 to 100, with higher results suggesting a better quality of life.
Measured: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in parental overprotection, as measured by the Parental Anxiety and Overprotection Scale (PAOS)
The Parental Anxiety and Overprotection Scale assesses parents' overprotection behaviors and other behaviors that aim to encourage children to cope with and face situations that cause them anxiety. The parental overprotection subscale has 7 items and the support of children's coping behaviors subscale has 3 items, which are both rated on a 5-point Likert scale ranging from 0 (nothing) to 4 (a lot). The total score of the overprotection subscale can range from 0 to 28 and total score of the support of children's coping behaviors subscale can range from 0 to 12, with higher scores indicating higher levels of parental overprotection and higher levels of parental supportive behaviors, respectively.
Measured: Baseline, within 1 week post-treatment, 3 months follow-up
Change in parental criticism as measured by the Egna Minnen Beträffande Uppfostran Scale (EMBU-P)
The Rejection subscale of Egna Minnen Beträffande Uppfostran Scale assesses parents' levels of criticism towards their child. This subscale has 17 items answered on a 4-point Likert scale that ranges from 1 (No, never) to 4 (Yes, always). The total rejection score can range from 17 to 68, with higher scores suggesting higher levels of rejection and criticism.
Measured: Baseline, within 1 week post-treatment, 3 months follow-up
Change in parental modeling of intense emotions, as measured by the Parent Emotion Regulation Scale (PERS)
The Parents' Lack of Emotional Control subscale of the Parent Emotion Regulation Scale assesses parents' lack of ability to modulate their own negative emotions in the presence of the child. This subscale has 4 items answered on a 5-point Likert scale that ranges from 0 (never or almost never) to 4 (always or almost always). The total score can range from 0 to 4, with higher scores indicating a higher level of negative emotion modeling.
Measured: Baseline, within 1 week post-treatment, 3 months follow-up
Change in parental inconsistency, as measured by the Parenting Inconsistency Scale
Parenting Inconsistency Scale has 9 items answered on a 5-point Likert scale that ranges from 1 (does not describes me at all) to 5 (describes me completely). The total score can range from 1 to 5, with higher scores indicating a higher level of parental inconsistency.
Measured: Baseline, within 1 week post-treatment, 3 months follow-up
Change in parental depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9).
The Patient Health Questionnaire-9 is a brief self-report measure used to monitor the severity of depression symptoms. The scale has 9 items answered on a 4-point Likert scale that ranges from 0 (not at all) to 3 (nearly every day). The total score can range from 0 to 27, with higher scores indicating higher levels of depression severity.
Measured: Baseline, within 1 week post-treatment, 3 months follow-up
Change in parental anxiety symptoms, as measured by the General Anxiety Disorder-7 (GAD-7).
The General Anxiety Disorder-7 is a brief self-report measure used to monitor the severity of anxiety symptoms. The scale has 7 items answered on a 4-point Likert scale that ranges from 0 (not at all) to 3 (nearly every day). The total score can range from 0 to 21, with higher scores indicating higher levels of anxiety severity.
Measured: Baseline, within 1 week post-treatment, 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study startSep 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, University of Lisbon
- Responsible party
- Principal investigator, Helena Moreira, University of Coimbra
- Investigators
- Helena Moreira, PhD, Principal investigator, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747131
- Sponsor's protocol ID
- PTDC/PSI-GER/0689/2020
- Status last verified
- May 2023
- First submitted
- 7 Feb 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moreira H, Skvarc D, Gomes-Pereira B, Albuquerque A, Gois AC, Fonseca A, Pereira AM, Caiado B, Paulino B, Santos C, Ehrenreich-May J, Canavarro MC, Saraiva M, Vicente VN, Pereira AI. Study protocol for a randomized controlled trial testing the efficacy of Emotion Detectives In-Out: a blended version of the unified protocol for transdiagnostic treatment of emotional disorders in Portuguese children. BMC Psychol. 2024 Feb 7;12(1):63. doi: 10.1186/s40359-024-01532-z.
PubMed 38326847
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children: A Multicenter Study to Assess the Acceptability, Feasibility and Efficacy of a Blended Format of the Program in Portugal
- ClinicalTrials.gov ID
- NCT05747131
- Acronym / sponsor ID
- PTDC/PSI-GER/0689/2020
- Conditions
- Anxiety Disorders
- Keywords
- Unified Protocol, Children, Blended therapy, Parents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, University of Lisbon
- Study start
- Sep 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Feb 2023 (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 clinical trial is to test the efficacy of a blended format (i.e., a combination of face-to-face and online sessions into one integrated treatment protocol) of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in a sample of children aged between 7 and 12 years with a primary diagnosis of an anxiety disorder or with clinically significant levels of anxiety.
The main questions it aims to answer are:
- Is the proposed intervention (named Emotion Detectives In-Out) feasible and acceptable among Portuguese children with anxiety disorders and their parents?
- Is the Emotion Detectives In-Out intervention as effective as an evidence-based intervention for children's anxiety disorders in reducing anxiety symptomatology and changing secondary outcomes?
- What are the key predictors of adherence to the Emotion Detectives In-Out intervention?
- What are the key predictors of treatment outcomes?
Participants (children and one parent/legal representative) will:
- Participate in an initial interview with a clinical psychologist, who will assess if children and parents meet eligibility criteria.
- Complete an assessment protocol before, during, and after the intervention, as well as three months later.
- Be randomly assigned to one of the two conditions: experimental (Emotion Detectives In-Out) or active control (Coping Cat).
- Participate in one of the two psychological interventions. Researchers will compare the experimental and control groups to see if the Emotion Detectives In-Out intervention is equally efficacious as the Coping Cat intervention.
Detailed description
Childhood emotional disorders, particularly anxiety disorders, are an important public health concern due to their high and increasing prevalence, impact on children's functioning in multiple domains (e.g., family, academic, social), and long-term consequences. However, there is a significant gap between their needs and access to mental healthcare, with most children lacking access to evidence-based treatments (EBT). Several factors can contribute to a lack of adequate mental health care for children, including an insufficient number of trained clinicians, the difficulty of effectively disseminating the multitude of disorder-specific EBTs for emotional disorders to clinicians, and other barriers to face-to-face treatment. An Internet-based intervention can be an effective solution to overcome these difficulties. This project aims to develop and test the efficacy of a blended intervention of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C).
The UP-C is a cognitive-behavioral therapy (CBT) that takes a transdiagnostic approach to treating multiple emotional disorders simultaneously by addressing shared mechanisms underlying these disorders and employing a common set of EBT strategies (e.g., exposure, mindfulness). It is a child-friendly extension of the adult UP that delivers the UP core components in an interactive and child-friendly group format with extensive parent involvement. It has 15 weekly sessions for children and 15 weekly sessions for parents with an approximate duration of 90 minutes each. With a blended approach the researchers aim to improve the delivery of UP-C, by retaining the benefits of face-to-face and online therapy, while mitigating their limitations. This new version is expected to reduce costs of the therapy for families and institutions while also increasing compliance, motivation, uptake of treatment principles, and facilitating generalization of the application of core treatment components.
The blended version of the UP-C, named "Emotion Detectives In-Out" consists of 15 weekly sessions with the children (9 face-to-face group sessions, 4 online self-guided sessions and 2 videoconference sessions). The groups will consist of about 5 to 7 children. Face-to-face sessions have an expected duration of 90 minutes and will be implemented by clinical psychologists with specific training in the program. The online sessions were developed by the research team and are completely self-guided. These sessions last approximately 45 minutes. Parents will be asked to participate in 2 face-to-face sessions, 4 videoconference sessions and 10 self-guided online sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotion Detectives In-Out | Experimental | Behavioral: Emotion Detectives In-OutEmotion Detectives In-Out consists of 15 weekly sessions with the children (9 face-to-face group sessions, 4 online sessions and 2 videoconference sessions). |
| Coping Cat | Active comparator | Behavioral: Coping CatCoping Cat consists of 16 weekly group sessions with the children (5 to 7 children per group) and 2 sessions with the parents. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The child is aged between 7 and 12 years;
- The child has a primary diagnosis of an anxiety disorder or clinically significant anxiety symptoms;
- Both the child and the parent are able to speak, read and understand Portuguese;
- Both the child and the parent have Internet access.
Key exclusion criteria (4 listed)
- Diagnosis of a psychotic disorder, bipolar disorder, intellectual disability or autism spectrum disorder;
- Severe current suicidal ideation;
- The child is not on a stable dose of a psychotropic or other type of medication for at least 1 month prior to T0 assessment;
- The child has previously received CBT with exposure techniques.
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 |
|---|---|---|
| Emotion Detectives In-OutEmotion Detectives In-Out is a blended cognitive-behavioral intervention for children with emotional disorders aged between 7 to 12 years and their parents. It contains group sessions, online self-guided sessions and videoconference sessions. The groups will consist of about 5 to 7 children. Face-to-face sessions have an expected duration of 90 minutes and will be implemented by clinical psychologists with specific training in the program. The online sessions were developed by the research team and are completely self-guided. These sessions last approximately 45 minutes. Parents will be asked to participate in 2 face-to-face sessions, 4 videoconference sessions and 10 self-guided online sessions. It is a transdiagnostic and emotion-focused manualized cognitive-behavioral therapy designed to help children reduce the intensity and frequency of strong and aversive emotional experiences and to help parents reduce parental emotional behaviors. | Behavioural | Emotion Detectives In-Out |
| Coping CatCoping Cat is a cognitive behavioral therapy for children with anxiety aged between 7 to 13 years. Coping Cat consists of 16 weekly group sessions with the children (5 to 7 children per group) and 2 sessions with the parents. Face-to-face sessions have an expected duration of 90 minutes and will be implemented by clinical psychologists. | Behavioural | Coping Cat |
Primary outcome
Change in anxiety symptoms as measured by the Revised Children's Anxiety and Depression Scale (RCADS).
Time frame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up]
The Revised Children's Anxiety and Depression Scale is a 47 item self-report questionnaire that measures symptoms of depression and anxiety in children and adolescents aged 8 - 18. It has 6 subscales: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). It yields a Total Anxiety Scale (the sum of the 5 anxiety subscales) and a Total Anxiety \& Depression Scale (sum of all 6 subscales). The Total Anxiety Scale ranges from 0 to 111, and the Total Anxiety \& Depression scale ranges from 0 to 141, with higher scores indicating increased symptom severity.
Change in anxiety symptoms as measured by the Revised Children's Anxiety and Depression Scale - Parent version (RCADS-P).
Time frame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
The Revised Child Anxiety and Depression Scale - Parent Version (RCADS-P) is a 47 item parent-reported questionnaire that measures symptoms of depression and anxiety in children and adolescents aged 8 - 18. It has 6 subscales: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). It yields a Total Anxiety Scale (the sum of the 5 anxiety subscales) and a Total Anxiety \& Depression Scale (sum of all 6 subscales). The Total Anxiety Scale ranges from 0 to 111, and the Total Anxiety \& Depression scale ranges from 0 to 141, with higher scores indicating increased symptom severity.
Change in anxiety symptoms as measured by the Clinician Global Impression - Improvement scale (CGC-I).
Time frame: within 1 week post-treatment
Higher scores indicate increased symptom worsening.
Change in severity of anxiety symptoms as measured by the Clinician Global Impression - Severity scale (CGC-S).
Time frame: Baseline, within 1 week post-treatment
The Clinician Global Impression - Severity scale is a one-item measure assessing the clinician's perception of the severity of the patient's symptoms, with scores ranging from 1 (not at all ill) to 7 (extremely ill). Higher scores indicate increased symptom severity.
15 secondary outcomes
Change in the interference of anxiety in child's life, as measured by the Child Anxiety Life Interference Scale - Self-Report (CALIS-C)
Time frame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in the interference of anxiety in child's life, as measured by the Child Anxiety Life Interference Scale - Parent's Report (CALIS-P)
Time frame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in children's behavioral avoidance, as measured by the Child Avoidance Measure Self-Report (CAMS)
Time frame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in children's behavioral avoidance, as measured by the Child Avoidance Measure Parent-Report (CAMP)
Time frame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in children's positive and negative affect, as measured by the Positive and Negative Affect Schedule for Children - Short Version (PANAS-C-SF)
Time frame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in children's anxiety sensitivity, as measured by the Children's Anxiety Sensitivity Inventory-Revised (CASI-R).
Time frame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in children's difficulties in emotion expression, as measured by the Emotional Expression Scale for Children (EESC)
Time frame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in children's negative cognitive errors, as measured by the Children's Negative Cognitive Error Questionnaire (CNCEQ)
Time frame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in children's quality of life, as measured by the KIDSCREEN-10 Index (Parent Report)
Time frame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
Change in parental overprotection, as measured by the Parental Anxiety and Overprotection Scale (PAOS)
Time frame: Baseline, within 1 week post-treatment, 3 months follow-up
Change in parental criticism as measured by the Egna Minnen Beträffande Uppfostran Scale (EMBU-P)
Time frame: Baseline, within 1 week post-treatment, 3 months follow-up
Change in parental modeling of intense emotions, as measured by the Parent Emotion Regulation Scale (PERS)
Time frame: Baseline, within 1 week post-treatment, 3 months follow-up
Change in parental inconsistency, as measured by the Parenting Inconsistency Scale
Time frame: Baseline, within 1 week post-treatment, 3 months follow-up
Change in parental depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9).
Time frame: Baseline, within 1 week post-treatment, 3 months follow-up
Change in parental anxiety symptoms, as measured by the General Anxiety Disorder-7 (GAD-7).
Time frame: Baseline, within 1 week post-treatment, 3 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Derived from this study: PubMed 38326847Moreira H, Skvarc D, Gomes-Pereira B, Albuquerque A, Gois AC, Fonseca A, Pereira AM, Caiado B, Paulino B, Santos C, Ehrenreich-May J, Canavarro MC, Saraiva M, Vicente VN, Pereira AI. Study protocol for a randomized controlled trial testing the efficacy of Emotion Detectives In-Out: a blended version of the unified protocol for transdiagnostic treatment of emotional disorders in Portuguese children. BMC Psychol. 2024 Feb 7;12(1):63. doi: 10.1186/s40359-024-01532-z.
- Individual participant dataSharing planned: No
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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.
Ana Isabel Pereira, PhD contact
Helena Moreira, PhD principal investigator
University of Coimbra
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Detectives In-Out and Coping Cat in people with Anxiety Disorders, run by University of Coimbra at 2 sites in Portugal.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helena Moreira, PhD (00351918811714, helena.tcmoreira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety symptoms as measured by the Revised Children's Anxiety and Depression Scale (RCADS). (time frame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up]). 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 NCT05747131, which also lists 1 linked publication.
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 12 May 2023.