Emotional DisordersUP-C/CNCT05798299
Efficacy Study of a Child-centered Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children
A study testing Arm 1: Transdiagnostic intervention and Arm 2: Anxiety-focused intervention in people with Emotional Disorders and Childhood Anxiety, run by University of Lisbon at 1 site in Portugal.
Trial summary
The UP-C is a manualized, cognitive-behavioral, and emotion-focused group intervention with a transdiagnostic approach aimed at the treatment of emotional problems (i.e., anxiety and depression) in children aged 7 to 12 years old. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Emotional Disorders, Childhood Anxiety, Childhood Depression
- What is being tested?
- Arm 1: Transdiagnostic intervention and Arm 2: Anxiety-focused intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Mar 2023to 30 Sep 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
- Children aged 7-12;
- Children whose score in the screening of anxiety symptoms is in a percentile equal to or greater than 80;
- Speaking, reading and understanding Portuguese;
Who cannot join
- Diagnosis of a psychotic disorder, bipolar disorder, intellectual disability or autism spectrum disorder;
- Severe current suicidal/homicidal ideation;
- The child is being subjected to a not yet stable dose of a psychotropic or other type of medication (i.e., modified less than 1 month prior to baseline assessment);
- The child or parents are not fluent in the Portuguese language;
- The child is benefiting from another psychological intervention;
- Presence of the parents and the child cannot be guaranteed in most of the intervention and assessment sessions; the presence of the parents is only required in the parenting sessions and in the evaluation sessions (week 6, after the intervention, and two follow-ups).
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Psychology, University of Lisbon
Lisbon, 1649-013
Ana Maria R Pereira, MsC, 912769592 ext. +351, ana.maria.pereira@edu.ulisboa.pt
Ana Isabel F Pereira, PhD, 217943636 ext. +351, aipereira@psicologia.ulisboa.pt
About this study
Official title: Exploratory Randomized Controlled Trial of a Child-centered Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children (UP-C/C)
The UP-C is a manualized, cognitive-behavioral, and emotion-focused group intervention with a transdiagnostic approach aimed at the treatment of emotional problems (i.e., anxiety and depression) in children aged 7 to 12 years old. This psychological intervention mainly focuses on reducing the intensity and frequency of strong and aversive emotional experiences in children through the development of skills that allow them to face these emotions in a more adaptive way.
By targeting the factors common to emotional disorders (avoidance, emotional reactivity, affective intolerance) we believe this intervention might increase the effectiveness of the treatment of these difficulties (mainly in the cases where comorbidity is present). It may also contribute to therapists' expertise when dealing with different emotional disorders, by not requiring the simultaneous mastery of multiple interventions, to a reduction of costs associated with training and to the planning of more individualized and flexible interventions. This approach could help to make interventions suitable for a set of problems more accessible to the public - which is particularly relevant to the Portuguese context. Thus, to better adapt to the limitations existent in mental health services in Portugal, a modified version of the UP-C was developed by reducing the number of sessions for parents.
Read more
The current study seeks to understand whether this adapted version of the UP-C - the UP-C/C - less demanding in terms of resources required for its application, is effective in reducing children's emotional symptomatology and produces changes on maladaptive parenting strategies used by parents. This version is mostly centered on the child, who participates in 15, 90 minutes, group sessions. In this version of the program, the parents adopt the role of "cotherapists", and support homework completion at home by the child. They also have access to psychoeducational material (in video and written format). Additionally, the UP-C/C includes three parental sessions that focus on parenting strategies shown to be useful in challenging situations. This study also seeks to evaluate child and parent involvement in the intervention and understand its predictors.
These are the specific objectives of the study:
- To evaluate the efficacy of the UP-C/C through a Randomized Controlled Clinical Trial with two conditions (UP-C/C and Coping Cat in group format) on the primary outcomes (child's anxiety and depression symptoms, interference of anxiety and depression in the child's school, social and family functioning), secondary (quality of life, emotional expression and cognitive errors), and on the transdiagnostic factors (avoidance, emotional reactivity, affective intolerance) and on the parental variables (parents' emotional behaviors, orientation towards the child's emotions, symptoms of anxiety and depression);
- To evaluate the involvement of the child and parents in the program (attendance, dropout, active participation) and find out its predictors (age; intensity of symptoms; readiness for change; therapeutic alliance; expectations regarding the intervention).
The main hypothesis of the study, relating to the efficacy study, is the following:
- UP-C/C is expected to have equivalent results to Group Coping Cat in outcomes related to anxiety and quality of life and superior results in outcomes related to depression and transdiagnostic mechanisms.
Read the detailed description
Participants will be recruited from schools located in Lisbon's metropolitan area (Portugal). The selection of participants will be carried out through a two-phase screening, after parental consent and assent from the children are obtained. In both phases, the children will complete a questionnaire that assesses symptoms of anxiety and depression. Children whose score in the screening of anxiety symptoms is in a percentile equal to or greater than 80 will be selected at both assessment times. Families of children selected through the screening are invited to an individual assessment session. In this session, a brief set of questions to parents is asked to ensure their child's eligibility, and current difficulties are explored in more detail. If the necessary criteria are met, the pre-intervention evaluation processes take place (child and caregivers complete a set of measures).
To access the efficacy of the UP-C/C, this intervention will be compared with a cognitive-behavioral intervention previously shown to be effective in the treatment of anxiety disorders, the Coping Cat program in a group format. Thus, once the recruitment and evaluation of eligibility criteria is finished, the children and their parents will be randomly allocated to one of two conditions:
- experimental group (i.e., children and parents who benefit from the UP-C/C program);
- control group (i.e., children who benefit from the Coping Cat, group format).
In both conditions, 15/16 weekly sessions with the children will take place in groups of 5 to 7 participants. Therapist's and children's manuals are available. The groups will be conducted by clinical psychologists integrated in the research team. All therapists received training to conduct the intervention and will receive weekly supervision by the project supervisor. Every session will be observed and evaluated by an external observer through a checklist.
Regarding the primary and secondary outcomes, transdiagnostic mechanisms and parental variables, the study includes 5 assessment times - at pre-intervention, 6 weeks after the start of the intervention, after the intervention ends and at two follow-ups, 3 and 6 months after the end of the intervention. The variables related to the therapeutic process are evaluated at each session (active participation, assessment of program conduction, therapeutic alliance) and in the 1st session (readiness for change). Informed consent, from the parents and the children, will be sought at each assessment time. Consent protocol includes a paragraph, that explains how data will be recorded and who has access to it. Only information relevant to the study is collected.
For the analysis of the effects of the intervention, a multivariate analysis of variance (MANOVA) (SPSS 26.0) will be used. To assess participants' engagement in the UP-C/C, data will be collected from all sessions and percentages of attendance and dropout will be calculated. ANOVA analysis of variance and Chi-Square tests (SPSS 26.0) will be used to examine differences between the Experimental Group and the Control Group in attendance/active participation and dropout, respectively. To explore predictors of attendance/active participation and dropout Multiple Regressions and Logistic Regressions (SPSS 26.0) will be used, respectively.
Assuming a mean effect size of 0.4 on improvement in depressive symptomatology, an alpha=0.05, and power=0.8, for a 2-group design with 5 repeated measures, the total sample size required is 80 (G*Power). Given an expected dropout of 17%, it will be necessary to recruit a minimum of approximately 94 children. Thus, a sample of 47 children in the experimental group and 47 in the control group is expected. 7 UP-C/C groups with a maximum number of 7 children will be conducted. To allow for a satisfactory number of participants, the therapeutic groups will be carried out in two periods (March 2023 to July 2023 and October 2024 to February 2024).
Missing data due to participant's dropout will be handled by intention-to-treat principles, estimated using the last observation carried forward (LOCF) method.
- Conditions
- Emotional Disorders, Childhood Anxiety, Childhood Depression
- Being tested
- Arm 1: Transdiagnostic intervention, Arm 2: Anxiety-focused intervention
- Keywords
- Randomized controlled trial, Anxiety Disorders, Mood disorders, Transdiagnostic Intervention, UP-C, UP-C/C, Parenting
- Medical subject headings
- Anxiety Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: Transdiagnostic interventionBehavioural
Also called UP-C/C, Unified Protocol for Children - Child-Centered Version, Emotion Detectives - Child-Centered Version
The UP-C/C consists of 15 weekly sessions for children, each lasting 90 minutes. It is also composed by three sessions for parents and a meeting with the family prior to the exposure sessions. Parents have access to weekly psychoeducational material (in written and in video format) and help the children with homework completion.
Arm 2: Anxiety-focused interventionBehavioural
The Coping Cat in group format is a cognitive-behavioral evidence-based intervention for anxiety problems. It is composed by 16 90-minute sessions for children and two parenting sessions.
| Study group | Role | What they receive |
|---|---|---|
| UP-C/C | Experimental | UP-C/C intervention - 15 weekly sessions for children; 3 group sessions for parents; 1 family meeting before exposure sessions. Receives: Behavioral: Arm 1: Transdiagnostic intervention |
| Coping Cat, Group Format | Active comparator | Coping Cat in group format intervention - 16 weekly sessions for children; 2 individual sessions for parents. Receives: Behavioral: Arm 2: Anxiety-focused intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the children's anxiety and depression
Measured with the Revised Children's Anxiety and Depression Scale (RCADS) (Child and Parent Version)
Child version: Self-report questionnaire composed by 47 items and 6 subscales, including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive-compulsive disorder, and major depression. It also includes a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales).
Parent version: Measure completed by the parents that includes 6 subscales to assess the child's anxiety and depression symptoms.
Measured: Recruitment/Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in the children's severity of psychopathology and improvement
Measured with an adaptation of the Clinical Global Impression (CGI). Brief assessment of the patient's global functioning before and after the intervention, the CGI is composed by an illness' severity scale and a scale evaluating changes in the patient's symptoms relative to their condition at the start of the intervention. Higher scores are indicative of higher severity of psychopathology.
Measured: Baseline, Mid-treatment (6 weeks); Post treatment (15 weeks)
Changes in the child's anxiety life interference
Measured with the Child Anxiety Life Interference Scale (Child and Parent Versions)
Child version: Questionnaire for evaluating the influence of the child's symptoms on their school, social and family functioning.
Parent version: Measure for assessing the influence of the child's symptoms on their school, social and family functioning through parental report.
Measured: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Secondary outcomes (12)
Changes in the children's behavioral avoidance
Measured with the Child- and Parent-Report Measures of Behavioral Avoidance Related to Childhood Anxiety Disorders (CAMS and CAMP). Higher scores indicate higher levels of children's behavioral avoidance.
Measured: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in the children's negative affect
Measured with the Positive and Negative Affect for Children (PANAS-C). PANAS-C is composed by 10 items for the assessment of Positive Affect and Negative Affect, organized in two scales. Higher scores are indicative of higher levels of children's positive and negative affect, respectively.
Measured: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in the children's anxiety sensitivity
Measured by Children's Anxiety Sensitivity Inventory-Revised (CASI-R). Higher scores are indicative of higher levels of anxiety sensitivity.
Measured: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in the children's cognitive distortions
Measured by the Children's Negative Cognitive Error Questionnaire (CNCEQ). The CNCEQ assesses four types of cognitive errors and yields a Total Score for each type of cognitive error, a Total Score for areas of content and a Total Score for cognitive errors. Higher values are indicative of a greater presence of cognitive errors.
Measured: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in the children's emotional expression and emotion awareness
Measured by the Emotional Expression Scale for Children (EESC). In this measure, higher scores correspond to higher levels of difficulties in children's emotional expression and emotion awareness.
Measured: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in the children's life quality
Measured by the Kidscreen-10 index (parent version), a brief measure that assesses the quality of life of the children through parental report.
Measured: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in parent's anxiety
Measured by the Generalized Anxiety Disorder Scale (GAD-7), a brief self-report questionnaire with 7 items that assesses the presence of anxiety symptoms. Higher scores are indicative of higher levels of anxiety.
Measured: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks); Follow-up (3 and 6 months)
Changes in parent's depression
Measured by the Patient Health Questionnaire 9 (PHQ-9) that evaluates symptoms of major depression through 9 items. Higher scores are indicative of higher levels of depression.
Measured: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks); Follow-up (3 and 6 months)
Changes in parental overprotection
Measured by the Parental anxiety and overprotection scale (PAOS). Higher scores are indicative of higher levels parental overprotection.
Measured: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 months and 6 months)
Changes in parental inconsistency and permissiveness
Measured by Parenting Styles \& Dimensions Questionnaire. Only the permissiveness subscale will be used. Higher scores are indicative of higher levels of parental inconsistency and permissiveness.
Measured: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in parental criticism
Measured by the EMBU-P, a questionnaire that assesses parental styles. In the current study, only the rejection subscale will be used, which assesses parental rejection and criticism. Higher scores indicate higher levels of rejection and parental criticism.
Measured: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in the modeling of negative emotions
Measured by The Parent Emotion Regulation Scale (PERS). In the present study only parents' lack of emotional control scale will be used, which assesses the lack of ability of parents to modulate their own negative emotions in the presence of the child. Higher scores are indicative of higher levels of modeling of negative emotions.
Measured: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start15 Mar 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional 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
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, University of Coimbra
- Responsible party
- Principal investigator, Ana Isabel de Freitas Pereira, University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798299
- Sponsor's protocol ID
- 2020.06835.BD
- Acronym
- UP-C/C
- Status last verified
- Apr 2023
- First submitted
- 17 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Randomized Controlled Trial of a Child-centered Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children (UP-C/C)
- ClinicalTrials.gov ID
- NCT05798299
- Acronym / sponsor ID
- UP-C/C / 2020.06835.BD
- Conditions
- Emotional Disorders, Childhood Anxiety, Childhood Depression
- Keywords
- Randomized controlled trial, Anxiety Disorders, Mood disorders, Transdiagnostic Intervention, UP-C, UP-C/C, Parenting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, University of Coimbra
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 4 Apr 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 UP-C is a manualized, cognitive-behavioral, and emotion-focused group intervention with a transdiagnostic approach aimed at the treatment of emotional problems (i.e., anxiety and depression) in children aged 7 to 12 years old. This psychological intervention mainly focuses on reducing the intensity and frequency of strong and aversive emotional experiences in children through the development of skills that allow them to face these emotions in a more adaptive way.
By targeting the factors common to emotional disorders (avoidance, emotional reactivity, affective intolerance) we believe this intervention might increase the effectiveness of the treatment of these difficulties (mainly in the cases where comorbidity is present). It may also contribute to therapists' expertise when dealing with different emotional disorders, by not requiring the simultaneous mastery of multiple interventions, to a reduction of costs associated with training and to the planning of more individualized and flexible interventions. This approach could help to make interventions suitable for a set of problems more accessible to the public - which is particularly relevant to the Portuguese context. Thus, to better adapt to the limitations existent in mental health services in Portugal, a modified version of the UP-C was developed by reducing the number of sessions for parents.
The current study seeks to understand whether this adapted version of the UP-C - the UP-C/C - less demanding in terms of resources required for its application, is effective in reducing children's emotional symptomatology and produces changes on maladaptive parenting strategies used by parents. This version is mostly centered on the child, who participates in 15, 90 minutes, group sessions. In this version of the program, the parents adopt the role of "cotherapists", and support homework completion at home by the child. They also have access to psychoeducational material (in video and written format). Additionally, the UP-C/C includes three parental sessions that focus on parenting strategies shown to be useful in challenging situations. This study also seeks to evaluate child and parent involvement in the intervention and understand its predictors.
These are the specific objectives of the study:
- To evaluate the efficacy of the UP-C/C through a Randomized Controlled Clinical Trial with two conditions (UP-C/C and Coping Cat in group format) on the primary outcomes (child's anxiety and depression symptoms, interference of anxiety and depression in the child's school, social and family functioning), secondary (quality of life, emotional expression and cognitive errors), and on the transdiagnostic factors (avoidance, emotional reactivity, affective intolerance) and on the parental variables (parents' emotional behaviors, orientation towards the child's emotions, symptoms of anxiety and depression);
- To evaluate the involvement of the child and parents in the program (attendance, dropout, active participation) and find out its predictors (age; intensity of symptoms; readiness for change; therapeutic alliance; expectations regarding the intervention).
The main hypothesis of the study, relating to the efficacy study, is the following:
- UP-C/C is expected to have equivalent results to Group Coping Cat in outcomes related to anxiety and quality of life and superior results in outcomes related to depression and transdiagnostic mechanisms.
Detailed description
Participants will be recruited from schools located in Lisbon's metropolitan area (Portugal). The selection of participants will be carried out through a two-phase screening, after parental consent and assent from the children are obtained. In both phases, the children will complete a questionnaire that assesses symptoms of anxiety and depression. Children whose score in the screening of anxiety symptoms is in a percentile equal to or greater than 80 will be selected at both assessment times. Families of children selected through the screening are invited to an individual assessment session. In this session, a brief set of questions to parents is asked to ensure their child's eligibility, and current difficulties are explored in more detail. If the necessary criteria are met, the pre-intervention evaluation processes take place (child and caregivers complete a set of measures).
To access the efficacy of the UP-C/C, this intervention will be compared with a cognitive-behavioral intervention previously shown to be effective in the treatment of anxiety disorders, the Coping Cat program in a group format. Thus, once the recruitment and evaluation of eligibility criteria is finished, the children and their parents will be randomly allocated to one of two conditions:
- experimental group (i.e., children and parents who benefit from the UP-C/C program);
- control group (i.e., children who benefit from the Coping Cat, group format).
In both conditions, 15/16 weekly sessions with the children will take place in groups of 5 to 7 participants. Therapist's and children's manuals are available. The groups will be conducted by clinical psychologists integrated in the research team. All therapists received training to conduct the intervention and will receive weekly supervision by the project supervisor. Every session will be observed and evaluated by an external observer through a checklist.
Regarding the primary and secondary outcomes, transdiagnostic mechanisms and parental variables, the study includes 5 assessment times - at pre-intervention, 6 weeks after the start of the intervention, after the intervention ends and at two follow-ups, 3 and 6 months after the end of the intervention. The variables related to the therapeutic process are evaluated at each session (active participation, assessment of program conduction, therapeutic alliance) and in the 1st session (readiness for change). Informed consent, from the parents and the children, will be sought at each assessment time. Consent protocol includes a paragraph, that explains how data will be recorded and who has access to it. Only information relevant to the study is collected.
For the analysis of the effects of the intervention, a multivariate analysis of variance (MANOVA) (SPSS 26.0) will be used. To assess participants' engagement in the UP-C/C, data will be collected from all sessions and percentages of attendance and dropout will be calculated. ANOVA analysis of variance and Chi-Square tests (SPSS 26.0) will be used to examine differences between the Experimental Group and the Control Group in attendance/active participation and dropout, respectively. To explore predictors of attendance/active participation and dropout Multiple Regressions and Logistic Regressions (SPSS 26.0) will be used, respectively.
Assuming a mean effect size of 0.4 on improvement in depressive symptomatology, an alpha=0.05, and power=0.8, for a 2-group design with 5 repeated measures, the total sample size required is 80 (G*Power). Given an expected dropout of 17%, it will be necessary to recruit a minimum of approximately 94 children. Thus, a sample of 47 children in the experimental group and 47 in the control group is expected. 7 UP-C/C groups with a maximum number of 7 children will be conducted. To allow for a satisfactory number of participants, the therapeutic groups will be carried out in two periods (March 2023 to July 2023 and October 2024 to February 2024).
Missing data due to participant's dropout will be handled by intention-to-treat principles, estimated using the last observation carried forward (LOCF) method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UP-C/C | Experimental | Behavioral: Arm 1: Transdiagnostic interventionUP-C/C intervention - 15 weekly sessions for children; 3 group sessions for parents; 1 family meeting before exposure sessions. |
| Coping Cat, Group Format | Active comparator | Behavioral: Arm 2: Anxiety-focused interventionCoping Cat in group format intervention - 16 weekly sessions for children; 2 individual sessions for parents. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 7-12;
- Children whose score in the screening of anxiety symptoms is in a percentile equal to or greater than 80;
- Speaking, reading and understanding Portuguese;
Key exclusion criteria (6 listed)
- Diagnosis of a psychotic disorder, bipolar disorder, intellectual disability or autism spectrum disorder;
- Severe current suicidal/homicidal ideation;
- The child is being subjected to a not yet stable dose of a psychotropic or other type of medication (i.e., modified less than 1 month prior to baseline assessment);
- The child or parents are not fluent in the Portuguese language;
- The child is benefiting from another psychological intervention;
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 |
|---|---|---|
| Arm 1: Transdiagnostic interventionAlso: UP-C/C, Unified Protocol for Children - Child-Centered Version, Emotion Detectives - Child-Centered VersionThe UP-C/C consists of 15 weekly sessions for children, each lasting 90 minutes. It is also composed by three sessions for parents and a meeting with the family prior to the exposure sessions. Parents have access to weekly psychoeducational material (in written and in video format) and help the children with homework completion. | Behavioural | UP-C/C |
| Arm 2: Anxiety-focused interventionThe Coping Cat in group format is a cognitive-behavioral evidence-based intervention for anxiety problems. It is composed by 16 90-minute sessions for children and two parenting sessions. | Behavioural | Coping Cat, Group Format |
Primary outcome
Changes in the children's anxiety and depression
Time frame: Recruitment/Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Measured with the Revised Children's Anxiety and Depression Scale (RCADS) (Child and Parent Version) Child version: Self-report questionnaire composed by 47 items and 6 subscales, including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive-compulsive disorder, and major depression. It also includes a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). Parent version: Measure completed by the parents that includes 6 subscales to assess the child's anxiety and depression symptoms.
Changes in the children's severity of psychopathology and improvement
Time frame: Baseline, Mid-treatment (6 weeks); Post treatment (15 weeks)
Measured with an adaptation of the Clinical Global Impression (CGI). Brief assessment of the patient's global functioning before and after the intervention, the CGI is composed by an illness' severity scale and a scale evaluating changes in the patient's symptoms relative to their condition at the start of the intervention. Higher scores are indicative of higher severity of psychopathology.
Changes in the child's anxiety life interference
Time frame: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Measured with the Child Anxiety Life Interference Scale (Child and Parent Versions) Child version: Questionnaire for evaluating the influence of the child's symptoms on their school, social and family functioning. Parent version: Measure for assessing the influence of the child's symptoms on their school, social and family functioning through parental report.
12 secondary outcomes
Changes in the children's behavioral avoidance
Time frame: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in the children's negative affect
Time frame: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in the children's anxiety sensitivity
Time frame: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in the children's cognitive distortions
Time frame: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in the children's emotional expression and emotion awareness
Time frame: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in the children's life quality
Time frame: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in parent's anxiety
Time frame: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks); Follow-up (3 and 6 months)
Changes in parent's depression
Time frame: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks); Follow-up (3 and 6 months)
Changes in parental overprotection
Time frame: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 months and 6 months)
Changes in parental inconsistency and permissiveness
Time frame: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in parental criticism
Time frame: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Changes in the modeling of negative emotions
Time frame: Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1: Transdiagnostic intervention and Arm 2: Anxiety-focused intervention in people with Emotional Disorders and Childhood Anxiety, run by University of Lisbon at 1 site 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 3 inclusion and 6 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 4 Apr 2023. 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 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 Ana Maria R Pereira, MsC (912769592 ext. +351, ana.maria.pereira@edu.ulisboa.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the children's anxiety and depression (time frame: Recruitment/Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2023.