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Anxiety DisordersUP-CNCT04932421

Unified Protocol for Children: A Randomized Controlled Trial for the Portuguese Population

A study testing Emotion Detectives: Unified protocol for transdiagnostic treatment of emotional disorders in children (UP-C) and ABC of Emotions in people with Anxiety Disorders and Mood Disorders, run by University of Coimbra at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) is a transdiagnostic and emotion-focused cognitive-behavioral group intervention for children aged 6-12 years old with emotion disorders (i.e., anxious and/or mood disorders) and their parents. Read more about this study

Who is it for?
Ages 6 to 13 years
What is being tested?
Emotion Detectives: Unified protocol for transdiagnostic treatment of emotional disorders in children (UP-C) and ABC of Emotions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
1 sitePortugal
Study dates
1 Mar 2021to 30 Nov 2022
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 6 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children aged 6-13
  • Primary diagnosis of an anxiety and/or depression disorder
  • Speaking, reading and understanding Portuguese

Who cannot join

  • Diagnosis of a psychotic disorder, bipolar disorder or intellectual disability;
  • Severe current suicidal/homicidal 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.

Trial locations and contacts

1 site in 1 country.

Portugal1 site
  • Faculty of Psychology and Education Sciences, University of Coimbra

    Coimbra, Coimbra, Portugal, 300-115

Other trials in Portugal

About this study

Official title: Emotion Detectives - Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children: A Randomized Controlled Trial in the Portuguese Population

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) is a transdiagnostic and emotion-focused cognitive-behavioral group intervention for children aged 6-12 years old with emotion disorders (i.e., anxious and/or mood disorders) and their parents.

UP-C consists of 15 weekly group sessions and unifies cognitive-behavioral, contextual (e.g., mindfulness) and parental training techniques, for parents and children, aimed at reducing the intensity and frequency of strong and aversive emotional experiences in children and their clinical symptomatology.

Read more

The present study aims to assess the feasibility, acceptability and efficacy of the UP-C in the Portuguese population in reducing children's anxiety/depression symptoms. It also aims to investigate which mechanisms explain the therapeutic change.

Participants will be recruited at child mental health services and schools from Central Portugal and also through online dissemination of the study.

A randomized controlled trial (RCT) will be conducted in a sample of children aged 6-13 years old with emotional disorders and their parents in order to answer the critical question of whether the UP-C is more efficacious in reducing children's symptomatology than a psychoeducational group intervention (active control group).

Once the eligibility criteria are met (assessed by the project researchers) parents and children will be randomly assigned to one of two study conditions:

  1. experimental group (i.e., children and parents who benefit from the UP-C program).
  2. control group (i.e., children who benefit from a psychoeducational intervention program, named "ABC of Emotions").

Parents and children from both groups will complete several psychometrically robust and developmentally appropriate measures at baseline (T0), mid-treatment (only at week 7 of the UP-C; T1), post treatment (T2) and at 3 months follow-up (T3).

Being tested
Emotion Detectives: Unified protocol for transdiagnostic treatment of emotional disorders in children (UP-C), ABC of Emotions
Keywords
emotional disorders, anxiety and mood disorders, children, parenting, transdiagnostic, unified protocol, randomized controlled trial
Medical subject headings
Anxiety Disorders, Mood Disorders, Neurodevelopmental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotion Detectives: Unified protocol for transdiagnostic treatment of emotional disorders in children (UP-C)Behavioural

    Also called UP-C

    UP-C is a transdiagnostic and emotion-focused cognitive-behavioral group intervention for children aged 6-13 years old with emotions disorders (i.e., anxious and/or mood disorders) and their parents. UP-C unifies cognitive-behavioral, contextual (eg. mindfulness) and parental training techniques aiming to reduce the intensity and frequency of children's clinical symptomatology.

    The intervention consists of 15 weekly group sessions (90 minutes per session; 5-8 children and parents per group) conducted by at least two clinical psychologists trained in the UP-C. The sessions start with the parents and children together (15 minutes); then, one psychologist conduct the session with the group of children while the other psychologist conduct the session with the group of parents, simultaneously (60 minutes); finally, the session ends with the group together (15 minutes). This is a structured and manualized intervention with a manual for the therapist and a workbook for the child and parents.

  • ABC of EmotionsOther

    ABC of Emotions is a psychoeducational group intervention for children with anxiety and/or mood disorders, aged between 6 to 13 years. ABC of Emotions consists of 5 group psychoeducation sessions (about 90 minutes per session; 5-8 children per group). This is a structured and manualized intervention, with a manual for the therapist and a workbook for the child.

    The contents of the sessions were developed by the researchers of this study and are based on classic psychoeducational cognitive-behavioral therapies (CBT) strategies. Since anxiety disorders are more frequent in childhood than mood disorders (e.g., Merikangas et al., 2009), this program is essentially based on psychoeducation materials focused on emotions such as anxiety and fear. However, the same materials are available in an attachment, adapted for use with children to whom the main emotion is not fear/anxiety, but sadness (as in mood disorders).

Study groups in NCT04932421
Study groupRoleWhat they receive
Experimental group (UP-C intervention)ExperimentalUP-C intervention 15 weekly sessions, for children and parents
Receives: Behavioral: Emotion Detectives: Unified protocol for transdiagnostic treatment of emotional disorders in children (UP-C)
Control group (ABC of emotions intervention)Active comparatorABC of emotions - a psychoeducational intervention 5 sessions every 3 weeks for children
Receives: Other: ABC of Emotions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of children's anxiety and depression

    Measured: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

  2. Changes of children's severity of psychopathology and improvement

    Measured with an adaptation of Clinical Global Impression (CGI). The CGI is composed by a severity of illness scale and a scale evaluating changes from the initiation of treatment. Higher scores are indicative of higher severity of psychopathology and lower improvement from the initiation of treatment.

    Measured: Baseline, Póst treatment (15 weeks)

Secondary outcomes (17)
  1. Changes of child anxiety life interference

    Measured by Child Anxiety Life Interference Scale - self-report (CALIS-C) and parent's report (CALIS-P). The child form is composed by a single scale and the parent form is composed by two subscales (Child Interference Subscale and Family Interference Subscale). Higher scores are indicative of greater interference of anxiety symptoms in the life of the children and the family.

    Measured: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

  2. Changes of children's psychological flexibility

    Measured by The Avoidance and Fusion Questionnaire - Youth (AFQ-Y). AFQ-Y assess children's psychological inflexibility, namely children's experiential avoidance and cognitive fusion. Higher scores are indicative of higher levels of children's psychological inflexibility.

    Measured: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

  3. Changes of children's behavioral avoidance

    Measured by Child- and Parent-Report Measures of Behavioral Avoidance Related to Childhood Anxiety Disorders (CAMS and CAMP). Higher scores are indicative of higher levels of children's behavioral avoidance.

    Measured: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

  4. Changes of children's negative affect

    Measured by Positive and Negative Affect for Children (PANAS-C). PANAS-C is composed by two independent subscales: Positive Affect and Negative Affect. Higher scores are indicative of higher levels of children's positive and negative affect, respectively.

    Measured: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

  5. Changes of children's negative emotionality

    Measured by School-Age Temperament Inventory (SATI). It is composed by five dimensions: negative emotionality, inhibition, adaptability, activity, and persistence. Only the subscale of negative emotionality is used in this study. Higher scores are indicative of higher levels of negative emotionality.

    Measured: Baseline, Póst-treatment (15 weeks)

  6. Changes of 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 (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

  7. Changes of children's tolerance of negative emotions

    Measured by Distress Tolerance Scale (DTS). Higher scores are indicative of lower levels of tolerance to feel negative emotions.

    Measured: Baseline, Mid-treatment (7 weeks), Póst treatment (15 weeks), Follow-up 3 months

  8. Changes of children's mindfulness skills

    Measured by The Child and Adolescent Mindfulness Measure (CAMM). Higher scores are indicative of higher levels of children's mindfulness skills.

    Measured: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

  9. Changes of children's negative cognitive error

    Measured by Children's Negative Cognitive Error Questionnaire (CNCEQ). It assesses four types of cognitive errors derived theoretically: catastrophizing, overgeneralization, personalizing, and selective abstraction. CNCEQ yields a Total Score for each type of cognitive error, a Total Score for areas of content (social, academic, Atlético) and a Total Score for cognitive errors. Higher values correspond to more cognitive errors.

    Measured: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

  10. Changes of children's emotional expression and emotion awareness

    Measured by Emotional Expression Scale for Children (EESC). Higher scores are indicative of higher levels of difficulties in children's emotional expression and emotion awareness.

    Measured: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

  11. Changes of parent's anxiety and depression

    Measured by Hospital Anxiety and Depression Scale (HADS). Higher scores are indicative of higher levels of anxiety and depression.

    Measured: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks)

  12. Changes of parental anxiety, parental overprotection and parental support of children's coping behaviors

    Measured by Parental anxiety and overprotection scale (PAOS). Higher scores are indicative of higher levels of parental anxiety, parental overprotection and parental support of children's coping behaviors.

    Measured: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

  13. Changes of parental neuroticism

    Measured by NEO Five-Factor Inventory (NEO-FFI). It assesses the five traits of personality defined in the Five Factor Theory of Personality: Openness, Conscientiousness, Extraversion, Agreeableness and Neuroticism. In the present study only Neuroticism subscale was used. Higher scores are indicative of higher levels of neuroticism.

    Measured: Baseline, Póst-treatment (15 weeks)

  14. Changes of parental inconsistency and permissiveness

    Measured by Parenting Styles \& Dimensions Questionnaire. Only the permissiveness subscale was used with higher scores being indicative of higher levels of parental inconsistency and permissiveness.

    Measured: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

  15. Changes of parental criticism

    Measured by EMBU-P (egna minnen beträffande uppfostran). It assesses four dimensions: emotional support, rejection, control attempt and sibling preference. In this study, only the rejection subscale was used, which assesses parental rejection and criticism. Higher scores indicate higher levels of rejection and parental criticism.

    Measured: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

  16. Changes of shaping of negative emotions

    Measured by The Parent Emotion Regulation Scale (PERS). It assesses four dimensions: parents' orientation to the child's emotions, parents' avoidance of the child's emotions, parents' lack of emotional control and parents' acceptance of the child's and their own emotions. In the present study only parents' lack of emotional control scale was used. This subscale assesses the lack of ability to modulate their own negative emotions in the presence of the child. Higher scores are indicative of higher levels of shaping of negative emotions.

    Measured: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

  17. Changes of mindfulness in parenting

    Measured by Interpersonal Mindfulness in Parenting Scale (IMP). Higher scores are indicative of higher levels of mindfulness in parenting.

    Measured: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2021
  2. Study start1 Mar 2021
  3. Primary completion30 Aug 2022
  4. Study completion30 Nov 2022

Resources

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
Model description
1. experimental group (i.e., children and parents who benefit from the UP-C program). 2. control group (i.e., children who benefit from a psychoeducational intervention program, named "ABC of Emotions").
Masking
Single blind
Who is masked
Investigator
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04932421
Sponsor's protocol ID
Univeristy of Coimbra
Acronym
UP-C
Status last verified
Oct 2023
First submitted
31 May 2021
Last updated
12 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Caiado B, Gois A, Pereira B, Canavarro MC, Moreira H. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in Portugal: Feasibility Study Results. Int J Environ Res Public Health. 2022 Feb 4;19(3):1782. doi: 10.3390/ijerph19031782.

    PubMed 35162806

Questions about this trial

What is this clinical trial studying?

A study testing Emotion Detectives: Unified protocol for transdiagnostic treatment of emotional disorders in children (UP-C) and ABC of Emotions in people with Anxiety Disorders and Mood Disorders, run by University of Coimbra 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 3 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 12 Oct 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?

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?

Changes of children's anxiety and depression (time frame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months). The study lists 2 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 NCT04932421, 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 Oct 2023; AzTrials last refreshed its copy on 30 Oct 2026.

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