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Unified Protocol for Children: A Randomized Controlled Trial for the Portuguese Population (UP-C)

Primary Purpose

Anxiety Disorders, Mood Disorders, Emotional Disorder

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Emotion Detectives: Unified protocol for transdiagnostic treatment of emotional disorders in children (UP-C)
ABC of Emotions
Sponsored by
University of Coimbra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring emotional disorders, anxiety and mood disorders, children, parenting, transdiagnostic, unified protocol, randomized controlled trial

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children aged 6-12
  • Primary diagnosis of an anxiety and/or depression disorder
  • Speaking, reading and understanding Portuguese

Exclusion Criteria:

  • 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.

Sites / Locations

  • Faculty of Psychology and Education Sciences, University of Coimbra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group (UP-C intervention)

Control group (ABC of emotions intervention)

Arm Description

UP-C intervention 15 weekly sessions, for children and parents

ABC of emotions - a psychoeducational intervention 5 sessions every 3 weeks for children

Outcomes

Primary Outcome Measures

Changes of children's anxiety and depression
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.

Secondary Outcome Measures

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

Full Information

First Posted
May 31, 2021
Last Updated
October 10, 2023
Sponsor
University of Coimbra
Collaborators
Fundação para a Ciência e a Tecnologia, Centro Hospitalar Tondela-Viseu
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1. Study Identification

Unique Protocol Identification Number
NCT04932421
Brief Title
Unified Protocol for Children: A Randomized Controlled Trial for the Portuguese Population
Acronym
UP-C
Official Title
Emotion Detectives - Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children: A Randomized Controlled Trial in the Portuguese Population
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Coimbra
Collaborators
Fundação para a Ciência e a Tecnologia, Centro Hospitalar Tondela-Viseu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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. 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: experimental group (i.e., children and parents who benefit from the UP-C program). 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Mood Disorders, Emotional Disorder, Emotional; Disorder, Childhood, With Anxiety and Fearfulness, Child Mental Disorder, Parenting
Keywords
emotional disorders, anxiety and mood disorders, children, parenting, transdiagnostic, unified protocol, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
experimental group (i.e., children and parents who benefit from the UP-C program). control group (i.e., children who benefit from a psychoeducational intervention program, named "ABC of Emotions").
Masking
Investigator
Masking Description
Single-blind - the investigator is unaware of the intervention assignment
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group (UP-C intervention)
Arm Type
Experimental
Arm Description
UP-C intervention 15 weekly sessions, for children and parents
Arm Title
Control group (ABC of emotions intervention)
Arm Type
Active Comparator
Arm Description
ABC of emotions - a psychoeducational intervention 5 sessions every 3 weeks for children
Intervention Type
Behavioral
Intervention Name(s)
Emotion Detectives: Unified protocol for transdiagnostic treatment of emotional disorders in children (UP-C)
Other Intervention Name(s)
UP-C
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
ABC of Emotions
Intervention Description
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).
Primary Outcome Measure Information:
Title
Changes of children's anxiety and depression
Time Frame
Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Title
Changes of children's severity of psychopathology and improvement
Description
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.
Time Frame
Baseline, Póst treatment (15 weeks)
Secondary Outcome Measure Information:
Title
Changes of child anxiety life interference
Description
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.
Time Frame
Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Title
Changes of children's psychological flexibility
Description
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.
Time Frame
Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Title
Changes of children's behavioral avoidance
Description
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.
Time Frame
Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Title
Changes of children's negative affect
Description
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.
Time Frame
Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Title
Changes of children's negative emotionality
Description
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.
Time Frame
Baseline, Póst-treatment (15 weeks)
Title
Changes of children's anxiety sensitivity
Description
Measured by Children's Anxiety Sensitivity Inventory-Revised (CASI-R). Higher scores are indicative of higher levels of anxiety sensitivity.
Time Frame
Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Title
Changes of children's tolerance of negative emotions
Description
Measured by Distress Tolerance Scale (DTS). Higher scores are indicative of lower levels of tolerance to feel negative emotions.
Time Frame
Baseline, Mid-treatment (7 weeks), Póst treatment (15 weeks), Follow-up 3 months
Title
Changes of children's mindfulness skills
Description
Measured by The Child and Adolescent Mindfulness Measure (CAMM). Higher scores are indicative of higher levels of children's mindfulness skills.
Time Frame
Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Title
Changes of children's negative cognitive error
Description
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.
Time Frame
Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Title
Changes of children's emotional expression and emotion awareness
Description
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.
Time Frame
Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Title
Changes of parent's anxiety and depression
Description
Measured by Hospital Anxiety and Depression Scale (HADS). Higher scores are indicative of higher levels of anxiety and depression.
Time Frame
Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks)
Title
Changes of parental anxiety, parental overprotection and parental support of children's coping behaviors
Description
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.
Time Frame
Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Title
Changes of parental neuroticism
Description
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.
Time Frame
Baseline, Póst-treatment (15 weeks)
Title
Changes of parental inconsistency and permissiveness
Description
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.
Time Frame
Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Title
Changes of parental criticism
Description
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.
Time Frame
Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Title
Changes of shaping of negative emotions
Description
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.
Time Frame
Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Title
Changes of mindfulness in parenting
Description
Measured by Interpersonal Mindfulness in Parenting Scale (IMP). Higher scores are indicative of higher levels of mindfulness in parenting.
Time Frame
Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Other Pre-specified Outcome Measures:
Title
Feasibility of the program by adherence and dropout rate
Description
Measured through the number of completers and users that dropped out from the intervention before completing it and through the involvement of the participants in the homework (through a record made at each session).
Time Frame
Póst-treatment (15 weeks)
Title
Acceptability of the program
Description
Measured through specific questions (developed by the researchers) to assess acceptability of the program and to assess satisfaction for each session and for the global intervention - for parents and children; Measured by Parent Motivation Inventory - PMI (to measure parent motivation to participate in treatment).
Time Frame
Póst-treatment (15 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged 6-13 Primary diagnosis of an anxiety and/or depression disorder Speaking, reading and understanding Portuguese Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brígida Caiado, MsC
Organizational Affiliation
Faculty of Psychology and Education Sciences, University of Coimbra
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Psychology and Education Sciences, University of Coimbra
City
Coimbra
State/Province
Coimbra, Portugal
ZIP/Postal Code
300-115
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35162806
Citation
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.
Results Reference
result
Links:
URL
http://protocolounificadoc.wixsite.com/home
Description
Project webiste
URL
http://www.facebook.com/detetivesemocoesprotocolounificadocriancas
Description
Project facebook

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

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