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

Anxiety Disorders Clinical Trial

— UP-C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04932421
• Other study ID #: Univeristy of Coimbra
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: October 2023
• Source: University of Coimbra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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: 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: November 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Child Mental Disorder
• Emotional Disorder
• Mental Disorders
• Mood Disorders
• Neurodevelopmental Disorders
• Parenting

Intervention

Behavioral:
• Emotion Detectives: Unified protocol for transdiagnostic treatment of emotional disorders in children (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.

Other:
• ABC of Emotions
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).

Locations

Country	Name	City	State
Portugal	Faculty of Psychology and Education Sciences, University of Coimbra	Coimbra	Coimbra, Portugal

Sponsors (3)

Lead Sponsor	Collaborator
University of Coimbra	Centro Hospitalar Tondela-Viseu, Fundação para a Ciência e a Tecnologia

Country where clinical trial is conducted

Portugal, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility of the program by adherence and dropout rate	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).	Póst-treatment (15 weeks)
Other	Acceptability of the program	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).	Póst-treatment (15 weeks)
Primary	Changes of children's anxiety and depression		Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Primary	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.	Baseline, Póst treatment (15 weeks)
Secondary	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.	Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Secondary	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.	Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Secondary	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.	Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Secondary	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.	Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Secondary	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.	Baseline, Póst-treatment (15 weeks)
Secondary	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.	Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Secondary	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.	Baseline, Mid-treatment (7 weeks), Póst treatment (15 weeks), Follow-up 3 months
Secondary	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.	Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Secondary	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.	Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Secondary	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.	Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Secondary	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.	Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks)
Secondary	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.	Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Secondary	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.	Baseline, Póst-treatment (15 weeks)
Secondary	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.	Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Secondary	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.	Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Secondary	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.	Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Secondary	Changes of mindfulness in parenting	Measured by Interpersonal Mindfulness in Parenting Scale (IMP). Higher scores are indicative of higher levels of mindfulness in parenting.	Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

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