Unified Protocol for Children: A Randomized Controlled Trial for the Portuguese Population
- Conditions
- Mood DisordersEmotional DisorderEmotional; Disorder, Childhood, With Anxiety and FearfulnessAnxiety DisordersChild Mental DisorderParenting
- Interventions
- Other: ABC of Emotions
- Registration Number
- NCT04932421
- Lead Sponsor
- University of Coimbra
- 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:
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- Children aged 6-13
- Primary diagnosis of an anxiety and/or depression disorder
- Speaking, reading and understanding Portuguese
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group (ABC of emotions intervention) ABC of Emotions ABC of emotions - a psychoeducational intervention 5 sessions every 3 weeks for children
- Primary Outcome Measures
Name Time Method Changes of children's anxiety and depression Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months Changes of children's severity of psychopathology and improvement Baseline, Póst treatment (15 weeks) 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
Name Time Method Changes of child anxiety life interference Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months 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 behavioral avoidance Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months 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 emotionality Baseline, Póst-treatment (15 weeks) 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 Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months Measured by Children's Anxiety Sensitivity Inventory-Revised (CASI-R). Higher scores are indicative of higher levels of anxiety sensitivity.
Changes of children's mindfulness skills Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months 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 psychological flexibility Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months 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 tolerance of negative emotions Baseline, Mid-treatment (7 weeks), Póst treatment (15 weeks), Follow-up 3 months Measured by Distress Tolerance Scale (DTS). Higher scores are indicative of lower levels of tolerance to feel negative emotions.
Changes of children's emotional expression and emotion awareness Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months 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 Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks) 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 Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months 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 Baseline, Póst-treatment (15 weeks) 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 criticism Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months 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 children's negative affect Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months 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 cognitive error Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months 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 shaping of negative emotions Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months 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 Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months Measured by Interpersonal Mindfulness in Parenting Scale (IMP). Higher scores are indicative of higher levels of mindfulness in parenting.
Changes of parental inconsistency and permissiveness Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months 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.
Trial Locations
- Locations (1)
Faculty of Psychology and Education Sciences, University of Coimbra
🇵🇹Coimbra, Coimbra, Portugal, Portugal