Enhancement of Emotion Regulation Skills in Adolescents

Behavior Problem Clinical Trial

Official title:

Enhancement of Emotion Regulation Skills in Vulnerable Adolescents at Risk for Addictions and Psychopathology Due to Risk Factors in the Family

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04001140
• Other study ID #: UCyprus
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: May 15, 2020

Study information

• Verified date: June 2019
• Source: University of Cyprus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For the current study, a prevention program is developed and applied to enhance the emotion regulation skills of adolescents. Before and after the application of the prevention program, all participants will be assessed for their emotion regulation ability via questionnaires and a physiological examination in which heart rate and skin conductance will be measured.

Description:

The purpose of this research is to assess whether a short-term group intervention can enhance the emotion regulation skills of adolescents, when the family environment experiences stressful situations, psychopathology or substance abuse. This study aims to increase intervention effectiveness by examining effective approaches to train a crucial mechanism involved in emotional and behavior problems, which is emotion regulation. This research aims to develop a prevention program focused on the enhancement of adolescents' emotion regulation. Before and after the prevention program, participants will answer questionnaires and do a 5 minute psychophysiology experiment to evaluate their emotion regulation ability with both subjective and objective approaches. This prevention program, which is short-term, entailing 7 sessions, synthesizes techniques from three therapeutic models: Cognitive-Behavioral Therapy, Dialectical-Behavioral Therapy and Acceptance and Commitment Therapy. A short-term intervention was formulated and will be tested in the current study, with which is considered an advancement from previous similar interventions because of this synthesis and specific focus on emotion regulation skills, the lack of which can be considered a transdiagnostic risk factor across many psychological conditions and outcomes, including substance use. The main purpose is to help adolescents to enhance their emotion regulation, with the ultimate goal to decrease their risk of developing addictions and other psychopathology.

According to some classic theories of emotion, each emotion triggers a discrete pattern of behaviour, physiology, thoughts and feelings (Mauss & Robinson, 2009; Russell, 2003). This research will assess adolescents' emotion regulation through three dimensions: a) self-reported emotion reactivity (e.g. sensitivity, arousal/intensity and persistence), b) self-reported emotion regulation (e.g. self-blame, other-blame, rumination, catastrophizing, putting into perspective, positive refocusing, positive reappraisal, acceptance, planning, impulsivity, awareness and emotional clarity) and c) physiological (heart rate and skin conductance). These three dimensions will be assessed before and after the prevention program using relevant questionnaires and an experiment. The prevention program will focus on the enhancement of emotion regulation. However, it is expected that differences in the other two dimensions will also be found parallel to enhancement of emotion regulation skills.

Regarding the randomized control trial study, half of participants will take part in the intervention group and the other half in the waiting-list group. Participants will be divided into groups; each group of 5-10 adolescents (mixed male and female). Participants in the waiting-list group will receive the intervention when the intervention group finish the intervention. The questionnaires will be answered by all participants before and after the intervention and by those in the waiting list group. All participants will answer the questionnaires before and after a five week time interval during which the intervention will take place for the intervention group.

Physiological assessment of emotion processing will be of a 5 minutes duration, during an emotional imagery task, and participants participate twice -before and after the intervention for the intervention group, and two times with 5 weeks in between for the waiting-list group. The experiment will begin after a rest period which includes relaxation in the absence of any stimuli for 2 minutes (baseline) during which heart rate (HR) and skin conductance (SC) will be measured. Afterwards, participants will be asked to imagine six pre-standardized emotional scenarios, which three of them focusing on anger and three on fear situations, appropriate for their age. Participants will be given specific instructions on how to regulate their emotional responses to each scenario. Participants are given written instructions as to how they are to regulate elicited emotions during the different scenarios. Three different sets of emotion regulation instructions will be given to all participants: no guidance, acceptance and cognitive reappraisal. Participants will memorize each scenario prior to engaging in imagery and have to recall the scene as vividly as possible when each trial begins as prompted by the researcher. The duration of each imagery trial for each scenario is 30 seconds. Physiological measurements will be recorded during each scenario. More specifically, heart rate and skin conductance will be measured. Once this pre-intervention assessment is completed, the 7 sessions of group intervention will follow. In addition, at the end of each session participants will set a goal relevant to the skills which they have just learnt to practice at home as homework. For example, if the content of the session is the anger management, participants goal will be to start recognize their emotions and try to calm using different ways, and then when they are ready to express their emotions and try to find a functional solution.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion criteria:

• Adolescents who have a family member with addiction problems (drug or alcohol use, gambling)

• Adolescents who have a family member with psychological problems (e.g. depression, anxiety disorder, bipolar disorder, etc.)

• Adolescents from stressful family environments (domestic violence, maltreatment, divorce, mourning, etc.)

• Participants are literate in Greek.

Exclusion criteria:

• Adolescents with severe addiction problems themselves (daily or weekly drugs use, such as cocaine, heroin, crystal meth, etc.)

• Adolescents with severe psychopathology (e.g. bipolar disorder, schizophrenia)

• Participants who are not literate in Greek.

Related Conditions & MeSH terms

• Behavior Problem
• Emotional Problem
• Problem Behavior

Intervention

Behavioral:
• Enhancement of emotion regulation skills
Regarding the intervention, 7 sessions will be carried out. The main purpose is to help adolescents to enhance their emotion regulation, with the ultimate goal to decrease their risk of developing addictions and other psychopathology.

Locations

Country	Name	City	State
Cyprus	University of Cyprus	Nicosia

Sponsors (1)

Lead Sponsor	Collaborator
University of Cyprus

Country where clinical trial is conducted

Cyprus, 

References & Publications (13)

Feldman-Barrett L, Gross JJ, Christensen TC, Benvenuto M. Knowing what you're feeling and knowing what to do about it: mapping the relation between emotion differentiation and emotion regulation. Cognition and Emotion 15: 713-724, 2001.

Goldin PR, Moodie CA, Gross JJ. Acceptance versus reappraisal: Behavioral, autonomic, and neural effects. Cogn Affect Behav Neurosci. 2019 Aug;19(4):927-944. doi: 10.3758/s13415-019-00690-7. — View Citation

Gratz KL, Roemer L. Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment 26: 41-54, 2004.

Gross JJ. Emotion regulation: affective, cognitive, and social consequences. Psychophysiology. 2002 May;39(3):281-91. Review. — View Citation

Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. — View Citation

Leahy RL. A model of emotional schemas. Cognitive and Behavioral Practice 9: 177-190, 2002.

Marchesi C, Fontò S, Balista C, Cimmino C, Maggini C. Relationship between alexithymia and panic disorder: a longitudinal study to answer an open question. Psychother Psychosom. 2005;74(1):56-60. — View Citation

Milyavsky M, Webber D, Fernandez JR, Kruglanski AW, Goldenberg A, Suri G, Gross JJ. To reappraise or not to reappraise? Emotion regulation choice and cognitive energetics. Emotion. 2019 Sep;19(6):964-981. doi: 10.1037/emo0000498. Epub 2018 Sep 20. — View Citation

Salovey P, Mayer JD, Goldman SL, Turvey C, Palfai TP. Emotional attention, clarity, and repair: exploring emotional intelligence using the trait meta-mood scale. In JW Pennebaker (Ed.), Emotion, disclosure, and health (pp. 125-154). Washington, DC: American Psychological Association, 1995.

Sloan DM, Kring AM. Measuring changes in emotion during psychotherapy: conceptual and methodological issues. Clinical Psychology: Science and Practice 14: 307-322, 2007.

Smith EN, Romero C, Donovan B, Herter R, Paunesku D, Cohen GL, Dweck CS, Gross JJ. Emotion theories and adolescent well-being: Results of an online intervention. Emotion. 2018 Sep;18(6):781-788. doi: 10.1037/emo0000379. Epub 2017 Dec 21. — View Citation

Southam-Gerow MA. Emotion regulation in children and adolescents. New York: the Guilford Press, 2013.

Thompson RJ, Dizén M, Berenbaum H. The Unique Relations between Emotional Awareness and Facets of Affective Instability. J Res Pers. 2009 Oct 1;43(5):875-879. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in difficulties of emotion regulation	Self-reported measures for adolescents' emotion regulation skills: Difficulties in Emotion Regulation Scale (Gratz & Roemer, 2004). It is a brief, 36-item self-report questionnaire designed to assess multiple aspects of emotional dysregulation. Each item is rated on a 1 to 5 scale (1 =almost never and 4 = almost always). Higher scores suggest greater problems with emotion regulation. This questionnaire assesses six sub-scales: acceptance, goals, impulsivity, awareness, strategies and clarity.	Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Primary	Changes in enhancement of emotion regulation skills	Self-reported measures for adolescents' emotion regulation: Cognitive Emotion Regulation Questionnaire (Garnefski, Kraaij, & Spinhoven, 2002). It is a 36-item questionnaire, consisting of 9 conceptually distinct subscales (Self-blame, Other-blame, Rumination, Catastrophizing, Putting into Perspective, Positive Refocusing, Positive Reappraisal, Acceptance and Planning). Each item is rated on a 1 to 5 scale (1 =almost never and 4 = almost always). Individual subscale scores are obtained by summing up the scores belonging to the particular subscale (ranging from 4 to 20). The higher the subscale score, the more a specific cognitive strategy is used.	Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Primary	Changes in heart rate	Experiment: measured through heart rate	Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Primary	Psychophysiological changes in skin conductance	Experiment: measured through skin conductance	Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Secondary	Depression symptoms	Changes in the self-reported measure Youth Self-Report sub-scores of depression symptoms. This screening tool contains 13 questions to assess the depression symptoms, which are scored using a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). Higher scores suggest greater emotional problems.	Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Secondary	Anxiety symptoms	Changes in the self-reported measure Youth Self-Report sub-scores of anxiety symptoms. This screening tool contains 6 questions to assess the anxiety symptoms, which are scored using a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). Higher scores suggest greater anxiety problems.	Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Secondary	Aggression problems	Changes in the self-reported measure Youth Self-Report sub-scores of conduct disorder. This tool contains 15 questions to assess the conduct disorder, which are scored using a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). Higher scores suggest greater conduct problems.	Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Secondary	Attention-Deficit/Hyperactivity Disorder symptoms	Changes in the self-reported measure Youth Self-Report sub-scores of attention deficit/ hyperactivity disorder. This tool contains 7 questions to assess the attention deficit/ hyperactivity disorder, which are scored using a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). Higher scores suggest greater problems with attention deficit/ hyperactivity disorder.	Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Secondary	Change in Nicotine Dependence	Change in the Fagerstrom Test of Nicotine Dependence averaged scores. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use and dependence. Higher scores suggest nicotine dependence.	Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)
Secondary	Change in alcohol consumption	Change in the Alcohol Use Disorders Identification Test averaged scores	Pre-Intervention (day 1), Post-Intervention (7 weeks after the pre-intervention), follow-up (6 months after the post-intervention)