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
Verified date | June 2019 |
Source | University of Cyprus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Cyprus | University of Cyprus | Nicosia |
Lead Sponsor | Collaborator |
---|---|
University of Cyprus |
Cyprus,
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
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) |
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