Emotion Regulation Training for Adolescents With ADHD

NCT05664698 | Unknown

• 1 other identifier: ER_Isaksson
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this single-case study is to pilot and evaluate a new psychological intervention (SKILLS-ER) targeting emotion regulation in adolescents with ADHD. Participants (n=9; 13-18 years of age) and their parents will partake in the intervention consisting of a total of eight sessions.

Conditions

Attention Deficit Disorder With Hyperactivity; Emotion Regulation; ADHD

Outcome Measures

Primary Outcomes (3)

• Changes in self-ratings across baseline, intervention, post-intervention with Difficulties in Emotion Regulation Scale Short Form (DERS-SF)

  Brief version of the Difficulties in Emotion Regulation Scale, consisting of 18 items. Main outcomes include the total summed score of the DERS-SF, as well as the summed scores of individual subscales of the DERS-SF (six in total). Items are rated on a scale of 1 (= almost never) to 5 (= almost always). Items for the emotional awareness subscale are reverse-scored. Higher scores indicate higher levels of emotion regulation difficulties.

  Changes in DERS-SF will be investigated with weekly ratings (i.e., one time per week): before (during 5, 6 or 7 weeks depending on length of baseline), during the intervention (8 ratings during 8 weeks) and after (2 ratings during 2 weeks) SKILLS-ER

• Changes in parent-ratings across baseline, intervention, post-intervention with Difficulties in Emotion Regulation Scale Short Form (DERS-SF)

  Brief version of the Difficulties in Emotion Regulation Scale, consisting of 18 items. Main outcomes include the total summed score of the DERS-SF, as well as the summed scores of individual subscales of the DERS-SF (six in total). Items are rated on a scale of 1 (= almost never) to 5 (= almost always). Items for the emotional awareness subscale are reverse-scored. Higher scores indicate higher levels of emotion regulation difficulties.

  Changes in DERS-SF will be investigated with weekly ratings (i.e., one time per week): before (during 5, 6 or 7 weeks depending on length of baseline), during the intervention (8 ratings during 8 weeks) and after (2 ratings during 2 weeks) SKILLS-ER

• Changes in parental rated Target behaviors (individually defined) across baseline, intervention and post-intervention

  Individually defined target behaviors associated with emotion regulation which are rated in frequency.

  Changes in target behaviors will be investigated with daily ratings: before (1 time per day during 5, 6 or 7 days before first week of intervention phase), during the intervention (1 time per day during 8 weeks) and after (daily during 2 weeks) SKILLS-ER

Secondary Outcomes (12)

• Changes in self-ratings with Cognitive Emotion Regulation Questionnaire from baseline to post-intervention

  Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER

• Changes in self-ratings regarding functional impairment from baseline to post-intervention

  Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER

• Changes in parent-ratings regarding functional impairment from baseline to post-intervention

  Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER

• Changes in self-ratings with Adult ADHD Self-Report Scale Adolescent version (ASRS-A) from baseline to post-intervention

  Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER

• Changes in parent-ratings with Adult ADHD Self-Report Scale Adolescent version (ASRS-A) from baseline to post-intervention

  Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER

Other Outcomes (1)

• Adherence to treatment programme (ratings by therapists)

  During intervention phase (directly after each session)

Study Arms (1)

SKILLS-ER

EXPERIMENTAL

Emotion regulation training

Behavioral: SKILLS-ER

Interventions

SKILLS-ER BEHAVIORAL

The intervention (SKILLS-ER) has been developed by the research group, and aims to increase a participant's emotion regulation capacity by targeting different stages of the emotion regulation process proposed by the extended process model of emotion, i.e. identification, selection, implementation and monitoring (Sheppes, Suri \& Gross, 2015). SKILLS-ER will comprise of eight sessions and include identification and differentiation of emotions, tolerance/acceptance of emotions, education of different regulatory skills, as well as on how to select, implement and monitor strategies. Sessions will take place at the Uppsala child- and adolescent psychiatry outpatient unit and consist of activating and experiential exercises administered by a clinical psychologist. Participants will gain access to internet-delivered material, such as homework assignments in-between sessions. SKILLS-ER will be delivered individually to the participants, where their parents will be involved in some sessions.

SKILLS-ER

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ADHD diagnosis
• Self- and/or parent-rated emotion regulation difficulties, as indicated via the Emotion Questionnaire (EQ).

You may not qualify if:

• Intellectual disability
• Autism
• Psychosis
• Bipolar disorder
• Severe depression
• Non-stabilized medication for ADHD at intake (if on medication for ADHD)
• Other ongoing psychological treatment

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala University

Uppsala, Sweden

RECRUITING

Related Publications (1)

• Sheppes G, Suri G, Gross JJ. Emotion regulation and psychopathology. Annu Rev Clin Psychol. 2015;11:379-405. doi: 10.1146/annurev-clinpsy-032814-112739. Epub 2015 Jan 2.

  PMID: 25581242 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Emotional Regulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Johan Isaksson, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Isaksson, PhD

CONTACT

+46 018 6112540; johan.isaksson@neuro.uu.se

Rebecka Astenvald, MSc

CONTACT

rebecka.astenvald@neuro.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One intervention (emotion regulation training) with three randomized pre-intervention baselines at different lengths.

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 27, 2022
• Study Start: January 24, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)