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Emotion Regulation Training for Adolescents With ADHD

Primary Purpose

Attention Deficit Disorder With Hyperactivity, Emotion Regulation, ADHD

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
SKILLS-ER
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ADHD diagnosis Self- and/or parent-rated emotion regulation difficulties, as indicated via the Emotion Questionnaire (EQ). Exclusion Criteria: Intellectual disability Autism Psychosis Bipolar disorder Severe depression Non-stabilized medication for ADHD at intake (if on medication for ADHD) Other ongoing psychological treatment

Sites / Locations

  • Uppsala UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SKILLS-ER

Arm Description

Emotion regulation training

Outcomes

Primary Outcome Measures

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 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 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.

Secondary Outcome Measures

Changes in self-ratings with Cognitive Emotion Regulation Questionnaire from baseline to post-intervention
Cognitive Emotion Regulation Questionnaire (rated by participants only), which aims to measure different cognitive emotion regulation strategies (nine in total) and consists of 18 items. Items are rated on a scale from 1 (= almost never) to 5 (= almost always). Items belonging to a particular strategy are summed together, where higher scores indicate more usage of that specific strategy.
Changes in self-ratings regarding functional impairment from baseline to post-intervention
Questionnaire on functional impairment in every-day life. Scored with 4 items on a 5-point Likert scale with higher score indicating more functional impairment.
Changes in parent-ratings regarding functional impairment from baseline to post-intervention
Questionnaire on functional impairment in every-day life. Scored with 4 items on a 5-point Likert scale with higher score indicating more functional impairment.
Changes in self-ratings with Adult ADHD Self-Report Scale Adolescent version (ASRS-A) from baseline to post-intervention
Adult ADHD Self-Report Scale Adolescent version, consisting of 18 items in total. Items are rated on a scale from 0 (=never) to 4 (=very often). Items are summed together where higher scores indicate more ADHD symptoms.
Changes in parent-ratings with Adult ADHD Self-Report Scale Adolescent version (ASRS-A) from baseline to post-intervention
Adult ADHD Self-Report Scale Adolescent version, consisting of 18 items in total. Items are rated on a scale from 0 (= never) to 4 (= very often). Items are summed together, where higher scores indicate more ADHD symptoms.
Changes in self-ratings with Spence Children's Anxiety Scale Short version (SCAS-S) from baseline to post-intervention
Spence Children's Anxiety Scale Short version (SCAS-S), consisting of 19 items in total. Items are rated on a scale from 0 (= never) to 3 (= always). The total score is the sum of all the items, where higher scores indicate more anxiety symptoms.
Changes in parent-ratings with Spence Children's Anxiety Scale (SCAS) from baseline to post-intervention
Spence Children's Anxiety Scale. Items are rated on a scale from 0 (= never) to 3 (= always). The total score is the sum of all the 39 items, where higher scores indicate more anxiety symptoms.
Changes in parent-ratings with SNAP-IV from baseline to post-intervention
The sum of the eight items on the SNAP-IV scale that measures symptoms of oppositional defiant disorder (rated by parents only). Items are rated on a scale from 0 (= not at all) to 3 (= very much), with a higher score indication more symptoms.
Self-ratings with Negative Effects Questionnaire (NEQ)
Negative Effects Questionnaire. Consists of 20 items. A higher score indicates more negative effects.
Parent-ratings with Negative Effects Questionnaire (NEQ)
Negative Effects Questionnaire. Consists of 20 items. A higher score indicates more negative effects.
Self-rated Client satisfaction
Items on client satisfaction. In total 8 questions. On 4 of these questions, items are rated on a 4-point Likert scale where higher score indicated a higher satisfaction with the intervention.
Parent-rated Client satisfaction
Items on client satisfaction. In total 8 questions. On 4 of these questions, items are rated on a 4-point Likert scale where higher score indicated a higher satisfaction with the intervention.

Full Information

First Posted
November 24, 2022
Last Updated
June 19, 2023
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT05664698
Brief Title
Emotion Regulation Training for Adolescents With ADHD
Official Title
Emotion Regulation Training for Adolescents With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Attention-Deficit/Hyperactivity Disorder (ADHD) results in functional impairment across several life domains and is associated with high comorbidity rates and negative long-term outcomes. For adolescents with ADHD, emotional dysregulation constitute an increasing health problem. The ability to regulate one's emotions has been suggested as a major candidate for transdiagnostic sources of risk and/or resilience. A sample of adolescents (n=9; 13-18 years of age) with ADHD and emotion dysregulation will participate in an emotion regulation intervention (SKILLS-ER) in order to evaluate feasibility, potential effectiveness and to detect mechanisms that could strengthen adaptive regulation skills. The emotion regulation programme will include eight weekly sessions, and although primarily directed towards the adolescent, parents will be invited and participate in some sessions. The researchers will apply a single-case multiple baseline design across participants with repeated measurements and pre-intervention baselines at different lengths (5, 6 and 7 weeks) to which participants are randomized. The researchers will analyze the data with a combination of visual and quantitative analyses, see study protocol and statistical analysis plan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity, Emotion Regulation, ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One intervention (emotion regulation training) with three randomized pre-intervention baselines at different lengths.
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SKILLS-ER
Arm Type
Experimental
Arm Description
Emotion regulation training
Intervention Type
Behavioral
Intervention Name(s)
SKILLS-ER
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in self-ratings across baseline, intervention, post-intervention with Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
Description
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.
Time Frame
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
Title
Changes in parent-ratings across baseline, intervention, post-intervention with Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
Description
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.
Time Frame
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
Title
Changes in parental rated Target behaviors (individually defined) across baseline, intervention and post-intervention
Description
Individually defined target behaviors associated with emotion regulation which are rated in frequency.
Time Frame
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 Outcome Measure Information:
Title
Changes in self-ratings with Cognitive Emotion Regulation Questionnaire from baseline to post-intervention
Description
Cognitive Emotion Regulation Questionnaire (rated by participants only), which aims to measure different cognitive emotion regulation strategies (nine in total) and consists of 18 items. Items are rated on a scale from 1 (= almost never) to 5 (= almost always). Items belonging to a particular strategy are summed together, where higher scores indicate more usage of that specific strategy.
Time Frame
Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
Title
Changes in self-ratings regarding functional impairment from baseline to post-intervention
Description
Questionnaire on functional impairment in every-day life. Scored with 4 items on a 5-point Likert scale with higher score indicating more functional impairment.
Time Frame
Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
Title
Changes in parent-ratings regarding functional impairment from baseline to post-intervention
Description
Questionnaire on functional impairment in every-day life. Scored with 4 items on a 5-point Likert scale with higher score indicating more functional impairment.
Time Frame
Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
Title
Changes in self-ratings with Adult ADHD Self-Report Scale Adolescent version (ASRS-A) from baseline to post-intervention
Description
Adult ADHD Self-Report Scale Adolescent version, consisting of 18 items in total. Items are rated on a scale from 0 (=never) to 4 (=very often). Items are summed together where higher scores indicate more ADHD symptoms.
Time Frame
Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
Title
Changes in parent-ratings with Adult ADHD Self-Report Scale Adolescent version (ASRS-A) from baseline to post-intervention
Description
Adult ADHD Self-Report Scale Adolescent version, consisting of 18 items in total. Items are rated on a scale from 0 (= never) to 4 (= very often). Items are summed together, where higher scores indicate more ADHD symptoms.
Time Frame
Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
Title
Changes in self-ratings with Spence Children's Anxiety Scale Short version (SCAS-S) from baseline to post-intervention
Description
Spence Children's Anxiety Scale Short version (SCAS-S), consisting of 19 items in total. Items are rated on a scale from 0 (= never) to 3 (= always). The total score is the sum of all the items, where higher scores indicate more anxiety symptoms.
Time Frame
Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
Title
Changes in parent-ratings with Spence Children's Anxiety Scale (SCAS) from baseline to post-intervention
Description
Spence Children's Anxiety Scale. Items are rated on a scale from 0 (= never) to 3 (= always). The total score is the sum of all the 39 items, where higher scores indicate more anxiety symptoms.
Time Frame
Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
Title
Changes in parent-ratings with SNAP-IV from baseline to post-intervention
Description
The sum of the eight items on the SNAP-IV scale that measures symptoms of oppositional defiant disorder (rated by parents only). Items are rated on a scale from 0 (= not at all) to 3 (= very much), with a higher score indication more symptoms.
Time Frame
Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
Title
Self-ratings with Negative Effects Questionnaire (NEQ)
Description
Negative Effects Questionnaire. Consists of 20 items. A higher score indicates more negative effects.
Time Frame
Rated at 1 time-point directly after completing the last SKILLS-ER session
Title
Parent-ratings with Negative Effects Questionnaire (NEQ)
Description
Negative Effects Questionnaire. Consists of 20 items. A higher score indicates more negative effects.
Time Frame
Rated at 1 time-point directly after completing the last SKILLS-ER session
Title
Self-rated Client satisfaction
Description
Items on client satisfaction. In total 8 questions. On 4 of these questions, items are rated on a 4-point Likert scale where higher score indicated a higher satisfaction with the intervention.
Time Frame
Rated at 1 time-point directly after completing the last SKILLS-ER session
Title
Parent-rated Client satisfaction
Description
Items on client satisfaction. In total 8 questions. On 4 of these questions, items are rated on a 4-point Likert scale where higher score indicated a higher satisfaction with the intervention.
Time Frame
Rated at 1 time-point directly after completing the last SKILLS-ER session
Other Pre-specified Outcome Measures:
Title
Adherence to treatment programme (ratings by therapists)
Description
Therapist adherence to the treatment programme will be measured by the therapist self-ratings for each session. Items are rated on a scale from 1 (=not completed) to 3 (=completed). A higher score indicate better adherence.
Time Frame
During intervention phase (directly after each session)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ADHD diagnosis Self- and/or parent-rated emotion regulation difficulties, as indicated via the Emotion Questionnaire (EQ). Exclusion Criteria: Intellectual disability Autism Psychosis Bipolar disorder Severe depression Non-stabilized medication for ADHD at intake (if on medication for ADHD) Other ongoing psychological treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johan Isaksson, PhD
Phone
+46 018 6112540
Email
johan.isaksson@neuro.uu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecka Astenvald, MSc
Email
rebecka.astenvald@neuro.uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Isaksson, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25581242
Citation
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.
Results Reference
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Emotion Regulation Training for Adolescents With ADHD

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