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Emotion Regulation Training for Adolescents With ADHD

Not Applicable
Recruiting
Conditions
ADHD
Attention Deficit Disorder With Hyperactivity
Emotion Regulation
Interventions
Behavioral: SKILLS-ER
Registration Number
NCT05664698
Lead Sponsor
Uppsala University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
6
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
SKILLS-ERSKILLS-EREmotion regulation training
Primary Outcome Measures
NameTimeMethod
Changes in self-ratings across baseline, intervention, post-intervention with Difficulties in Emotion Regulation Scale Short Form (DERS-SF)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

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-interventionChanges 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

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

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

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.

Secondary Outcome Measures
NameTimeMethod
Changes in parent-ratings regarding functional impairment from baseline to post-interventionComparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER

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

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 Cognitive Emotion Regulation Questionnaire from baseline to post-interventionComparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER

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 with Spence Children's Anxiety Scale Short version (SCAS-S) from baseline to post-interventionComparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER

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 SNAP-IV from baseline to post-interventionComparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER

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)Rated at 1 time-point directly after completing the last SKILLS-ER session

Negative Effects Questionnaire. Consists of 20 items. A higher score indicates more negative effects.

Self-rated Client satisfactionRated at 1 time-point directly after completing the last SKILLS-ER session

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 satisfactionRated at 1 time-point directly after completing the last SKILLS-ER session

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.

Changes in self-ratings regarding functional impairment from baseline to post-interventionComparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER

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 with Adult ADHD Self-Report Scale Adolescent version (ASRS-A) from baseline to post-interventionComparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER

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 Spence Children's Anxiety Scale (SCAS) from baseline to post-interventionComparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER

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.

Parent-ratings with Negative Effects Questionnaire (NEQ)Rated at 1 time-point directly after completing the last SKILLS-ER session

Negative Effects Questionnaire. Consists of 20 items. A higher score indicates more negative effects.

Trial Locations

Locations (1)

Uppsala University

🇸🇪

Uppsala, Sweden

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