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Table 1 Outcomes of the TEENS feasibility trial

From: An Internet-based emotion regulation intervention versus no intervention for non-suicidal self-injury in adolescents: a statistical analysis plan for a feasibility randomised clinical trial

Outcomes Type of data
Feasibility outcomes
 Fraction of at least one completed clinical outcome (NSSI events) at end of the intervention Proportion
 Fraction of participants to include and randomise Proportion
 Fraction of compliance Proportion
Explorative primary clinical outcome
 Frequency of non-suicidal self-injury
Deliberate Self-Harm Inventory (DSHI-Y) [21]
Count; longitudinal
Explorative secondary clinical outcomes
 Quality of life
Kidscreen-10 [22]
Continuous; longitudinal
 Symptoms of depression
Depression Anxiety Stress Scale (DASS-21) [23]
Count; longitudinal
 Symptoms of anxiety
Depression Anxiety Stress Scale (DASS-21) [23]
Count; longitudinal
 Symptoms of stress
Depression Anxiety Stress Scale (DASS-21) [23]
Count; longitudinal
 Self-injury
Yes/no
Discrete; once
 Sick days
Proportion of sick days during the last month
Continuous; longitudinal
Further explorative clinical outcomes
 Difficulties in emotion regulation
Difficulties in Emotion Regulation Scale (DERS-16) [24]
Continuous; longitudinal
 Indirect self-destructive behaviours
Borderline Symptom List (BSL-supplement) + 1 item C-SSRS (ideations)
Count; longitudinal
 Suicidal ideations, plan, and actions
Columbia (C-SSRS) [25]
a
 Distress reactions—adolescent rated parents’ ability to cope with children’s negative emotions.
The Coping with Children’s Negative Emotions Scale (CCNES-APP) [26]
Continuous; once
 Punitive reactions—adolescent rated parents’ ability to cope with children’s negative emotions.
The Coping with Children’s Negative Emotions Scale (CCNES-APP) [26]
Continuous; once
 Expressive encouragement—adolescent rated parents’ ability to cope with children’s negative emotions.
The Coping with Children’s Negative Emotions Scale (CCNES-APP) [26]
Continuous; once
 Emotion-focused reactions—adolescent rated parents’ ability to cope with children’s negative emotions.
The Coping with Children’s Negative Emotions Scale (CCNES-APP) [26]
Continuous; once
 Problem-focused reactions—adolescent rated parents’ ability to cope with children’s negative emotions.
The Coping with Children’s Negative Emotions Scale (CCNES-APP) [26]
Continuous; once
 Minimization reactions—adolescent rated parents’ ability to cope with children’s negative emotions.
The Coping with Children’s Negative Emotions Scale (CCNES-APP) [26]
Continuous; once
 Adverse events
Negative Effects Questionnaire (NEQ) [27]
Continuous; once
  1. Longitudinal refers to the outcomes assessed at baseline and follow-up
  2. aC-SSRS will be analysed at a later time point, as no consensus on methodology has been identified