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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