Internet Delivered ERITA for Nonsuicidal Self-Injury
Condition: Nonsuicidal Self-injury
MeSH terms: Wounds and Injuries; Self-Injurious Behavior
Study type: Interventional

Summary: 
      To evaluate if Internet delivered emotion regulation individual therapy for adolescents is an
      efficacious treatment when delivered as adjunctive to treatment as usual compared to a
      control group consisting of treatment as usual.
    

Detailed description: 
      Statistical Analyses

      Treatment effects will be evaluated according to the intention-to-treat principle. Primary
      end-point for all outcomes is post-treatment. Secondary end-point include a controlled 3
      month follow-up.

      Primary Analysis

      The primary outcome analysis will include treatment group (ERITA , TAU) and weekly reports of
      NSSI frequency measured once every week 4 weeks prior to treatment start, once every week
      during treatment, and once every week four weeks after treatment termination. Regression
      analysis modelled for count data will be used to estimate trend over time. Four weeks after
      treatment termination will be considered primary endpoint. Pairwise contrasts (group x time
      interaction) from the regression model will be used to evaluate between-group differences at
      primary endpoint (4 weeks after treatment termination).

      Secondary Analyses

      Secondary outcomes measured once before, during, and after treatment will be analyzed in a
      similar fashion as for the primary outcome, modelled after data's distribution (count or
      continuous). Measures collected only once at baseline and post-treatment will be analyzed
      with regression analyses including treatment group (online ERITA , TAU) as the
      between-subjects factor, time (baseline to post) as the within-subjects factor, and group ×
      time interactions, modelled after data's distribution (count or continuous).

      Parallel process latent growth curve modeling will be used to determine whether change in
      week-to-week emotion dysregulation (DERS-16) during treatment mediate the overall effect of
      ERITA+ETAU on week-to-week change in the primary outcome self-rated NSSI frequency (DSHI-Y).

      3 Month Follow-Up

      Data collected at 3-month follow-up will be used to determine the extent to which potential
      treatment gains were maintained both within and between treatment conditions

      Update 28 April 2022: As a secondary analyses, we also aim to investigate the effect of
      treatment moderators (primary aim) and predictors (secondary aim) on NSSI frequency one month
      after treatment termination. This update was submitted prior to conducting the analyses.

      The selection of potential moderators was theoretically and empirically motivated. We will
      investigate the following variables (measured at baseline):

      Age Difficulties in emotion regulation As measured with the Difficulties in Emotion
      Regulation Scale - 36 item version (DERS) Past month NSSI frequency As measured with the
      Deliberate Self-Harm Inventory Youth version (DSHI-Y) Global functioning As measured with the
      Childrens Global Assessment Scale Depressive symptoms As measured with the 21-item Depression
      Anxiety Stress Scales (DASS-21) Sleep difficulties As measured with the Insomnia Severity
      Index (ISI) Parental Minimization - discounting or devaluing the child's negative
      emotions/problems As measured with The Coping with Children's Negative Emotions Scale
      Adolescent Version (CCNES-A), subscale minimazation Level of suicidality As measured with the
      MINI-KID International Neuropsychiatric Interview, version 6
    

Intervention name(s): Emotion regulation individual therapy; Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The emotion regulation individual therapy is delivered via an internet platform and includes therapist contact several times per week via the platform.; Treatment as usual as provided in the community.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: NSSI