Clinical Research Directory

Effect Study of SMART Treatment for Youth

Sponsor: Vestre Viken Hospital Trust

Summary

The goal of this clinical trial is to learn if Sensory motor arousal regulation treatment (SMART) works better than treatment as usual (TAU) to treat youth 7-17 years with complex trauma histories and self-regulation difficulties. The study also will investigate which patients will benefit more from SMART (treatment effect heterogeneity) and whether therapeutic alliance mediates effect. The main hypotheses the trial aims to answer are: 1. Main effects: The SMART model approach will be more effective than ordinary treatment (control condition), in terms of improvement from therapy starts to 6 and 12 months follow up, for: 1. Regulatory capacities of emotions and bodily states, attention and behavior, and self and social relations 2. Trauma symptoms of re-experiencing, avoidance/ numbness and hyperarousal and sense of threat (core PTSD symptoms) and disturbances in self-organization (affect, self-concept; relations - core complex PTSD symptoms) 3. Internalizing symptoms (somatic complaints, anxiety symptoms and depression symptom severity) and Externalizing symptoms (conduct problems, aggression, inattention, and social problem severity) 4. Psychosocial strengths - prosocial behavior, subjective well-being and impairment in peer relationships, family relationships, and academic/school functioning 2. Exploration of mediation: When comparing SMART and ordinary treatment (TAU), (i) therapeutic alliance is higher in SMART, and (ii) a better treatment effect in SMART is partially mediated by therapeutic alliance 3\. Exploration of treatment effect heterogeneity (moderators): Effects of SMART treatment compared to TAU vary between: patients with low versus high level of self-regulation difficulties (full vs partial Developmental trauma disorder), patients with extensive vs less extensive developmental trauma exposure, adolescents (13-17 years) vs younger children (7-12 years), and patients exposed to trauma early in life vs in their teens At each site, eligible participants are randomized to SMART or ordinary treatment/ TAU. Investigators acquire study data at baseline and outcome data at follow up after 6 and 12 months, and measure therapeutic alliance twice during the treatment process.

Official title: A Randomized Controlled Evaluation of Sensory Motor Arousal Regulation Treatment (SMART) for Youth With Developmental Trauma and Self-regulation Difficulties

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