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Effect Study of SMART Treatment for Youth

Sponsor: Vestre Viken Hospital Trust • ClinicalTrials.gov ID: NCT07200713

Registry updated: 2026-09-09

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Description

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.

Interventions

Treatment as usual (TAU) (Other)
Best practice ordinary psychological treatment
Sensory motor arousal regulation treatment (SMART) (Other)
Psychological treatment using SMART room and associated techniques

Eligibility criteria

Inclusion criteria: These are based on the Developmental Trauma Disorder Semistructured Interview (DTD-SI), which has four domains (A-D). Based on the DTD-SI, which is detailed below, inclusion requires: * The presence of developmental trauma history (domain A) * One symptom in each of the domains B-D * At least four symptoms (of a maximum 15) in domains B-D considered together Domains A to D above refers to the following: * Domain A. Lifetime contemporaneous exposure to developmental trauma, defined as either (i) Interpersonal victimization: physical or sexual abuse or assault, domestic/intimate partner violence, bullying, harassment, exploitation, trafficking, hate crimes, or racial/ethnic/identity trauma, or (ii) Primary caregiving system attachment disruption: caregiver change or prolonged separation, gross neglect (physical, medical, emotional), psychological maltreatment (emotional abuse, emotional neglect, parental hostility or over-controlling), caregiver impairment due to mental illness or substance abuse, or chronic medical condition (by child or caregiver) * Domain B. Affective and somatic dysregulation: (i) Emotion dysregulation, (ii) Somatic dysregulation, (iii) Impaired awareness or dissociation of emotions and body, (iv) Impaired capacity to describe emotions or bodily states * Domain C. Attentional and behavioral dysregulation: (i) Threat-related rumination, (ii) Impaired capacity for self protection, (iii) Maladaptive self-soothing, (iv) Habitual or reactive self-harm, (v) Inability to initiate or sustain goal-directed behavior * Domain D. Self and relational dysregulation: (i) Persistent extreme negative self-perception, (ii) attachment insecurity and disorganization, (iii) Extreme persistent distrust, defiance or lack of reciprocity in close relationships, (iv) Reactive physical or verbal aggression, (v) Psychological boundary deficits, (vi) Impaired capacity to regulate empathic arousal Exclusion Criteria: * Active psychosis * Not fluent in Norwegian language * Developmental challenges - IQ \< 70 * Has previously used SMART room

Conditions

Stress Disorders, Traumatic Psychological Trauma Sexual Trauma Stress Disorders, Post-Traumatic; Mental Disorders

Locations

Dpt of Child and Adolescent Mental Health (CAMH) Vestre Viken - Asker — Asker, Akershus, Norway
Dpt of Child and Adolescent Mental Health (CAMH) Vestre Viken - Ringerike Ål — Ål, Buskerud, Norway
Dpt of Child and Adolescent Mental Health (CAMH) Vestre Viken - Drammen — Drammen, Buskerud, Norway
Dpt of Child and Adolescent Mental Health (CAMH) Vestre Viken - Kongsberg — Kongsberg, Buskerud, Norway

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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