SMART treatment for youth with complex trauma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares SMART, a sensory-motor approach using specialized equipment to aid regulation, to treatment as usual for youths with developmental trauma and self-regulation difficulties. It aims to see if SMART improves emotional and bodily regulation, attention and behavior, and trauma-related symptoms at 6 and 12 months. The study also explores whether the quality of the therapeutic relationship influences outcomes and whether differences in response vary across patients. About 120 children and adolescents from four CAMH units in Norway are randomized to SMART or TAU, with a focus on real-world applicability and potential systemic adoption if effective.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Roar Fosse, Ph.D. — Vestre Viken Hospital Trust
• Study coordinator: Roar Fosse, Ph.D.
• Email: roar.fosse@vestreviken.no
• Phone: +47 95008051

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.