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Status:

NOT_YET_RECRUITING

Effect Study of SMART Treatment for Youth

Lead Sponsor:

Vestre Viken Hospital Trust

Conditions:

Stress Disorders, Traumatic

Psychological Trauma

Eligibility:

All Genders

7-17 years

Phase:

NA

Brief 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...

Detailed Description

Specialized mental health services often fall short in adequate treatment of youth with developmental trauma histories. These youth are often difficult to treat due to composite mental and somatic pro...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 25 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 31 2027

    Estimated Enrollment :

    120 Patients enrolled

    Trial Details

    Trial ID

    NCT07200713

    Start Date

    September 25 2025

    End Date

    December 31 2027

    Last Update

    October 1 2025

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Dpt of Child and Adolescent Mental Health (CAMH) Vestre Viken - Asker

    Asker, Akershus, Norway

    2

    Dpt of Child and Adolescent Mental Health (CAMH) Vestre Viken - Ringerike Ål

    Ål, Buskerud, Norway

    3

    Dpt of Child and Adolescent Mental Health (CAMH) Vestre Viken - Drammen

    Drammen, Buskerud, Norway

    4

    Dpt of Child and Adolescent Mental Health (CAMH) Vestre Viken - Kongsberg

    Kongsberg, Buskerud, Norway