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)
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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