An interventional study of Treatment as usual (TAU) and Sensory motor arousal regulation treatment (SMART) in Stress Disorders, Traumatic, Psychological Trauma and Sexual Trauma, sponsored by Vestre Viken Hospital Trust. Recruiting at 4 sites in Norway. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Vestre Viken Hospital Trust · Not applicable, Interventional, and Treatment
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:
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:
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.
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 problems. A promising treatment model for the group is the SMART approach, which utilizes sensory motor therapeutic equipment in a specialized room to support youths' natural ways of regulating bodies and emotions. This may facilitate therapeutic bond, improve regulation of arousal, and facilitate a more effective processing of trauma. The study will test the effectiveness of SMART treatment for young people 7-17 years old with developmental trauma and self-regulation difficulties in a two-group RCT. The investigators hypothesize that the SMART approach is more effective than ordinary treatment for an array of outcome measures, including regulatory capacities, attention and behavior; trauma symptoms; and internalizing and externalizing symptoms. The study also will explore if therapeutic alliance mediates treatment effects and heterogeneity of treatment effects (moderator analyses). The study will include 120 children/ adolescents with developmental trauma exposure and difficulties in self-regulatory capacities from four units at dpt. of child and adolescent mental health, Vestre Viken, randomized to SMART or ordinary treatment. This first RCT of SMART for youth has the potential to test whether the model should be adopted as standard treatment for youth in the target group in Norway and internationally.
120 studies on the registry are indexed under Stress Disorders, Traumatic; 23 are open to participants now.
This study's planned enrollment of 120 is above the median of 67 across 97 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Vestre Viken Hospital Trust is the lead sponsor of 52 studies on the registry; 23 are open to participants now.
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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:
Domains A to D above refers to the following:
Exclusion Criteria:
Treatment using SMART rooms and associated SMART techniques
Other: Sensory motor arousal regulation treatment (SMART)
Best practice ordinary treatment without using SMART approaches
Other: Treatment as usual (TAU)
Best practice ordinary psychological treatment
Psychological treatment using SMART room and associated techniques
Self-regulation difficulties
Domains B, C and D on the Developmental trauma disorder semistructured interview (DTD-SI). Scores on DTD-SI range from 0-15, where higher scores mean more self-regulation difficulties (and worse outcome).
Time frame: The outcome is assessed by trained study personell at Baseline (Day 1) and at follow up 6 months and 12 months after Baseline.
International Trauma Questionnaire (ITQ)
Core features of PTSD and complex PTSD. We use total scores and subdomain scores. Total scores range from 0-72, where higher scores mean worse outcome. Subdomain scores for each of PTSD and complex PTSD range from 0-36, and also here higher scores mean worse outcome.
Time frame: The outcome is assessed by trained study personell at Baseline (Day 1) and at follow up 6 months and 12 months after Baseline.
Strenght and Difficulties Questionnaire (SDQ)
Psychosocial problems and strengths, based on assessing five domains: emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behavior. The study will use a total difficulties score based on the first 4 of the 5 subdomains of SDQ, with scores ranging from 0-40, where higher scores mean worse outcome. The study also will use a total score for the fifth domain alone, about psychosocial strenghts, with scores ranging from 0-10 and higher scores meaning better outcome.
Time frame: Assessed at baseline and 6 and 12 months follow up
Child Behavior Checklist (CBCL/6-18)/ Youth self-report (YRS) from ASEBA
CBCL/6-18 / YRS 6-18 consist of 113 behavioral items, scored on a 3-point scale ranging from 0 ("not true") to 2 ("very true" (2). Based on factor analysis and norm data, raw scores are translated into T-scores (0-100, mean 50) for an array of scales by using ASEBA software. The study will use T-scores (or eventually raw scores) for the following scales: (i) Eight syndrome scales (anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior, and aggressive behavior); (ii) Total problems - sum of scores from all eight syndrome scales (iii); Externalizing problems (sum of rule-breaking and aggressive behavior scores); (iv) Internalizing problems (sum of anxious/depressed, withdrawn/depressed, and somatic complaints scores), (v); Dysregulation (based on 18 items); (vi) six DSM-IV-oriented scales, and (vii) Adaptive functioning scale (14 items). Higher scores generally mean worse outcome, but opposite for (vii).
Time frame: Assessed at baseline and at 6 and 12 months follow up
Child outcome rating scale (CORS)
CORS provides a measure of subjective well-being. CORS consists of 4 items that are scored on a visual analogue scale, with scores for each item ranging from 0-10. Total score on CORS range from 0-40, where higher scores mean better outcome.
Time frame: Assessed at baseline and at 6 and 12 months follow up
Therapeutic alliance scale for children - revised (TASC-R)
TASC-R is a measure of therapeutic alliance or working alliance. Scores on TASC-R range from 12 to 48, where higher scores mean better outcome
Time frame: Measured after the 3rd and the 7th psychotherapy treatment session, that is, 3 and 7 weeks after Baseline - since participants will receive one psychotherapy treatment session per week.
Session rating scale for children (CSRS)
CSRS is a measure of therapeutic alliance or working alliance. Four items are scored on visual analogue scales, each representing scores from 0-10, with total scores on CSRS ranging from 0-40. Higher scores mean better outcome.
Time frame: Measured after the 3rd and the 7th psychotherapy treatment session, that is, 3 and 7 weeks after Baseline - since participants will receive one psychotherapy treatment session per week.
Plan to share: No
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Started Oct 2025 (actual). Primary completion is estimated for Dec 2028, 38 months after the start.
Of 50 non-industry interventional studies with no phase under Stress Disorders, Traumatic, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 49. This study's planned 38 months is above that.
Counting every sponsor, half of 52 studies reached it within 33 months; a quarter within 14 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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Vestre Viken Hospital Trust