Stress Disorders, TraumaticUTVIDNCT07200713
Effect Study of SMART Treatment for Youth
A study testing Treatment as usual (TAU) and Sensory motor arousal regulation treatment (SMART) in people with Stress Disorders, Traumatic and Psychological Trauma, run by Vestre Viken Hospital Trust at 4 sites in Norway.
Trial 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 self-regulation difficulties. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Stress Disorders, Traumatic, Psychological Trauma, Sexual Trauma
- What is being tested?
- Treatment as usual (TAU) and Sensory motor arousal regulation treatment (SMART)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesNorway
- Study dates
- 15 Oct 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
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- 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
Who cannot join
- Active psychosis
- Not fluent in Norwegian language
- Developmental challenges - IQ < 70
- Has previously used SMART room
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway4 sites, 4 recruiting
- Recruiting
Dpt of Child and Adolescent Mental Health (CAMH) Vestre Viken - Ringerike Ål
Ål, Buskerud
Monika Kleven, Psy.D, +47 90121036, monkle@vestreviken.no
- Recruiting
Dpt of Child and Adolescent Mental Health (CAMH) Vestre Viken - Asker
Asker, Akershus
Maria M Mahlum, Psy.D, +47 90088284, maria.moen.mahlum@vestreviken.no
- Recruiting
Dpt of Child and Adolescent Mental Health (CAMH) Vestre Viken - Drammen
Drammen, Buskerud
Maria M Mahlum, Psy.D, +47 90088284, maria.moen.mahlum@vestreviken.no
- Recruiting
Dpt of Child and Adolescent Mental Health (CAMH) Vestre Viken - Kongsberg
Kongsberg, Buskerud
Margrerthe B Brenna, Psy.D, +47 94368057, margrethe.borresen.brenna@vestreviken.no
About this study
Official title: A Randomized Controlled Evaluation of Sensory Motor Arousal Regulation Treatment (SMART) for Youth With Developmental Trauma and Self-regulation Difficulties
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:
- Regulatory capacities of emotions and bodily states, attention and behavior, and self and social relations
- 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)
- Internalizing symptoms (somatic complaints, anxiety symptoms and depression symptom severity) and Externalizing symptoms (conduct problems, aggression, inattention, and social problem severity)
- Psychosocial strengths - prosocial behavior, subjective well-being and impairment in peer relationships, family relationships, and academic/school functioning
- 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
- 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.
Read the 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 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.
- Conditions
- Stress Disorders, Traumatic, Psychological Trauma, Sexual Trauma, Stress Disorders, Post-Traumatic; Mental Disorders
- Being tested
- Treatment as usual (TAU), Sensory motor arousal regulation treatment (SMART)
- Keywords
- Randomized controlled trial, Developmental trauma disorder, self-regulation difficulties, trauma treatment, Sensory motor arousal regulation treatment (SMART), Children, Youth, Outpatient treatment, Treatment as usual
- Medical subject headings
- Stress Disorders, Traumatic, Psychological Trauma, Sexual Trauma, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best practice ordinary psychological treatment
Sensory motor arousal regulation treatment (SMART)Other
Psychological treatment using SMART room and associated techniques
| Study group | Role | What they receive |
|---|---|---|
| Sensory motor arousal regulation treatment (SMART) | Experimental | Treatment using SMART rooms and associated SMART techniques Receives: Other: Sensory motor arousal regulation treatment (SMART) |
| Treatment as usual (TAU) | Active comparator | Best practice ordinary treatment without using SMART approaches Receives: Other: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The outcome is assessed by trained study personell at Baseline (Day 1) and at follow up 6 months and 12 months after Baseline.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Assessed at baseline and at 6 and 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start15 Oct 2025
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At each of four study sites, the study uses blocked randomization with alternating block sizes of 4 and 6.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roar Fosse, Ph.D., Principal investigator, Vestre Viken Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200713
- Sponsor's protocol ID
- 881408
- Acronym
- UTVID
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Evaluation of Sensory Motor Arousal Regulation Treatment (SMART) for Youth With Developmental Trauma and Self-regulation Difficulties
- ClinicalTrials.gov ID
- NCT07200713
- Acronym / sponsor ID
- UTVID / 881408
- Conditions
- Stress Disorders, Traumatic, Psychological Trauma, Sexual Trauma, Stress Disorders, Post-Traumatic; Mental Disorders
- Keywords
- Randomized controlled trial, Developmental trauma disorder, self-regulation difficulties, trauma treatment, Sensory motor arousal regulation treatment (SMART), Children, Youth, Outpatient treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Regulatory capacities of emotions and bodily states, attention and behavior, and self and social relations
- 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)
- Internalizing symptoms (somatic complaints, anxiety symptoms and depression symptom severity) and Externalizing symptoms (conduct problems, aggression, inattention, and social problem severity)
- Psychosocial strengths - prosocial behavior, subjective well-being and impairment in peer relationships, family relationships, and academic/school functioning
- 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
- 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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- At each of four study sites, the study uses blocked randomization with alternating block sizes of 4 and 6.
| Arm | Type | Receives |
|---|---|---|
| Sensory motor arousal regulation treatment (SMART) | Experimental | Other: Sensory motor arousal regulation treatment (SMART)Treatment using SMART rooms and associated SMART techniques |
| Treatment as usual (TAU) | Active comparator | Other: Treatment as usual (TAU)Best practice ordinary treatment without using SMART approaches |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
- 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)
Key exclusion criteria (4 listed)
- Active psychosis
- Not fluent in Norwegian language
- Developmental challenges - IQ < 70
- Has previously used SMART room
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as usual (TAU)Best practice ordinary psychological treatment | Other | Treatment as usual (TAU) |
| Sensory motor arousal regulation treatment (SMART)Psychological treatment using SMART room and associated techniques | Other | Sensory motor arousal regulation treatment (SMART) |
Primary outcome
Self-regulation difficulties
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.
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).
4 secondary outcomes
International Trauma Questionnaire (ITQ)
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)
Time frame: Assessed at baseline and 6 and 12 months follow up
Child Behavior Checklist (CBCL/6-18)/ Youth self-report (YRS) from ASEBA
Time frame: Assessed at baseline and at 6 and 12 months follow up
Child outcome rating scale (CORS)
Time frame: Assessed at baseline and at 6 and 12 months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roar Fosse, Ph.D. principal investigator
Vestre Viken Hospital Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as usual (TAU) and Sensory motor arousal regulation treatment (SMART) in people with Stress Disorders, Traumatic and Psychological Trauma, run by Vestre Viken Hospital Trust at 4 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roar Fosse, Ph.D. (+47 95008051, roar.fosse@vestreviken.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-regulation difficulties (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.