Effect Study of SMART Treatment for Youth

NCT07200713 | Not Yet Recruiting

• 1 other identifier: 881408
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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 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:

1. 1.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:
2. 2.Regulatory capacities of emotions and bodily states, attention and behavior, and self and social relations
3. 3.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)
4. 4.Internalizing symptoms (somatic complaints, anxiety symptoms and depression symptom severity) and Externalizing symptoms (conduct problems, aggression, inattention, and social problem severity)
5. 5.Psychosocial strengths - prosocial behavior, subjective well-being and impairment in peer relationships, family relationships, and academic/school functioning
6. 6.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

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; Treatment as usual

Outcome Measures

Primary Outcomes (1)

• 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).

  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)

  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)

  Assessed at baseline and 6 and 12 months follow up

• Child Behavior Checklist (CBCL/6-18)/ Youth self-report (YRS) from ASEBA

  Assessed at baseline and at 6 and 12 months follow up

• Child outcome rating scale (CORS)

  Assessed at baseline and at 6 and 12 months follow up

Other Outcomes (2)

• Therapeutic alliance scale for children - revised (TASC-R)

  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)

  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.

Study Arms (2)

Sensory motor arousal regulation treatment (SMART)

EXPERIMENTAL

Treatment using SMART rooms and associated SMART techniques

Other: Sensory motor arousal regulation treatment (SMART)

Treatment as usual (TAU)

ACTIVE COMPARATOR

Best practice ordinary treatment without using SMART approaches

Other: Treatment as usual (TAU)

Interventions

Sensory motor arousal regulation treatment (SMART) OTHER

Psychological treatment using SMART room and associated techniques

Sensory motor arousal regulation treatment (SMART)

Treatment as usual (TAU) OTHER

Best practice ordinary psychological treatment

Treatment as usual (TAU)

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Active psychosis
• Not fluent in Norwegian language
• Developmental challenges - IQ \< 70
• Has previously used SMART room

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead

Study Sites (4)

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

Asker, Akershus, Norway

Location

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

Ål, Buskerud, Norway

Location

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

Drammen, Buskerud, Norway

Location

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

Kongsberg, Buskerud, Norway

Location

MeSH Terms

Conditions

Stress Disorders, Traumatic; Psychological Trauma; Sexual Trauma; Mental Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders

Study Officials

• Roar Fosse, Ph.D.

  Vestre Viken Hospital Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roar Fosse, Ph.D.

CONTACT

+47 95008051; roar.fosse@vestreviken.no

Maria M Mahlum, Psy.D.

CONTACT

+47 90088284; maria.moen.mahlum@vestreviken.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: At each of four study sites, the study uses blocked randomization with alternating block sizes of 4 and 6.

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: October 1, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (4)