Effect Study of SMART Treatment for Youth

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. 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:

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

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.

Conditions

• Stress Disorders, Traumatic
• Psychological Trauma
• Sexual Trauma
• Stress Disorders, Post-Traumatic; Mental Disorders

Interventions

OTHER

Treatment as usual (TAU)

Best practice ordinary psychological treatment

OTHER

Sensory motor arousal regulation treatment (SMART)

Psychological treatment using SMART room and associated techniques

Sponsors & Collaborators

• Vestre Viken Hospital Trust

  lead OTHER

Principal Investigators

• Roar Fosse, Ph.D. · Vestre Viken Hospital Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-25

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• Norway

Study Locations