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.
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)
Active psychosis
Not fluent in Norwegian language
Developmental challenges - IQ < 70
Has previously used SMART room
Parallel
Treatment as usual (TAU)
Other interventionBest practice ordinary psychological treatment
Sensory motor arousal regulation treatment (SMART)
Other interventionPsychological 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).
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.
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.
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).
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.
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
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.
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