Switch to Lisdexamfetamine in the Treatment of Attention-Deficit Disorder at a Psychiatric Outpatient Clinic for School-Aged Children: A Danish Cohort Study.

Objectives: This study aimed to examine switch from first-line methylphenidate (MPH) to lisdexamfetamine (LDX) in school-aged children with attention-deficit/hyperactivity disorder (ADHD). Methods: This is a retrospective observational study based on systematic review of patient records of all children (7-13 years) diagnosed with ADHD and referred to a Danish specialized outpatient clinic. The study included 394 children switching from MPH to LDX as either second-line or third-line treatment (atomoxetine [ATX] as second-line treatment) during the study period from April 1, 2013, to November 5, 2019. Results: One in five children switched from MPH to LDX at some point during the study period. The most frequent reasons for switching to LDX were adverse effects (AEs; 70.0% for MPH, 68.3% for ATX) and lack of efficiency (52.0% for MPH, 72.7% for ATX). Top five AEs of LDX were decreased appetite (62.4%), insomnia (28.7%), irritability/aggression (26.1%), weight decrease (21.1%), and mood swings (13.9%). MPH and LDX had similar AE profiles, yet most AEs were less frequent after switching to LDX. At the end of the study period, the majority were prescribed LDX as second-line rather than third-line treatment (86.1% in 2019). However, the likelihood of LDX as second-line treatment decreased with the number of psychiatric comorbidities, ADHD symptom severity as assessed by parents, and if AEs were a reason for MPH discontinuation. Among children observed for at least 1 year after initiation of LDX, 41.3% continued LDX treatment for a year or longer. LDX continuation was less likely if AEs were a reason for MPH discontinuation. Similarly to MPH and ATX, the most frequent reasons for LDX discontinuation were AEs (74.4%) and lack of efficiency (34.7%). Implications: The findings support LDX as an important option in the personalized treatment of children with ADHD and may support prescribers in the clinical decision-making on switching medication.

Exploring latent clusters in pediatric OCD based on symptoms, severity, age, gender, and comorbidity.

Given diverse symptom expression and high rates of comorbid conditions, the present study explored underlying commonalities among OCD-affected children and adolescents to better conceptualize disorder presentation and associated features. Data from 830 OCD-affected participants presenting to OCD specialty centers was aggregated. Dependent mixture modeling was used to examine latent clusters based on their age- and gender adjusted symptom severity (as measured by the Children's Yale-Brown Obsessive-Compulsive Scale; CY-BOCS), symptom type (as measured by factor scores calculated from the CY-BOCS symptom checklist), and comorbid diagnoses (as assessed via diagnostic interviews). Fit statistics favored a four-cluster model with groups distinguished primarily by symptom expression and comorbidity type. Fit indices for 3-7 cluster models were only marginally different and characteristics of the clusters remained largely stable between solutions with small clusters of distinct presentations added in more complex models. Rather than identifying a single classification system, the findings support the utility of integrating dimensional, developmental, and transdiagnostic information in the conceptualization of OCD-affected children and adolescents. Identified clusters point to the centrality of contamination concerns to OCD, relationships between broader symptom expression and higher levels of comorbidity, and the potential for complex/neurodevelopmental presentations.

One year follow-up of participants in a randomised controlled trial of a CBT-based group therapy programme for adolescents diagnosed with ADHD.

BACKGROUND: Adolescents with ADHD often struggle on many areas of their lives and have a high risk of adverse outcomes and negative life trajectories. Multimodal treatment including psychosocial interventions is recommended but evidence regarding effect of such interventions is still limited. MATERIALS AND METHODS: This study was a follow-up study of adolescents participating in a randomised controlled trial (RCT) of a group intervention based on cognitive behavioural therapy (CBT). Participants were adolescents diagnosed with ADHD and still impaired by their symptoms after standard treatment including psychoeducation and medication. All participants were interviewed by telephone one year after inclusion, and outcome measures included both quantitative and qualitative measures. RESULTS: There were 100 adolescents included in the study. We found no significant differences between treatment and control group on measures of ADHD-symptoms, self-efficacy, overall problems, global psychosocial functioning, or symptom severity at one-year follow-up. Still, participants in the intervention group reported on positive gains and that they learned a lot about ADHD and themselves. CONCLUSIONS: The intervention delivered in this trial failed to show a treatment effect on symptom level when added to standard care. Participants did however report on positive gains and felt they learned a lot. More research is needed to explore how the programme and delivery of treatment might be improved, and which patients might benefit the most from this type of interventions.

Is Attention-Deficit/Hyperactivity Disorder (ADHD) a Dimension or a Category? What Does the Relationship Between ADHD Traits and Psychosocial Quality of Life Tell Us?

OBJECTIVE: The question of whether attention-deficit/hyperactivity disorder (ADHD) is a discrete category or a continuous dimension remains clinically relevant. We report the first examination of this question from the viewpoint of the relationship between ADHD traits and psychosocial quality of life (QoL), and whether the level of QoL declines markedly around a certain high ADHD trait range suggestive of a categorical boundary. METHODS: Parents/caregivers of 1,967 schoolchildren aged 6 to 11 from the general population completed the Pediatric Quality of Life Inventory and the ADHD-Rating Scale IV. Piecewise linear and non-linear regression analyses were performed. RESULTS: No evidence for a non-linear association or an abrupt change in the rate of decrease in QoL was observed in the high end of the ADHD traits continuum. Instead, the relationship was consistent with linearity. CONCLUSION: Psychosocial QoL gradually declines in a linear manner as ADHD trait levels increase providing further support for a dimensional model.

[Formula: see text] Executive function measured by BRIEF in adolescents diagnosed and treated for ADHD: problem profiles and agreement between informants.

Executive functional deficits (EFDs) play an important role in functional impairment in adolescents with attention deficit/hyperactivity disorder (ADHD). More knowledge of executive function (EF) profiles and informant discrepancies will guide clinicians and provide tailored treatment advice. The objectives of this study were to use teacher, parent, and self-reported EF ratings to describe (a) problem profiles and (b) the correlation and agreement between informants. This study included 100 adolescents aged 14-18 years with ADHD still experiencing clinically impairing symptoms despite standard treatment including medication. EFs were measured using the Behavior Rating Inventory of Executive Function (BRIEF). Agreement between informants was quantified using Pearson correlation and informant discrepancies were analyzed using paired samples t-test. Overall, the results indicated considerable EFDs in the study population. Correlation and agreement varied between the informants. Agreement was highest between adolescents and their parents, especially for female participants, and lowest between male participants and their teachers. Teachers reported the highest level of EFDs, whereas adolescents generally self-reported EFDs at a lower level than both parents and teachers. Identifying and tailoring treatment for EFDs might improve future prognosis for adolescents with ADHD, however, self-awareness of these difficulties is a challenge that needs to be considered when planning interventions.

Remission and Relapse Across Three Years in Pediatric Obsessive-Compulsive Disorder Following Evidence-Based Treatments.

OBJECTIVE: To examine relapse rates following remission in a 3-year follow-up study in pediatric patients with obsessive-compulsive disorder (OCD) treated with cognitive-behavioral therapy (CBT) in a first step, and either continued CBT or sertraline (randomized selection) in a second step. METHOD: Participants (N = 269) fulfilled DSM-IV OCD criteria with a mean severity on the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) of 24.6 (SD = 5.1) and were included in analyses according to intent-to-treat principles. CBT used manualized exposure and response prevention (ERP) during both steps 1 and 2, and step 2 sertraline medication used flexible dosing. The follow-up schedules were timed to 6, 12, 24, and 36 months following step 1 CBT. Remission was defined as a CY-BOCS score ≤10 and relapse as an elevated CY-BOCS score ≥16 in those who had remitted. RESULTS: A good third of our patients were in stable and full remission at all examinations (n = 98, 36.4%). Further, some in remission following treatment (n = 36, 13.4%) had mild OCD at some examinations. Relapses during follow-up were not uncommon (n = 28, 10.4%), but in many patients these improved again (n = 10, 3.7%) and were in remission at the final 3-year follow-up. Furthermore, a considerable proportion (n = 50, 18.6%) of the patients were initial non-remitters to the treatment but achieved remission at some point during the follow-up. In addition, 11.5% (n = 31) had persistent OCD but reached remission by the last follow-up. Finally, a smaller segment of our sample (9.7%, n = 26), did not attain remission at any point during the study. CONCLUSION: Our outcome paints a more promising picture of pediatric OCD long-term outcome than previous studies have done. However, both relapse rates and the presence of initial non-remitters and persistent OCD show that treatments need improvement, particularly for those who respond slowly, partially, or not at all. The lack of a general psychiatric interview at follow-up is a marked limitation. CLINICAL TRIAL REGISTRATION INFORMATION: Nordic Long-term Obsessive compulsive disorder (OCD) Treatment Study; https://www.isrctn.com; ISRCTN66385119.

Family Accommodation in Pediatric Obsessive-Compulsive Disorder: Investigating Prevalence and Clinical Correlates in the NordLOTS Study.

Family accommodation (FA) involves the actions taken by family members, particularly parents, to accommodate a child´s obsessive-compulsive disorder (OCD) symptoms, reducing distress or impairment. This behavior may maintain compulsive and avoidant behavior, preventing corrective learning or habituation. This study aims to investigate the prevalence and factors influencing FA in a large Scandinavian sample of children with OCD. We assessed 238 children using standardized diagnostic interviews, OCD symptom severity assessments and questionnaires evaluating functional impairment and internalizing and externalizing symptoms. FA was measured using the Family Accommodation Scale, a 12-item clinician-rated interview. Our results confirmed a high frequency of accommodation, with approximately 70% of primary caregivers reporting some accommodation daily and 98% at least once per week. FA was associated with increased OCD symptom severity, contamination/cleaning symptoms, internalizing and externalizing behavior, and functional impairment. Linear regression analysis showed that high levels of FA are specifically associated with lower age, higher OCD symptom severity, parent-reported impairment, internalizing, and externalizing symptoms. A path analysis revealed that FA partially mediated the relationship between OCD severity, externalizing symptoms, and child's age, highlighting the role of FA in the progression of OCD and related symptoms. The findings emphasize the importance of evaluating FA before initiating treatment and specifically addressing it during the therapeutic process.

Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial.

Background: Knowledge on adverse events in psychotherapy for youth with OCD is sparse. No official guidelines exist for defining or monitoring adverse events in psychotherapy. Recent recommendations call for more qualitative and quantitative assessment of adverse events in psychotherapy trials. This mixed methods study aims to expand knowledge on adverse events in psychotherapy for youth with OCD. Methods: This is an analysis plan for a convergent mixed methods study within a randomized clinical trial (the TECTO trial). We include at least 128 youth aged 8-17 years with obsessive-compulsive disorder (OCD). Participants are randomized to either family-based cognitive behavioral therapy (FCBT) or family-based psychoeducation and relaxation training (FPRT). Adverse events are monitored quantitatively with the Negative Effects Questionnaire. Furthermore, we assess psychiatric symptoms, global functioning, quality of life, and family factors to investigate predictors for adverse events. We conduct semi-structured qualitative interviews with all youths and their parents on their experience of adverse events in FCBT or FPRT. For the mixed methods analysis, we will merge 1) a qualitative content analysis with descriptive statistics comparing the types, frequencies, and severity of adverse events; 2) a qualitative content analysis of the perceived causes for adverse events with prediction models for adverse events; and 3) a thematic analysis of the participants' treatment evaluation with a correlational analysis of adverse events and OCD severity. Discussion: The in-depth mixed methods analysis can inform 1) safer and more effective psychotherapy for OCD; 2) instruments and guidelines for monitoring adverse events; and 3) patient information on potential adverse events. The main limitation is risk of missing data. Trial registration: ClinicalTrials.gov identifier: NCT03595098. Registered on July 23, 2018.

Effect modification of an effective transdiagnostic cognitive behavioral psychotherapy in youths with common mental health problems: Secondary analyses of the randomized mind-my-mind trial.

Mind My Mind (MMM) cognitive behavioral therapy (CBT) manualized treatment is effective in the management of common emotional and behavioral mental health problems in youth, yet not all individuals respond satisfactorily to treatment. This study explored potential effect modifiers, i.e., baseline factors associated with a differential treatment effect. We conducted secondary effect modifier analyses with MMM trial data, which involved randomization of 396 youths aged 6-16 years to either MMM CBT treatment (9-13 sessions) or management as usual in local community settings. We examined sociodemographic- (sex, age, family composition, ethnicity, parental education, and income) and clinical variables (mental disorders and duration of mental health problems) as potential effect modifiers of the a) change in parent-rated impact of mental health problems measured by the Strengths and Difficulties Questionnaire (SDQ) or b) response (reduction of ≥1 on SDQ-impact). In intention-to-treat analyses, superior treatment (net) benefits from the MMM intervention were found among youths who met criteria for any mental disorder at baseline (-1.25 [95%CI: -1.67;-0.82]) compared to youths that did not meet diagnostic criteria (-0.22 [95%CI:-1.09;0.65]). Comorbidity vs no comorbidity (-1.84 [95%CI:-2.58;-1.10] vs -0.72 [95%CI:-1.15;-0.29]) and longer duration of untreated mental health problems, i.e., more vs less than 6 months (-1.16 [95%CI:-1.55;-0.78] vs 0.43 [95%CI:-1.01;1.86]) were also associated with superior treatment benefits. The sociodemographic factors were not associated with differential treatment effects in the intention-to-treat analyses. These findings suggest that community-based programs like the MMM are well-suited for youths with substantial mental health problems. Clinical Trials Identifier: NCT03535805.

Prevalence of chronic and multisite pain in adolescents and young adults with ADHD: a comparative study between clinical and general population samples (the HUNT study).

Attention-deficit/hyperactivity disorder (ADHD) and chronic pain are prevalent and associated. We examined the prevalence and distribution of chronic pain in adolescents and young adults with ADHD using 9-years longitudinal data (from T1:2009-2011 to T3:2018-2019) with three time points from a clinical health survey compared to two age-matched reference population-based samples. Mixed-effect logistic regression and binary linear regression were used to estimate the probability for chronic and multisite pain at each time point and to compare the prevalence of chronic pain with the reference populations. The prevalence of chronic and multisite pain was high in those with ADHD, especially in female young adults, with highly prevalent chronic pain at 9 years of follow-up (75.9%) compared to 45.7% in females in the reference population. The probability of having pain was only statistically significant for chronic pain in males at 3 years of follow-up (41.9%, p = 0.021). Those with ADHD were at higher risk of reporting single-site and multisite pain compared to the general population at all measurement points. Longitudinal studies should be tailored to further understand the complex sex differences of comorbid chronic pain and ADHD in adolescents, exploring predictive factors of pain assessing long-term associations with bodyweight, psychiatric comorbidities, and possible mechanisms of stimulant use effects on pain.

Do Autistic Traits Predict Outcome of Cognitive Behavioral Therapy in Pediatric Obsessive-Compulsive Disorder?

The first aim of this study was to explore whether children with obsessive compulsive disorder (OCD) and subclinical autistic traits can be differentiated from children with OCD without these traits based on clinical OCD-related characteristics, distinct OCD symptom patterns, and type of comorbidity. The second aim was to investigate whether autistic traits predict immediate and long-term outcome of exposure-based cognitive behavioral therapy (CBT) in pediatric OCD.The participants in this study were a total of 257 children and adolescents aged 7-17 years, recruited from Denmark, Norway, and Sweden as a part of the Nordic long-term OCD treatment study (NordLOTS). Inclusion criteria were an OCD diagnosis based on DSM-IV criteria and a Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) total severity score of 16 or higher. No children with a diagnosis on the autism spectrum were included. An Autism Spectrum Screening Questionnaire (ASSQ) cut-off score of ≥ 17 was used to define the group of OCD patients with autistic traits and all participants were treated with 14 weekly sessions of manualized CBT.Comorbid attention-deficit/hyperactivity disorder and tic disorders, subclinical internalizing and externalizing symptoms, lower insight into OCD symptoms, more indecisiveness and pervasive slowness, and ordering/arranging OCD symptoms were found to be significantly associated with having OCD with autistic traits. No difference was found between the groups on treatment outcomes.Results suggest that children and adolescents with OCD and autistic traits portray a different clinical profile than those without these traits, but that CBT is equally effective for those with and without autistic traits.

Long-term functional impairment in pediatric OCD after and during treatment: An analysis of distinct trajectories.

The present study aimed to: (a) identify latent class trajectories of OCD-related functional impairment, before, during and over three years after stepped-care treatment in children and adolescents with OCD; (b) describe these classes according to pretreatment characteristics; (c) identify predictors of trajectory class membership and (d) examine the relationship of functional impairment trajectory classes with OCD symptom severity trajectory classes. The sample consisted of 266 children and adolescents (aged 7-17 years) with OCD, participating in the Nordic long-term OCD treatment study. Latent class growth analysis was conducted using Child Obsessive-Compulsive Impact Scale-Revised (COIS-R) data from children and parents on seven assessment points over a three-year period. A 3-class solution was identified. The largest class (70.7%) initiated treatment with lower functional impairment and obtained moderate reduction which was maintained over time. The second class (24.4%) initiated with higher functional impairment which rapidly diminished over time. The third and smallest class (4.9%), initiated with moderate functional impairment which remained stable over time. The classes differed on measures of OCD severity and comorbid symptoms. Most participants improved with treatment and maintained low levels of impairment. However, a subgroup distinguished by higher levels of ADHD symptoms, remained at pretreatment levels of impairment throughout.

Validation of the Weiss Functional Impairment Rating Scale (WFIRS-P) as a Functional Impairment Measure in a General Population of Schoolchildren.

Functional impairment rating scales are few in numbers and have mainly been examined in clinical populations. The Weiss Functional Impairment Rating Scale-Parent report (WFIRS-P) is a case in point. We tested the psychometric properties of the WFIRS-P in the largest general population study to date and for the first time examined the factor structure of the scale in a general population setting. Participants were 2,027 schoolchildren aged 6 to 11. Parents/caregivers completed the WFIRS-P and criterion measures of quality of life, attention-deficit/hyperactivity disorder, and behavioral/emotional symptoms. Confirmatory factor analysis and convergent/divergent validity analyses supported a six-factor structure: family, life skills, self-concept, social activities, and the separation of the school domain into two smaller domains covering school learning and school behavior. Children with and without a history of referral differed significantly on all six domains supporting the external validity. In conclusion, the WFIRS-P was found to generate valid scores in a general population sample.

Motor function in early onset schizophrenia-A 2-year follow-up study.

AIM: Motor symptoms primarily assessed by clinical rating are documented across the schizophrenia spectrum, but no studies have examined the longitudinal course of these symptoms in adolescents using tests that control for the natural maturational process. The aim is therefore to compare fine and gross motor function using age-adjusted tests in adolescents with schizophrenia and controls across a 2-year period, and examine if clinical correlates contribute to changes in motor function in adolescents with schizophrenia. METHOD: Motor function assessed by two age-adjusted tests was compared in 25 adolescents with schizophrenia and age- and sex-matched controls over a 2-year period using t-tests, Cohen's D and χ2 tests. Linear mixed models with a random intercept at patient level were used to assess changes between baseline and follow-up. The latter approach was adopted to assess the association between changes and potential predictors as age, sex, complications during labour/delivery, childhood motor function, symptoms severity, executive function and antipsychotics. RESULT: All measures of motor function but one significantly differentiated adolescents with schizophrenia from controls with large effect sizes at 2-year follow-up. The overall scores did not change during follow-up, whereas two resembling motor areas of the tests significantly improved in adolescents with schizophrenia. The severity of schizophrenia, sex and IQ revealed association with the changes. CONCLUSION: The finding of both stability and improvements from diagnosis to follow-up in adolescents with schizophrenia and the differences between adolescents with and without schizophrenia argue in favour of the neurodevelopment hypothesis and highlights the need for assessing motor function.

Body Dysmorphic Symptoms in Youth with Obsessive-compulsive Disorder: Prevalence, Clinical Correlates, and Cognitive Behavioral Therapy Outcome.

The aims of the study were to estimate the prevalence of body dysmorphic symptoms in a sample of children and adolescents with obsessive-compulsive disorder, possible clinical correlates and whether BDD symptoms predict poorer treatment outcomes after cognitive behavioral therapy. The study included 269 children and adolescents with OCD, aged 7-17 years, from Denmark, Sweden, and Norway, who were treated with 14 weekly sessions of manualized, exposure-based CBT. Twenty-one patients (7.8%) had BDD symptoms. BDD symptoms were associated with older age (p = 0.003) and a higher prevalence of comorbid anxiety disorders (p = 0.025). In addition, patients with BDD symptoms endorsed a greater number of OCD symptoms than did those without BDD symptoms. Having symptoms of BDD did not affect the CBT outcome on OCD. The results of the study suggest that CBT for OCD is equally effective for those with and without comorbid BDD symptoms.

Functional somatic symptoms in preschool attention-deficit/hyperactivity disorder: a secondary analysis of data from a randomized controlled trial of parent training.

Children with attention-deficit/hyperactivity disorder (ADHD) can be more stress-vulnerable, and thereby, it has been suggested, prone to develop functional somatic symptoms (FSS) compared to their peers. In this paper, using data from 160 children aged 3-7 years with ADHD from the D'SNAPP study, a randomized controlled trial testing a parent training intervention, we addressed a number of questions about the role of FSS in ADHD. First, are FSS levels higher in an ADHD sample than in the children of the general population. Second, do FSS levels predict psychopathology and health-related quality of life (HRQoL) in ADHD samples. Third, does FSS levels moderate the effect of parent training on ADHD symptoms. We found that preschoolers with ADHD experienced more severe FSS than a general population-based sample (18.80% vs. 2.11%). Severe FSS were associated with increased psychopathology and impaired daily function and lower HRQoL. Level of baseline FSS did not moderate the effect of parent training on ADHD. FSS in preschool children with ADHD is associated with impaired daily functioning, but further research is warranted to determine the clinical impact of FSS in children with ADHD.

Parent Training for ADHD: No Generalization of Effects From Clinical to Neuropsychological Outcomes in a Randomized Controlled Trial.

OBJECTIVE: We examined whether neuropsychological function in ADHD can be improved by the New Forest Parenting Programme (NFPP), that combines standard parenting strategies with self-regulatory skills training, or predict ADHD and quality of life (QoL) treatment effects. METHOD: Participants were 93 medication-naive preschool children with ADHD (3-7 years) randomized to either NFPP (n = 49) or treatment as usual (TAU; n = 44) in a recent randomized trial. Laboratory measures of executive function, reaction time variability, and delay of gratification were collected along with parent ratings of ADHD and QoL at baseline and post treatment. Ratings were collected again at 3-month follow-up. RESULTS: NFPP did not improve neuropsychological function (compared to TAU), and baseline neuropsychological function did not predict treatment-related ADHD or QoL effects. CONCLUSION: Although NFPP includes a neuropsychological training element and has been shown to improve several clinical outcomes, it did not improve the neuropsychological functions it targets.

Specific Contamination Symptoms are Associated with Experiencing a Limited Response of Cognitive-Behavioral Therapy in Pediatric Patients with OCD.

A recent study identified three distinct treatment-response trajectories in pediatric OCD where higher levels of contamination symptoms predicted a limited response to cognitive-behavioral therapy (CBT). This study extends these findings by examining which specific symptoms characterize limited CBT response from baseline to 3-year follow-up, with an emphasis on contamination symptoms. The study sample comprised 269 pediatric patients with OCD, all receiving stepped-care treatment with manualized CBT. Differences in single item-reporting between the three trajectory groups were examined using linear mixed-effect modeling. Limited responders displayed a higher symptom load across all OCD symptom categories at 3-year follow-up, dominated by contamination symptoms. Five of these (obsessions about dirt and germs, about bodily fluids, about the feeling of contamination and compulsions regarding handwashing and showering) showed persistence from baseline to 3-year follow-up. The results indicate that presence of specific contamination symptoms may influence long-term symptom severity trajectories in young patients with OCD.

Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents (the TECTO trial): a statistical analysis plan for the randomised clinical trial.

BACKGROUND: Obsessive-compulsive disorder (OCD) is a debilitating psychiatric disorder which affects up to 3% of children and adolescents. OCD in children and adolescents is generally treated with cognitive behavioural therapy (CBT), which, in more severely affected patients, can be combined with antidepressant medication. The TECTO trial aims to compare the benefits and harms of family-based CBT (FCBT) versus family-based psychoeducation/relaxation training (FPRT) in children and adolescents aged 8 to 17 years. This statistical analysis plan outlines the planned statistical analyses for the TECTO trial. METHODS: The TECTO trial is an investigator-initiated, independently funded, single-centre, parallel-group, superiority randomised clinical trial. Both groups undergo 14 sessions of 75 min each during a period of 16 weeks with either FCBT or FPRT depending on the allocation. Participants are randomised stratified by age and baseline Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score. The primary outcome is the CY-BOCS score. Secondary outcomes are health-related quality of life assessed using KIDSCREEN-10 and adverse events assessed by the Negative Effects Questionnaire (NEQ). Primary and secondary outcomes are assessed at the end of the intervention. Continuous outcomes will be analysed using linear regression adjusted for the stratification variables and baseline value of the continuous outcome. Dichotomous outcomes will be analysed using logistic regression adjusted for the stratification variables. The statistical analyses will be carried out by two independent blinded statisticians. DISCUSSION: This statistical analysis plan includes a detailed predefined description of how data will be analysed and presented in the main publication before unblinding of study data. Statistical analysis plans limit selective reporting bias. This statistical analysis plan will increase the validity of the final trial results. TRIAL REGISTRATION: ClinicalTrials.gov NCT03595098. July 23, 2018.