[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659465":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":49,"studyPopulation":39,"armGroups":50,"interventions":61,"overallOfficials":39,"centralContacts":67,"locations":39,"responsibleParty":74,"collaborators":78,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":39,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":110,"whyStopped":39,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":39},{"fullName":5,"class":6},"Aarhus University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":32,"otherOutcomes":39},[9,13,17,21,25,28,30],{"measure":10,"description":11,"timeFrame":12},"Feasibility and acceptability","Participant retention: the number of included participants fulfilling the training program and evaluation at end of treatment, higher scores mean better","9 weeks",{"measure":14,"description":15,"timeFrame":16},"Adverse effects","Swedish short questionnaire (description) about adverse effects, 0-1, Higher scores are worse","Session 2 (2 weeks), session 6 (6 weeks), 9 weeks",{"measure":18,"description":19,"timeFrame":20},"Experienced impairment from OC symptoms, experienced change after the training program","Qualitative interviews","baseline, 9 weeks",{"measure":22,"description":23,"timeFrame":24},"Single-case study","Obsessive Compulsive Inventory (OCI\u002FchOCI-RP), 0-2, Higher scores mean worse","baseline, every second week (week 2, 4, 6, 8), 9 weeks",{"measure":10,"description":26,"timeFrame":27},"Study take-up: calculating the average number of included participants per week","baseline",{"measure":10,"description":29,"timeFrame":12},"How much the participant engage in the program (youth and parents): Number of training sessions per week, higher scores mean better",{"measure":10,"description":31,"timeFrame":12},"Post-treatment satisfaction assessed using items from the Client Satisfaction Questionnaire (CSQ): 0-4, higher scores mean better",[33,37],{"measure":34,"description":35,"timeFrame":36},"To evaluate whether the digital training program can change the intensity of the obsessions and compulsions","Children Yale brown Obsessive Compulsive Scale (CYBOCS), 0-4, higher scores mean worse","baseline, 9 weeks, 3 months",{"measure":34,"description":23,"timeFrame":38},"Baseline, 9 weeks, 3 months",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":46,"whoMasked":47},"SINGLE","Outcome assessors and data analysts are blinded. If assessor becomes unblinded, future assessments are conducted by another assessor.\n\nAll assessors are clinically qualified. All assessors are trained. A consensus discussion is available in case of uncertainty.",[48],"OUTCOMES_ASSESSOR","The training program was developed through a co-creation process involving children and adolescents with lived experience of OCD and who had previously completed a cognitive behavioural therapy (CBT) training program, as well as parents of children who had previously received therapeutic treatment for OCD.\n\nThe aim of the present clinical research project is to evaluate the feasibility and acceptability of the newly developed interactive digital training program for obsessive compulsive symptoms in children and adolescents, including two groups: limited versus regular digital therapist guidance in a randomized trial. The project expands evidence-based online assessment, which gives the possibility of developing a systematic target group definition, and conducting a systematic effectiveness evaluation of the digital training.\n\nSpecific objectives:\n\nTo examine feasibility and acceptability of the training program To evaluate the experienced effects of the training program in terms of the experienced symptom severity of obsessions and compulsions To evaluate the changes in children's and adolescent's well-being and distress over time To explore how the parents experience the supportive parent program\n\nStatistical procedures:\n\nSingle-case case analysis:\n\nThe design is a Multiple Baseline Design across individuals with a baseline evaluation (at primary evaluation), and another baseline evaluation before module 1 (within 1 to 3 weeks after primary evaluation), biweekly evaluations during training and evaluation after treatment.\n\nVisual analyses are used to determine whether there is a functional relation between the intervention and the outcome. If evidence for a functional effect, the visual analysis is supplemented with quantitative analysis methods evaluating the magnitude of the intervention effect. Effect sizes are combined across cases to estimate overall average intervention effects which contributes to evidence-based practice, theory, and future applications (doi: 10.1097\u002FNPT.0000000000000187)\n\nEfficacy analysis:\n\nThe analyses are performed in according to the intention-to-treat principle using a linear mixed-effect model with random effects for repeated measures with maximum likelihood estimation with the assumption that data were missing at random. The model includes fixed effects for group and time, as well as individuals' random intercept and random slope. The interaction effect of group-by-time will be used to evaluate group differences after treatment (at 9 weeks)\n\nQualitative interviews (semistructurered interviews) conducted prior to treatment will focus on children\u002Fadolescents' and parents' experiences of obsessive-compulsive symptoms, including perceived burden in daily life and perceived treatment needs. Post-treatment interviews will focus on perceived usability, usefulness, and satisfaction with the digital intervention, symptom change, adherence to the program, as well as perceived need for parental involvement and support. The interviews are analysed using the Reflexive Thematic Analysis which is a six-phase method that supports both the practical development of codes and a structured analytic process, thereby focusing on the interpretation and understanding of the underlying meanings within the data",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"Therapeut-assisted arm","ACTIVE_COMPARATOR","Participants are required to chat with the therapist during sessions 2 and 6 and have the option to chat with the therapist during all other weeks.",[56],"Behavioral: Digital behavioral training",{"label":58,"type":53,"description":59,"interventionNames":60},"Limited therapeut-assisted arm","Participants are required to chat with the therapist during sessions 2 and 6. They are not allowed to chat with the therapist during the other weeks",[56],[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":39},"BEHAVIORAL","Digital behavioral training","The program is structured into distinct sessions, through which children and adolescents are educated about obsessions and compulsions and provided with strategies for managing their symptoms. The primary objective is to equip participants with effective coping techniques. In parallel, parents are offered a supplementary treatment program designed to provide support in their involvement in the therapeutic process.\n\nBoth programs are online using videos, interactive materials and assignments for both the children\u002Fyouth and the parents.\n\nBoth intervention arms involve the same program. The only difference is the extent of therapist contact",[58,52],[68],{"name":69,"role":70,"phone":71,"phoneExt":72,"email":73},"Judith Becker Nissen, PhD, associate professor","CONTACT","21622339","0045","judiniss@rm.dk",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"PRINCIPAL_INVESTIGATOR","Judith Becker Nissen","PhD, Associate clinical professor, Senior doctor, Child and Adolescent Psychiatry",[79,82],{"name":80,"class":81},"Department of IT and Digitalization, AUH","UNKNOWN",{"name":83,"class":81},"Participating municipalities in Central Region Denmark","100659465","digital-oc-training-in-children-and-adolescents-100659465",false,"NCT07864675","Digital OC Training in Children and Adolescents","Evidence-Based Early Intervention for Children and Adolescents With Obsessive-Compulsive Symptoms - a Digital Treatment Program for Children and Adolescents, Supplemented by a Supportive Parent Program A Feasibility and Acceptability Study","DOT-Y","Inclusion Criteria: obsessions and compulsions -\n\nExclusion Criteria: Severe obsessive-compulsive symptoms (often requiring more intensive treatment and frequently referred to the hospital), suicidal thoughts or severe depression, severe anorexia, psychosis, clinical impression of intellectual disability, insufficient language skills.\n\n\\-","ALL","7 Years","17 Years",{"count":96,"type":97},20,"ESTIMATED","INTERVENTIONAL",[100],"NA","The project is an interventional trial that compares digital training programs with varying levels of therapeutic contact. All participating children and adolescents will receive a digital training program following a thorough online evaluation. Additionally, parents are invited to participate in an online, supportive parenting program designed to complement the digital treatment.",[103],"Obsessive Compulsive Behavior",[105,106,107,108,109],"obsession","compulsion","adolescent","children","digital","NOT_YET_RECRUITING","2026-10-02",{"date":113,"type":114},"2026-10-08","ACTUAL",{"date":116,"type":97},"2027-01-01",{"date":118,"type":97},"2030-11-01",{"name":5,"class":6}]