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Trial reportTrials2022

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.

Markus Harboe Olsen, Julie Hagstrøm, Nicole Nadine Lønfeldt, Camilla Uhre, Valdemar Uhre, Linea Pretzmann, Sofie Heidenheim Christensen, Christine Thoustrup, Nicoline Løcke Jepsen Korsbjerg, Anna-Rosa Cecilie Mora-Jensen and 15 more

Registry-linked trialAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03595098 (Treatment Effects of Family Based Cognitive Therapy in Children and Adolescents With Obsessive Compulsive Disorder), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03595098 naactive not recruitingnot on this map

Treatment Effects of Family Based Cognitive Therapy in Children and Adolescents With Obsessive Compulsive Disorder

TypeinterventionalSponsorAnne Katrine PagsbergRan2018 to 2027Enrolled128ConditionsObsessive-Compulsive Disorder in Children, Obsessive-Compulsive Disorder in AdolescenceArmsFamily Based Cognitive Behavioural Therapy, Family Based Psychoeducation/Relaxation Training
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Markus Harboe OlsenCopenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. oel@oelfam.com.ORCID http://orcid.org/0000-0003-0981-0723
Julie HagstrømChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Nicole Nadine LønfeldtChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Camilla UhreChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Valdemar UhreChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Linea PretzmannChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Sofie Heidenheim ChristensenChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Christine ThoustrupChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Nicoline Løcke Jepsen KorsbjergChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Anna-Rosa Cecilie Mora-JensenChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Melanie RitterChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Janus EngstrømCopenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Jane LindschouCopenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Hartwig Roman SiebnerDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Frank VerhulstChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Pia JeppesenChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Jens Richardt Møllegaard JepsenChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Signe VangkildeChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Per Hove ThomsenDepartment of Child and Adolescent Psychiatry, Aarhus University Hospital, Aarhus, Denmark.
Katja HybelDepartment of Child and Adolescent Psychiatry, Aarhus University Hospital, Aarhus, Denmark.
Line Katrine Harder ClemmesenApplied Mathematics and Computer Science, Technical University of Denmark, Kgs Lyngby, Denmark.
Christian GluudCopenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Kerstin Jessica PlessenChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Anne Katrine PagsbergChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Copenhagen, Denmark.
Janus Christian JakobsenCopenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.

Funding

Friedrich Wilhelm Frank og hustru Angelina Franks Mindelegat 20006-1951Gangstedfonden A29811Lundbeckfonden R191-2015-922Lundbeckfonden R211-2015-3990
6 · The paper itself

Abstract

backgroundObsessive-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.

methodsThe 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 registrationClinicalTrials.gov NCT03595098. July 23, 2018.

Indexed as

Cognitive Behavioral TherapyObsessive-Compulsive DisorderAdolescentChildFamily TherapyHumansQuality of LifeRelaxation TherapyTreatment OutcomeCognitive behavioural therapyFamily-based psychoeducation/relaxation trainingObsessive-compulsive disorderRandomised clinical trialStatistical analysis plan

Identifiers

PMID36203215
PMCPMC9535232

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.