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

July 3, 2024 updated by: Anne Katrine Pagsberg
To investigate the benefits and harms, and the neural and neurocognitive mediators of treatment response, in family-based cognitive behavioural therapy versus family-based psychoeducation and relaxation training in children and adolescents with obsessive compulsive disorder. The aim is to conduct this investigation in an optimal trial design with the lowest possible risk of bias.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Obsessive-compulsive disorder is the fourth most common psychiatric disorder, affecting 1-3% of children and adolescents globally. The recommended first-line treatment is cognitive behavioral therapy with exposure and response prevention. Yet, more than 40% of patients do not, or only partially, benefit from therapy. A better understanding of the mechanisms underlying response to cognitive behavioral therapy is needed to improve treatment. In the TECTO study, we will conduct a combined randomized clinical trial and longitudinal case-control study to elucidate how neural, cognitive, emotional, and neuroendocrine factors moderate and mediate treatment response. At baseline, 128 children and adolescents with obsessive-compulsive disorder will be compared to 128 healthy control participants to map neurobiological, cognitive, and emotional markers of obsessive-compulsive disorder. After baseline assessment, patients are randomly assigned to 16 weeks of either cognitive behavioral therapy with exposure and response prevention or an active control treatment with psychoeducation and relaxation training. This design allows us to test how factors that are specific to cognitive behavioral therapy (e.g. exposure and response prevention) contribute to observed treatment effects. Our primary outcome is OCD symptom severity measured with the Children's Yale-Brown Obessive-Compulsive Scale. Secondary outcomes are health-related quality of life and negative treatment effects. To detect neural and cognitive mediators of treatment, we will measure brain structure and function, and cognitive performance, at baseline and end-of-treatment. Furthermore, we will monitor a range of therapeutic, emotional, family, and neuroendocrine factors before, during, and after treatment. We expect that findings from TECTO will have important theoretical implications and will help refine our understanding of OCD as a heterogeneous and multidimensional disorder. Finally, we expect that our findings will contribute significantly to the improvement of psychotherapy and development of more targeted interventions for pediatric obsessive-compulsive disorder, which can minimize the use of medication, prevent chronicity, and reduce the substantial socioeconomic burden of the disorder.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Child and Adolescent Mental Health Centre, Bispebjerg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • OCD diagnosis as primary diagnosis, meeting the criteria for International Classification of Diseases 10 (ICD-10) F42, verified with a semi-structured psychopathological interview using Schedule for Affective Disorders and Schizophrenia for school-aged children, Present and Lifetime version (K-SADS-PL).
  • Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) entry score ≥16, a cut-off score used in previous studies.
  • Age 8 through 17 years (both inclusive).
  • Signed informed consent.

Exclusion Criteria:

  • Comorbid illness that contraindicates trial participation: pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9), schizophrenia/paranoid psychosis (ICD-10 F20-25 + F28-29), mania or bipolar disorder (ICD-10 F30 and F31), depressive psychotic disorders (F32.3 + F33.3), substance dependence syndrome (ICD-10 F1x.2).
  • Intelligence Quotient <70.
  • Treatment with Cognitive Behavioural Therapy (CBT), Serotonin Reuptake Inhibitors, or other antidepressant medication or antipsychotic medication within the last 6 months prior to trial entry.

  • For MRI-scanning:

    • metal braces on teeth or metal implants;
    • any known brain pathology;
    • history of severe head-trauma (ICD-10 S6-S9);
    • pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FCBT
The Family Based Cognitive Behavioural Therapy (FCBT)
Behavioral: Family Based Cognitive Behavioural Therapy
Family Based Cognitive Behavioural Therapy (FCBT) focuses on the interrelation between thought, emotion, and behaviour, Exposure and Response Prevention, family involvement, homework assignments, and formulating of specific goals for the child. The important, active components is Exposure and Response Prevention. It involves exposing the child to a feared object, situation or thought, and preventing the child from carrying out compulsions to show the child that distress/anxiety can decrease or disappear without performing rituals.
Active Comparator: FPRT
Family-based Psychoeducation /Relaxation Training (FPRT)
Behavioral: Family Based Psychoeducation/Relaxation Training
Family-based Psychoeducation/Relaxation Training (FPRT) as an active control matches the experimental intervention as closely as possible, many elements of the control intervention are similar to FCBT. The main and intended difference between the two approaches is the absence of the Exposure and Response Prevention component, which is deemed the most effective treatment for OCD.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score
Time Frame: Week 0, 4, 8, 16 and 40
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) is a 10-item questionnaire assessing the severity of obsessive compulsive disorder (OCD). Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.
Week 0, 4, 8, 16 and 40

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
health-related quality of life assesses with KIDSCREEN-52
Time Frame: Week 0, 4, 8, 16 and 40
The KIDSCREEN instruments assess children's and adolescents' subjective health and well-being- health-related quality of life (HRQoL). Questionnaire consisted of 52 items which assessed HRQoL in 10 dimensions: physical well-being, psychological well-being, moods and emotions, self perception, autonomy, relation with parents and home life, social support and peers, school environment, social acceptance, and financial resources. Rasch scores are computed for each dimension and are transformed into T-values with a mean of 50 and a standard deviation of 10; higher scores indicate better HRQoL and well-being.
Week 0, 4, 8, 16 and 40
Occurrence of negative adverse events
Time Frame: Week 4, 8, 16 and 40
The occurrence of negative adverse events is assessed with the Negative Effects Questionnaire (NEQ). The questionnaire is used for both parental reports and self-reports. It consists of 32 items that are scored on a five-point Likert-scale (0-4) where the highest value represents a severe negative effect of the event. The questionnaire differentiates between negative effects that are attributed to the treatment and those possibly caused by other circumstances, as well as one open-ended question.
Week 4, 8, 16 and 40

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Magnetic resonance imaging
Time Frame: Week 0 and 16
This is exploratory outcome. Magnetic resonance imaging (MRI) is used to obtain images of the patients' brains before and after treatment and the scanning consists of both structural and functional scans. From the functional scans response-inhibition-related and switch-related activity during Stop Signal Task performance and Task Switching performance is examined.
Week 0 and 16
Family Accommodation Scale
Time Frame: Week 4, 8, 16 and 40
This is exploratory outcome showing family factors. Family Accommodation Scale (FAS): a 13-item parent-report measure designed to assess accommodation of a child's OCD-related behaviors over the previous month. In an effort to assess multiple dimensions to accommodations (rather than one in isolation), items are anchored with respect to either frequency or magnitude utilizing a 5-pt Likert scale ranging from 0 (Never) to 4 (Daily) with higher scores indicating greater parental accommodation.
Week 4, 8, 16 and 40
Family Environment Scale
Time Frame: Week 0
This is exploratory outcome showing family factors. Family Environment Scale (FES)is composed of 90 items and 10 subscales that measure actual, preferred, and expected family social environments. The 10 subscales assess three dimensions: relationship dimensions, personal growth (or goal orientation) dimensions, and system maintenance dimensions. There are three FES forms (real, ideal, and expectations); only the FES real form will be used, which examines a family member's perception of the family as it is. The scale ranges from 10 to 40, with a score of 10 being representative of no family conflict and a score of 40 being representative of the greatest magnitude of family conflict. Therefore, a decrease in score represents a decrease in self-reported family conflict.
Week 0
Parental Stress Scale
Time Frame: Week 4, 8, 16 and 40
This is exploratory outcome showing family factors. Parental Stress Scale (PSS)measures parental stress in the parental relationship and consists of 18 items. The parent answers different statements about his or her relationship to the child by scoring each item on a five-point Likert-scale (1-5), 5 representing the highest amount of agreement with the statement and 1 representing the highest amount of dis-agreement. The positively formulated items are scored in reverse. PSS is thus scored on a scale from 18 to 90, where higher scores reflect greater stress.
Week 4, 8, 16 and 40
Child Obsessive-Compulsive Impact Scale
Time Frame: Week 4, 8, 16 and 40
This is exploratory clinical outcome.Child Obsessive-Compulsive Impact Scale (COIS) is a 33-item parent-report and self-report questionnaire that assesses OCD-related impairment in various areas of the child's life, including school, social, and home/family activities. For each item, the respondent rates the child's level of impairment on a 4-point Likert scale from 0 (not at all) to 3 (very much). The total score (0-99) is the sum of the item scores. Higher scores reflect more severe impairment.
Week 4, 8, 16 and 40
Clinical Global Impression Severity and Clinical Global Impression Improvement Scale
Time Frame: Week 4, 8, 16 and 40
This is exploratory clinical outcome. Clinical Global Impression Severity and Clinical Global Impression Improvement Scale (CGI-I and CGI-S) measure symptom severity, treatment response, and the efficacy of treatments in treatment studies of patients with mental disorders. Therefore higher scores indicate a worse mental state of the patient. The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-I scores range from 1 (very much improved) through to 7 (very much worse).
Week 4, 8, 16 and 40
Occurrence of Serious Adverse Events
Time Frame: Week 0-Week 40
This is exploratory clinical outcome. Occurrence of Serious Adverse Events.Any adverse events such as results in death, is life-threatening, requires hospitalisation or prolongs existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect, which does not necessarily have a causal relationship with the intervention will be registered register.
Week 0-Week 40
Children's Global Assessment Scale
Time Frame: Week 4, 8, 16 and 40
This is exploratory clinical outcome. Children's Global Assessment Scale Scale is a numeric scale used by mental health clinicians to rate the general functioning of youths under the age of 18. It is the 100-point single-item score, scored from 0-100 (worse to normal).
Week 4, 8, 16 and 40
Remission
Time Frame: Week 16
This is exploratory clinical outcome. Proportion of patients no longer meeting the diagnostic criteria for OCD, ICD-10 F.42 assessed with Schedule for Affective Disorders and Schizophrenia for school-aged children, Present and Lifetime version (K-SADS-PL) at the end of the intervention (remission).
Week 16
OCD symptoms remission
Time Frame: Week 16
This is exploratory clinical outcome.This is a binary, exploratory, clinical outcome. Treatment response based on the definition of a reduction in CY-BOCS score at week 16 of at least 30% in intraindividual comparison with the score at week 0.
Week 16
Toronto Obsessive-Compulsive Rating Scale
Time Frame: Week 0 and week 16
This is an exploratory clinical outcome. Toronto Obsessive-Compulsive Rating Scale (TOCS) is a quantitative and multidimensional measure of Obsessive-Compulsive traits in children and adolescents. Questionnaire with 21 items, and each item is scored on a 7-point likert scale from -3 to 3. Dimension scores ranges from -3 to 3. The total scale ranges from -63 to 63. Higher values represents worse outcome.
Week 0 and week 16
Risk taking and decision-making ability
Time Frame: Week 0 and week 16th
This is exploratory cognition outcome. Risk taking and decision-making assessed by Cambridge Gambling Task
Week 0 and week 16th
Planning ability
Time Frame: Week 0 and week 16th
This is exploratory cognition outcome. Planning ability assessed by Stockings of Cambridge test. It is a computerized neuropsychological test assessing executive functions. There are two main outcomes: Reaction time and accuracy. Low reaction time combined with high accuracy represents better planning ability.
Week 0 and week 16th
Working memory capacity
Time Frame: Week 0 and week 16th
This is exploratory cognition outcome. Working memory capacity assessed by Spatial Working Memory test. It requires retention and manipulation of visuospatial information. This self-ordered test has notable executive function demands and provides a measure of strategy as well as working memory errors. Reaction time and accuracy. Low reaction time combined with high accuracy represents better memory capacity.
Week 0 and week 16th
Motor skills
Time Frame: Week 0 and week 16th
This is an exploratory cognition outcome. Motor skills assessed with Purdue Pegboard test. It controls for potential effects of differences in motor skills on performance on other tasks in the battery. Test is a rectangular board with 2 sets of 25 holes running vertically and 4 concave cups at the top. Small metal pegs are placed in the cup on the side being tested, with subjects asked to remove the pegs and place them vertically in the holes as rapidly as possible. The number of pegs placed in 30 seconds is scored. More accurate placed pegs represent better motor skills.
Week 0 and week 16th
Habit formation
Time Frame: Week 0 and week 16th
This is exploratory cognition outcome. Weather Prediction Learning Task, which is a probabilistic classification learning task in which participants learn to predict the weather (i.e. "sun" or "rain" outcomes) based on combinations of cues that predict "sun" versus "rain" outcomes. Better prediction mean better outcome.
Week 0 and week 16th
Change in Delis-Kaplan Executive Function System (D-KEFS)
Time Frame: Week 0 and week 16th
This is an exploratory cognition outcome.The Delis-Kaplan Executive Function System (DKEFS). Test three tests from D-KEFS will be used: Trail Making, Verbal Fluency, and Design Fluency. The three test measures set-shifting ability, processing speed, and response inhibition. Each test has a scaled score going from 1-19, where higher values represent better outcome.
Week 0 and week 16th
Change in Thought-Action Fusion Questionnaire for Adolescents
Time Frame: Week 0, 4, 8, 16 and 40
This is exploratory outcome. Thought-Action Fusion Questionnaire for Adolescents (TAFQ-A): a 15-item questionnaire measuring cognitive biases that are thought to play an important role in the development of obsessions. Each item is scored on a 4-point likert scale from 1-4, were higher values represent worse outcome.
Week 0, 4, 8, 16 and 40
Executive function
Time Frame: Week 0 and week 16
This is exploratory outcome. Behaviour Rating Inventory of Executive Function: a self-report and parent-report questionnaire assessing impairment of executive function. Executive function in daily life (range:70-210). Higher score indicate greater executive dysfunction.
Week 0 and week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anne Katrine Pagsberg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Copenhagen Trial Unit, Center for Clinical Intervention Research
Danish Research Centre for Magnetic Resonance

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anne Katrine Pagsberg, Professor, Child and Adolescent Mental Health Centre, Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 7, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TECTO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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