Courageous Parents, Courageous Children (COACH)

August 19, 2024 updated by: Nova Scotia Health Authority

Transgenerational Prevention of Anxiety in Children at Ultra-high Risk

Anxiety disorders usually start in childhood and adolescence and are associated with social and occupational difficulties in adulthood. Children who have a parent with an anxiety disorder and who find new situations distressing and avoid them are at an increased risk for developing an anxiety disorder. Research suggests that anti-anxiety parenting can help children grow up courageous and calm. It is, however, difficult to parent in an anti-anxiety way when the parent has an anxiety disorder himself or herself.

This research study will test the efficacy of a new program designed to prevent the onset or persistence of anxiety disorders in children at risk for anxiety disorders. The investigators will first help parents learn skills to cope with their own anxiety and then coach them to share these skills with their children and parent in an anti-anxiety way. The goal is to intervene early enough in the children's lives so that they can be free of anxiety disorders and lead happy, healthy and productive lives in adulthood.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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.
88

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B4E 0H4

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Parents:

Inclusion criteria:

Parents will be included if they have a current diagnosis of at least one anxiety disorder, one or more children between the ages two and eight years in their own care, capacity to provide informed consent, and ability to speak English well enough to benefit from the intervention.

Exclusion criteria:

Exclusion criteria for parents are receipt of an adequate course (6 or more sessions) of structured psychological therapy in the past 12 months, or plans to move out of Nova Scotia within the next three years. We will include parents with co-morbid mood disorders. However, those whose mood disorder is the primary complaint will be referred for treatment for their mood before being re-assessed. We will exclude parents with disorders that would interfere with the standard treatment protocol delivery; these include lifetime schizophrenia, autism, intellectual disability and current drug and alcohol use disorder.

Offspring:

Inclusion criteria:

Children are eligible if they are aged two to eight and if they have a score of inhibited temperament (negative emotionality) one standard deviation or more above the mean of an age-matched normative sample on the Laboratory Assessment of Temperament.

Exclusion criteria:

Those with lifetime schizophrenia, autism, general intellectual disability, and current drug and alcohol addiction will be excluded, as these conditions would impact on the standard delivery of the parenting intervention. We will exclude children currently receiving treatment for anxiety.

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: Prevention
  • 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: Cognitive behavioural skills training
Behavioral: Cognitive behavioural skills training
The intervention will be delivered in two stages: First, the parent with an anxiety disorder will attend between six and sixteen weekly sessions of cognitive behavioural skills training focusing on their own anxiety. They will work on developing behaviours that will help them become less anxious in the long-run and on learning to evaluate danger in a realistic way. Next, the parent will take part in four to eight weekly sessions of anti-anxiety parenting skills training aiming to help them transfer the skills that they learned into parenting their children. In the parenting intervention, the parents will be guided to gradually expose their children to new situations, build communication skills and confidence, in addition to general parenting skills and principles.
No Intervention: No intervention
Participants in the control group will receive their usual clinical care and will not be discouraged from seeking any intervention.

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
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time Frame: One year post randomization
Diagnosis of anxiety disorder in the offspring
One year post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time Frame: Two years post randomization
Diagnosis of anxiety disorder in the offspring
Two years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time Frame: Three years post randomization
Diagnosis of anxiety disorder in the offspring
Three years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time Frame: Five years post randomization
Diagnosis of anxiety disorder in the offspring
Five years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time Frame: Seven years post randomization
Diagnosis of anxiety disorder in the offspring
Seven years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time Frame: Ten years post randomization
Diagnosis of anxiety disorder in the offspring
Ten years post randomization

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
Teaching Task Battery
Time Frame: One year post randomization
Parenting behaviours
One year post randomization
Teaching Task Battery
Time Frame: Two years post randomization
Parenting behaviours
Two years post randomization
Structured Clinical Interview for DSM-5 diagnoses (SCID-5)
Time Frame: One year post randomization
Diagnosis of anxiety disorder in the parent
One year post randomization
Structured Clinical Interview for DSM-5 diagnoses (SCID-5)
Time Frame: Two years post randomization
Diagnosis of anxiety disorder in the parent
Two years post randomization
Laboratory Temperament Assessment Battery
Time Frame: One year post randomization
Temperament in the offspring
One year post randomization
Laboratory Temperament Assessment Battery
Time Frame: Two years post randomization
Temperament in the offspring
Two years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time Frame: Three years post randomization
Diagnosis of major mood and psychotic disorders in offspring
Three years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time Frame: Five years post randomization
Diagnosis of major mood and psychotic disorders in offspring
Five years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time Frame: Seven years post randomization
Diagnosis of major mood and psychotic disorders in offspring
Seven years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time Frame: Ten years post randomization
Diagnosis of major mood and psychotic disorders in offspring
Ten years post randomization
Global Assessment of Functioning
Time Frame: One year post randomization
Functioning in the offspring
One year post randomization
Global Assessment of Functioning
Time Frame: Two years post randomization
Functioning in the offspring
Two years post randomization
Global Assessment of Functioning
Time Frame: Three years post randomization
Functioning in the offspring
Three years post randomization
Global Assessment of Functioning
Time Frame: Five years post randomization
Functioning in the offspring
Five years post randomization
Global Assessment of Functioning
Time Frame: Seven years post randomization
Functioning in the offspring
Seven years post randomization
Global Assessment of Functioning
Time Frame: Ten years post randomization
Functioning in the offspring
Ten years post randomization
Screen for Child Anxiety Related Disorders
Time Frame: One year post randomization
Anxiety in the offspring - continuous
One year post randomization
Screen for Child Anxiety Related Disorders
Time Frame: Two years post randomization
Anxiety in the offspring - continuous
Two years post randomization
Screen for Child Anxiety Related Disorders
Time Frame: Three years post randomization
Anxiety in the offspring - continuous
Three years post randomization
Screen for Child Anxiety Related Disorders
Time Frame: Five years post randomization
Anxiety in the offspring - continuous
Five years post randomization
Screen for Child Anxiety Related Disorders
Time Frame: Seven years post randomization
Anxiety in the offspring - continuous
Seven years post randomization
Screen for Child Anxiety Related Disorders
Time Frame: Ten years post randomization
Anxiety in the offspring - continuous
Ten years post randomization
Spence Children's Anxiety Scale
Time Frame: One year post randomization
Anxiety in the offspring - continuous
One year post randomization
Spence Children's Anxiety Scale
Time Frame: Two years randomization
Anxiety in the offspring - continuous
Two years randomization
Spence Children's Anxiety Scale
Time Frame: Three years post randomization
Anxiety in the offspring - continuous
Three years post randomization
Spence Children's Anxiety Scale
Time Frame: Five years post randomization
Anxiety in the offspring - continuous
Five years post randomization

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.
Nova Scotia Health Authority

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.
September 17, 2017

Primary Completion (Estimated)

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.
September 1, 2025

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.
September 1, 2025

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).
July 18, 2017

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 19, 2017

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 21, 2017

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.
August 21, 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.
August 19, 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.
August 1, 2024

More Information

Terms related to this study

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.
  • 1022588

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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