Anxiety DisorderCOACHNCT03224845
Courageous Parents, Courageous Children
A study testing Cognitive behavioural skills training in people with Anxiety Disorder, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anxiety Disorder
- What is being tested?
- Cognitive behavioural skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- 17 Sep 2017to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Nova Scotia Health
Halifax, Nova Scotia, B4E 0H4
Jill Cumby, 902-473-1781, jill.cumby@nshealth.ca
About this study
Official title: 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.
- Conditions
- Anxiety Disorder
- Being tested
- Cognitive behavioural skills training
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural skills trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioural skills training | Experimental | Not described Receives: Behavioral: Cognitive behavioural skills training |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Measured: One year post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Measured: Two years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Measured: Three years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Measured: Five years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Measured: Seven years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Measured: Ten years post randomization
Secondary outcomes (26)
Teaching Task Battery
Parenting behaviours
Measured: One year post randomization
Teaching Task Battery
Parenting behaviours
Measured: Two years post randomization
Structured Clinical Interview for DSM-5 diagnoses (SCID-5)
Diagnosis of anxiety disorder in the parent
Measured: One year post randomization
Structured Clinical Interview for DSM-5 diagnoses (SCID-5)
Diagnosis of anxiety disorder in the parent
Measured: Two years post randomization
Laboratory Temperament Assessment Battery
Temperament in the offspring
Measured: One year post randomization
Laboratory Temperament Assessment Battery
Temperament in the offspring
Measured: Two years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of major mood and psychotic disorders in offspring
Measured: Three years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of major mood and psychotic disorders in offspring
Measured: Five years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of major mood and psychotic disorders in offspring
Measured: Seven years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of major mood and psychotic disorders in offspring
Measured: Ten years post randomization
Global Assessment of Functioning
Functioning in the offspring
Measured: One year post randomization
Global Assessment of Functioning
Functioning in the offspring
Measured: Two years post randomization
Global Assessment of Functioning
Functioning in the offspring
Measured: Three years post randomization
Global Assessment of Functioning
Functioning in the offspring
Measured: Five years post randomization
Global Assessment of Functioning
Functioning in the offspring
Measured: Seven years post randomization
Global Assessment of Functioning
Functioning in the offspring
Measured: Ten years post randomization
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Measured: One year post randomization
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Measured: Two years post randomization
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Measured: Three years post randomization
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Measured: Five years post randomization
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Measured: Seven years post randomization
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Measured: Ten years post randomization
Spence Children's Anxiety Scale
Anxiety in the offspring - continuous
Measured: One year post randomization
Spence Children's Anxiety Scale
Anxiety in the offspring - continuous
Measured: Two years randomization
Spence Children's Anxiety Scale
Anxiety in the offspring - continuous
Measured: Three years post randomization
Spence Children's Anxiety Scale
Anxiety in the offspring - continuous
Measured: Five years post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start17 Sep 2017
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224845
- Sponsor's protocol ID
- 1022588
- Acronym
- COACH
- Status last verified
- Aug 2024
- First submitted
- 18 Jul 2017
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transgenerational Prevention of Anxiety in Children at Ultra-high Risk
- ClinicalTrials.gov ID
- NCT03224845
- Acronym / sponsor ID
- COACH / 1022588
- Conditions
- Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 17 Sep 2017 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioural skills training | Experimental | Behavioral: Cognitive behavioural skills training |
| No intervention | No intervention | –Participants in the control group will receive their usual clinical care and will not be discouraged from seeking any intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- 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.
Key exclusion criteria (3 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioural skills trainingThe 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. | Behavioural | Cognitive behavioural skills training |
Primary outcome
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time frame: One year post randomization
Diagnosis of anxiety disorder in the offspring
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time frame: Two years post randomization
Diagnosis of anxiety disorder in the offspring
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time frame: Three years post randomization
Diagnosis of anxiety disorder in the offspring
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time frame: Five years post randomization
Diagnosis of anxiety disorder in the offspring
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time frame: Seven years post randomization
Diagnosis of anxiety disorder in the offspring
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time frame: Ten years post randomization
Diagnosis of anxiety disorder in the offspring
26 secondary outcomes
Teaching Task Battery
Time frame: One year post randomization
Teaching Task Battery
Time frame: Two years post randomization
Structured Clinical Interview for DSM-5 diagnoses (SCID-5)
Time frame: One year post randomization
Structured Clinical Interview for DSM-5 diagnoses (SCID-5)
Time frame: Two years post randomization
Laboratory Temperament Assessment Battery
Time frame: One year post randomization
Laboratory Temperament Assessment Battery
Time frame: Two years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time frame: Three years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time frame: Five years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time frame: Seven years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Time frame: Ten years post randomization
Global Assessment of Functioning
Time frame: One year post randomization
Global Assessment of Functioning
Time frame: Two years post randomization
Global Assessment of Functioning
Time frame: Three years post randomization
Global Assessment of Functioning
Time frame: Five years post randomization
Global Assessment of Functioning
Time frame: Seven years post randomization
Global Assessment of Functioning
Time frame: Ten years post randomization
Screen for Child Anxiety Related Disorders
Time frame: One year post randomization
Screen for Child Anxiety Related Disorders
Time frame: Two years post randomization
Screen for Child Anxiety Related Disorders
Time frame: Three years post randomization
Screen for Child Anxiety Related Disorders
Time frame: Five years post randomization
Screen for Child Anxiety Related Disorders
Time frame: Seven years post randomization
Screen for Child Anxiety Related Disorders
Time frame: Ten years post randomization
Spence Children's Anxiety Scale
Time frame: One year post randomization
Spence Children's Anxiety Scale
Time frame: Two years randomization
Spence Children's Anxiety Scale
Time frame: Three years post randomization
Spence Children's Anxiety Scale
Time frame: Five years post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural skills training in people with Anxiety Disorder, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Pavlova, PhD DClinPsy RPsych (902 473 2585, barbara.pavlova@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) (time frame: One year post randomization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.