Back to resultsCourageous Parents, Courageous Children (COACH)
Primary Purpose
Anxiety Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive behavioural skills training
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety Disorder
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cognitive behavioural skills training
No intervention
Arm Description
Participants in the control group will receive their usual clinical care and will not be discouraged from seeking any intervention.
Outcomes
Primary Outcome Measures
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Secondary Outcome Measures
Teaching Task Battery
Parenting behaviours
Teaching Task Battery
Parenting behaviours
Structured Clinical Interview for DSM-5 diagnoses (SCID-5)
Diagnosis of anxiety disorder in the parent
Structured Clinical Interview for DSM-5 diagnoses (SCID-5)
Diagnosis of anxiety disorder in the parent
Laboratory Temperament Assessment Battery
Temperament in the offspring
Laboratory Temperament Assessment Battery
Temperament in the offspring
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of major mood and psychotic disorders in offspring
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of major mood and psychotic disorders in offspring
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of major mood and psychotic disorders in offspring
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of major mood and psychotic disorders in offspring
Global Assessment of Functioning
Functioning in the offspring
Global Assessment of Functioning
Functioning in the offspring
Global Assessment of Functioning
Functioning in the offspring
Global Assessment of Functioning
Functioning in the offspring
Global Assessment of Functioning
Functioning in the offspring
Global Assessment of Functioning
Functioning in the offspring
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Spence Children's Anxiety Scale
Anxiety in the offspring - continuous
Spence Children's Anxiety Scale
Anxiety in the offspring - continuous
Spence Children's Anxiety Scale
Anxiety in the offspring - continuous
Spence Children's Anxiety Scale
Anxiety in the offspring - continuous
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03224845
Brief Title
Courageous Parents, Courageous Children
Acronym
COACH
Official Title
Transgenerational Prevention of Anxiety in Children at Ultra-high Risk
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Barbara Pavlova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavioural skills training
Arm Type
Experimental
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Participants in the control group will receive their usual clinical care and will not be discouraged from seeking any intervention.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioural skills training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Description
Diagnosis of anxiety disorder in the offspring
Time Frame
One year post randomization
Title
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Description
Diagnosis of anxiety disorder in the offspring
Time Frame
Two years post randomization
Title
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Description
Diagnosis of anxiety disorder in the offspring
Time Frame
Three years post randomization
Title
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Description
Diagnosis of anxiety disorder in the offspring
Time Frame
Five years post randomization
Title
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Description
Diagnosis of anxiety disorder in the offspring
Time Frame
Seven years post randomization
Title
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Description
Diagnosis of anxiety disorder in the offspring
Time Frame
Ten years post randomization
Secondary Outcome Measure Information:
Title
Teaching Task Battery
Description
Parenting behaviours
Time Frame
One year post randomization
Title
Teaching Task Battery
Description
Parenting behaviours
Time Frame
Two years post randomization
Title
Structured Clinical Interview for DSM-5 diagnoses (SCID-5)
Description
Diagnosis of anxiety disorder in the parent
Time Frame
One year post randomization
Title
Structured Clinical Interview for DSM-5 diagnoses (SCID-5)
Description
Diagnosis of anxiety disorder in the parent
Time Frame
Two years post randomization
Title
Laboratory Temperament Assessment Battery
Description
Temperament in the offspring
Time Frame
One year post randomization
Title
Laboratory Temperament Assessment Battery
Description
Temperament in the offspring
Time Frame
Two years post randomization
Title
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Description
Diagnosis of major mood and psychotic disorders in offspring
Time Frame
Three years post randomization
Title
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Description
Diagnosis of major mood and psychotic disorders in offspring
Time Frame
Five years post randomization
Title
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Description
Diagnosis of major mood and psychotic disorders in offspring
Time Frame
Seven years post randomization
Title
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Description
Diagnosis of major mood and psychotic disorders in offspring
Time Frame
Ten years post randomization
Title
Global Assessment of Functioning
Description
Functioning in the offspring
Time Frame
One year post randomization
Title
Global Assessment of Functioning
Description
Functioning in the offspring
Time Frame
Two years post randomization
Title
Global Assessment of Functioning
Description
Functioning in the offspring
Time Frame
Three years post randomization
Title
Global Assessment of Functioning
Description
Functioning in the offspring
Time Frame
Five years post randomization
Title
Global Assessment of Functioning
Description
Functioning in the offspring
Time Frame
Seven years post randomization
Title
Global Assessment of Functioning
Description
Functioning in the offspring
Time Frame
Ten years post randomization
Title
Screen for Child Anxiety Related Disorders
Description
Anxiety in the offspring - continuous
Time Frame
One year post randomization
Title
Screen for Child Anxiety Related Disorders
Description
Anxiety in the offspring - continuous
Time Frame
Two years post randomization
Title
Screen for Child Anxiety Related Disorders
Description
Anxiety in the offspring - continuous
Time Frame
Three years post randomization
Title
Screen for Child Anxiety Related Disorders
Description
Anxiety in the offspring - continuous
Time Frame
Five years post randomization
Title
Screen for Child Anxiety Related Disorders
Description
Anxiety in the offspring - continuous
Time Frame
Seven years post randomization
Title
Screen for Child Anxiety Related Disorders
Description
Anxiety in the offspring - continuous
Time Frame
Ten years post randomization
Title
Spence Children's Anxiety Scale
Description
Anxiety in the offspring - continuous
Time Frame
One year post randomization
Title
Spence Children's Anxiety Scale
Description
Anxiety in the offspring - continuous
Time Frame
Two years randomization
Title
Spence Children's Anxiety Scale
Description
Anxiety in the offspring - continuous
Time Frame
Three years post randomization
Title
Spence Children's Anxiety Scale
Description
Anxiety in the offspring - continuous
Time Frame
Five years post randomization
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Pavlova, PhD DClinPsy RPsych
Phone
902 473 2585
Email
barbara.pavlova@dal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Cumby, RN
Phone
902 473 1781
Email
jill.cumby@nshealth.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Courageous Parents, Courageous Children
We'll reach out to this number within 24 hrs