Anxiety Disorder Clinical Trial
— COACHOfficial 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.
Status | Not yet recruiting |
Enrollment | 88 |
Est. completion date | September 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Barbara Pavlova |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) | Diagnosis of anxiety disorder in the offspring | One year post randomization | |
Primary | Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) | Diagnosis of anxiety disorder in the offspring | Two years post randomization | |
Primary | Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) | Diagnosis of anxiety disorder in the offspring | Three years post randomization | |
Primary | Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) | Diagnosis of anxiety disorder in the offspring | Five years post randomization | |
Primary | Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) | Diagnosis of anxiety disorder in the offspring | Seven years post randomization | |
Primary | Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) | Diagnosis of anxiety disorder in the offspring | Ten years post randomization | |
Secondary | Teaching Task Battery | Parenting behaviours | One year post randomization | |
Secondary | Teaching Task Battery | Parenting behaviours | Two years post randomization | |
Secondary | Structured Clinical Interview for DSM-5 diagnoses (SCID-5) | Diagnosis of anxiety disorder in the parent | One year post randomization | |
Secondary | Structured Clinical Interview for DSM-5 diagnoses (SCID-5) | Diagnosis of anxiety disorder in the parent | Two years post randomization | |
Secondary | Laboratory Temperament Assessment Battery | Temperament in the offspring | One year post randomization | |
Secondary | Laboratory Temperament Assessment Battery | Temperament in the offspring | Two years post randomization | |
Secondary | Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) | Diagnosis of major mood and psychotic disorders in offspring | Three years post randomization | |
Secondary | Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) | Diagnosis of major mood and psychotic disorders in offspring | Five years post randomization | |
Secondary | Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) | Diagnosis of major mood and psychotic disorders in offspring | Seven years post randomization | |
Secondary | Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) | Diagnosis of major mood and psychotic disorders in offspring | Ten years post randomization | |
Secondary | Global Assessment of Functioning | Functioning in the offspring | One year post randomization | |
Secondary | Global Assessment of Functioning | Functioning in the offspring | Two years post randomization | |
Secondary | Global Assessment of Functioning | Functioning in the offspring | Three years post randomization | |
Secondary | Global Assessment of Functioning | Functioning in the offspring | Five years post randomization | |
Secondary | Global Assessment of Functioning | Functioning in the offspring | Seven years post randomization | |
Secondary | Global Assessment of Functioning | Functioning in the offspring | Ten years post randomization | |
Secondary | Screen for Child Anxiety Related Disorders | Anxiety in the offspring - continuous | One year post randomization | |
Secondary | Screen for Child Anxiety Related Disorders | Anxiety in the offspring - continuous | Two years post randomization | |
Secondary | Screen for Child Anxiety Related Disorders | Anxiety in the offspring - continuous | Three years post randomization | |
Secondary | Screen for Child Anxiety Related Disorders | Anxiety in the offspring - continuous | Five years post randomization | |
Secondary | Screen for Child Anxiety Related Disorders | Anxiety in the offspring - continuous | Seven years post randomization | |
Secondary | Screen for Child Anxiety Related Disorders | Anxiety in the offspring - continuous | Ten years post randomization | |
Secondary | Spence Children's Anxiety Scale | Anxiety in the offspring - continuous | One year post randomization | |
Secondary | Spence Children's Anxiety Scale | Anxiety in the offspring - continuous | Two years randomization | |
Secondary | Spence Children's Anxiety Scale | Anxiety in the offspring - continuous | Three years post randomization | |
Secondary | Spence Children's Anxiety Scale | Anxiety in the offspring - continuous | Five years post randomization |
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