Courageous Parents, Courageous Children

Study Overview
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Brief Summary
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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.

Official Title
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Transgenerational Prevention of Anxiety in Children at Ultra-high Risk

Conditions
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Anxiety Disorder

Intervention / Treatment
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* Behavioral: Cognitive behavioural skills training


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavioural skills training<br> | Behavioral: Cognitive behavioural skills training<br>* 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.<br>|
| No Intervention: No intervention<br>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?
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Primary Outcome Measures

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

Secondary Outcome Measures

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