Clinical trial NCT03224845: Courageous Parents, Courageous Children
Official title: Transgenerational Prevention of Anxiety in Children at Ultra-high Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorder
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
timeFrame: One year post randomization
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
timeFrame: Two years post randomization
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
timeFrame: Three years post randomization
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
timeFrame: Five years post randomization
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
timeFrame: Seven years post randomization
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
timeFrame: Ten years post randomization
Secondary outcomes:
measure: Teaching Task Battery
timeFrame: One year post randomization
measure: Teaching Task Battery
timeFrame: Two years post randomization
measure: Structured Clinical Interview for DSM-5 diagnoses (SCID-5)
timeFrame: One year post randomization
measure: Structured Clinical Interview for DSM-5 diagnoses (SCID-5)
timeFrame: Two years post randomization
measure: Laboratory Temperament Assessment Battery
timeFrame: One year post randomization
measure: Laboratory Temperament Assessment Battery
timeFrame: Two years post randomization
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
timeFrame: Three years post randomization
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
timeFrame: Five years post randomization
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
timeFrame: Seven years post randomization
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
timeFrame: Ten years post randomization
measure: Global Assessment of Functioning
timeFrame: One year post randomization
measure: Global Assessment of Functioning
timeFrame: Two years post randomization
measure: Global Assessment of Functioning
timeFrame: Three years post randomization
measure: Global Assessment of Functioning
timeFrame: Five years post randomization
measure: Global Assessment of Functioning
timeFrame: Seven years post randomization
measure: Global Assessment of Functioning
timeFrame: Ten years post randomization
measure: Screen for Child Anxiety Related Disorders
timeFrame: One year post randomization
measure: Screen for Child Anxiety Related Disorders
timeFrame: Two years post randomization
measure: Screen for Child Anxiety Related Disorders
timeFrame: Three years post randomization
measure: Screen for Child Anxiety Related Disorders
timeFrame: Five years post randomization
measure: Screen for Child Anxiety Related Disorders
timeFrame: Seven years post randomization
measure: Screen for Child Anxiety Related Disorders
timeFrame: Ten years post randomization
measure: Spence Children's Anxiety Scale
timeFrame: One year post randomization
measure: Spence Children's Anxiety Scale
timeFrame: Two years randomization
measure: Spence Children's Anxiety Scale
timeFrame: Three years post randomization
measure: Spence Children's Anxiety Scale
timeFrame: Five years post randomization
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health
state: Nova Scotia
Study officials:
References: