Nova Scotia Health
Halifax, Nova Scotia, B4E 0H4, Canada
Location status: Recruiting
NCT Number: NCT03224845
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.
Interested in participating?
Request InfoAll sexes
Interventional
Not applicable
Halifax, Nova Scotia, B4E 0H4, Canada
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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.
Time frame: One year post randomization
Diagnosis of anxiety disorder in the offspring
Time frame: Two years post randomization
Diagnosis of anxiety disorder in the offspring
Time frame: Three years post randomization
Diagnosis of anxiety disorder in the offspring
Time frame: Five years post randomization
Diagnosis of anxiety disorder in the offspring
Time frame: Seven years post randomization
Diagnosis of anxiety disorder in the offspring
Time frame: Ten years post randomization
Diagnosis of anxiety disorder in the offspring
Time frame: One year post randomization
Parenting behaviours
Time frame: Two years post randomization
Parenting behaviours
Time frame: One year post randomization
Diagnosis of anxiety disorder in the parent
Time frame: Two years post randomization
Diagnosis of anxiety disorder in the parent
Time frame: One year post randomization
Temperament in the offspring
Time frame: Two years post randomization
Temperament in the offspring
Time frame: Three years post randomization
Diagnosis of major mood and psychotic disorders in offspring
Time frame: Five years post randomization
Diagnosis of major mood and psychotic disorders in offspring
Time frame: Seven years post randomization
Diagnosis of major mood and psychotic disorders in offspring
Time frame: Ten years post randomization
Diagnosis of major mood and psychotic disorders in offspring
Time frame: One year post randomization
Functioning in the offspring
Time frame: Two years post randomization
Functioning in the offspring
Time frame: Three years post randomization
Functioning in the offspring
Time frame: Five years post randomization
Functioning in the offspring
Time frame: Seven years post randomization
Functioning in the offspring
Time frame: Ten years post randomization
Functioning in the offspring
Time frame: One year post randomization
Anxiety in the offspring - continuous
Time frame: Two years post randomization
Anxiety in the offspring - continuous
Time frame: Three years post randomization
Anxiety in the offspring - continuous
Time frame: Five years post randomization
Anxiety in the offspring - continuous
Time frame: Seven years post randomization
Anxiety in the offspring - continuous
Time frame: Ten years post randomization
Anxiety in the offspring - continuous
Time frame: One year post randomization
Anxiety in the offspring - continuous
Time frame: Two years randomization
Anxiety in the offspring - continuous
Time frame: Three years post randomization
Anxiety in the offspring - continuous
Time frame: Five years post randomization
Anxiety in the offspring - continuous
Contact information is provided by the study sponsor or research team.
Barbara Pavlova, PhD DClinPsy RPsych
CONTACT
Jill Cumby, RN
CONTACT
Nova Scotia Health Authority
Other
Transgenerational Prevention of Anxiety in Children at Ultra-high Risk
Acronym: COACH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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