An interventional study of Cognitive behavioural skills training in Anxiety Disorder, sponsored by Nova Scotia Health Authority. Status unknown at 1 site in Canada. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Prevention
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.
5,065 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's planned enrollment of 88 is close to the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Nova Scotia Health Authority is the lead sponsor of 264 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Behavioral: Cognitive behavioural skills training
Participants in the control group will receive their usual clinical care and will not be discouraged from seeking any intervention.
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.
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Time frame: One year post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Time frame: Two years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Time frame: Three years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Time frame: Five years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Time frame: Seven years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of anxiety disorder in the offspring
Time frame: Ten years post randomization
Teaching Task Battery
Parenting behaviours
Time frame: One year post randomization
Teaching Task Battery
Parenting behaviours
Time frame: Two years post randomization
Structured Clinical Interview for DSM-5 diagnoses (SCID-5)
Diagnosis of anxiety disorder in the parent
Time frame: One year post randomization
Structured Clinical Interview for DSM-5 diagnoses (SCID-5)
Diagnosis of anxiety disorder in the parent
Time frame: Two years post randomization
Laboratory Temperament Assessment Battery
Temperament in the offspring
Time frame: One year post randomization
Laboratory Temperament Assessment Battery
Temperament in the offspring
Time frame: Two years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of major mood and psychotic disorders in offspring
Time frame: Three years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of major mood and psychotic disorders in offspring
Time frame: Five years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of major mood and psychotic disorders in offspring
Time frame: Seven years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Diagnosis of major mood and psychotic disorders in offspring
Time frame: Ten years post randomization
Global Assessment of Functioning
Functioning in the offspring
Time frame: One year post randomization
Global Assessment of Functioning
Functioning in the offspring
Time frame: Two years post randomization
Global Assessment of Functioning
Functioning in the offspring
Time frame: Three years post randomization
Global Assessment of Functioning
Functioning in the offspring
Time frame: Five years post randomization
Global Assessment of Functioning
Functioning in the offspring
Time frame: Seven years post randomization
Global Assessment of Functioning
Functioning in the offspring
Time frame: Ten years post randomization
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Time frame: One year post randomization
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Time frame: Two years post randomization
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Time frame: Three years post randomization
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Time frame: Five years post randomization
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Time frame: Seven years post randomization
Screen for Child Anxiety Related Disorders
Anxiety in the offspring - continuous
Time frame: Ten years post randomization
Spence Children's Anxiety Scale
Anxiety in the offspring - continuous
Time frame: One year post randomization
Spence Children's Anxiety Scale
Anxiety in the offspring - continuous
Time frame: Two years randomization
Spence Children's Anxiety Scale
Anxiety in the offspring - continuous
Time frame: Three years post randomization
Spence Children's Anxiety Scale
Anxiety in the offspring - continuous
Time frame: Five years post randomization
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2017 (actual). Primary completion is estimated for Sep 2025, 96 months after the start.
Of 2,720 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 96 months is above that.
Counting every sponsor, half of 2,789 studies reached it within 12 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Nova Scotia Health Authority →