Recruiting

Anxiety Prevention Program

Sponsor:

Nova Scotia Health Authority

Code:

NCT03224845

Conditions

Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Cognitive behavioural skills training

Study Details

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.

Conditions

Anxiety Disorder

Study ID

NCT03224845

Start date

Sep 17, 2017

Status verified date

Aug, 2024

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cognitive behavioural skills training

no intervention: No intervention

Participants in the control group will receive their usual clinical care and will not be discouraged from seeking any intervention.

Interventions

Cognitive behavioural skills training

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.

Primary outcome measure

  • Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) [ Time Frame: One year post randomization ]
  • Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) [ Time Frame: Two years post randomization ]
  • Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) [ Time Frame: Three years post randomization ]
  • Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) [ Time Frame: Five years post randomization ]
  • Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) [ Time Frame: Seven years post randomization ]
  • Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) [ Time Frame: Ten years post randomization ]

Central Contacts and Locations

Central contacts

Barbara Pavlova, PhD DClinPsy RPsych

902 473 2585barbara.pavlova@dal.ca

Jill Cumby, RN

902 473 1781jill.cumby@nshealth.ca

Locations

Nova Scotia Health

Recruiting

Halifax, Nova Scotia, Canada, B4E 0H4

Contacts

Jill Cumby

902-473-1781jill.cumby@nshealth.ca

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Aug 21, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2024-08-21.