Courageous Parents, Courageous Children

Official title

Transgenerational Prevention of Anxiety in Children at Ultra-high Risk

Overview

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.

Interventions

• Behavioral 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 trans

Primary outcome measures

• 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]

Secondary outcome measures (12)

• Teaching Task Battery [Time frame: One year post randomization]
• Teaching Task Battery [Time frame: Two years post randomization]
• Structured Clinical Interview for DSM-5 diagnoses (SCID-5) [Time frame: One year post randomization]
• Structured Clinical Interview for DSM-5 diagnoses (SCID-5) [Time frame: Two years post randomization]
• Laboratory Temperament Assessment Battery [Time frame: One year post randomization]
• Laboratory Temperament Assessment Battery [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]
• Global Assessment of Functioning [Time frame: One year post randomization]
• Global Assessment of Functioning [Time frame: Two years post randomization]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Canada · 1 center

• Nova Scotia Health — Halifax

Identifiers

NCT: NCT03224845 · 1022588

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗