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NCT Number: NCT03224845

Courageous Parents, Courageous Children

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Scotia Health

Halifax, Nova Scotia, B4E 0H4, Canada

Location status: Recruiting

Location contact

Jill Cumby

CONTACT

[email protected]

902-473-1781

Who can participate

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.

Treatment and study plan

Cognitive behavioural skills training

Behavioral

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 outcomes

  1. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)

    Time frame: One year post randomization

    Diagnosis of anxiety disorder in the offspring

  2. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)

    Time frame: Two years post randomization

    Diagnosis of anxiety disorder in the offspring

  3. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)

    Time frame: Three years post randomization

    Diagnosis of anxiety disorder in the offspring

  4. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)

    Time frame: Five years post randomization

    Diagnosis of anxiety disorder in the offspring

  5. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)

    Time frame: Seven years post randomization

    Diagnosis of anxiety disorder in the offspring

  6. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)

    Time frame: Ten years post randomization

    Diagnosis of anxiety disorder in the offspring

Secondary outcomes

  1. Teaching Task Battery

    Time frame: One year post randomization

    Parenting behaviours

  2. Teaching Task Battery

    Time frame: Two years post randomization

    Parenting behaviours

  3. Structured Clinical Interview for DSM-5 diagnoses (SCID-5)

    Time frame: One year post randomization

    Diagnosis of anxiety disorder in the parent

  4. Structured Clinical Interview for DSM-5 diagnoses (SCID-5)

    Time frame: Two years post randomization

    Diagnosis of anxiety disorder in the parent

  5. Laboratory Temperament Assessment Battery

    Time frame: One year post randomization

    Temperament in the offspring

  6. Laboratory Temperament Assessment Battery

    Time frame: Two years post randomization

    Temperament in the offspring

  7. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)

    Time frame: Three years post randomization

    Diagnosis of major mood and psychotic disorders in offspring

  8. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)

    Time frame: Five years post randomization

    Diagnosis of major mood and psychotic disorders in offspring

  9. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)

    Time frame: Seven years post randomization

    Diagnosis of major mood and psychotic disorders in offspring

  10. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)

    Time frame: Ten years post randomization

    Diagnosis of major mood and psychotic disorders in offspring

  11. Global Assessment of Functioning

    Time frame: One year post randomization

    Functioning in the offspring

  12. Global Assessment of Functioning

    Time frame: Two years post randomization

    Functioning in the offspring

  13. Global Assessment of Functioning

    Time frame: Three years post randomization

    Functioning in the offspring

  14. Global Assessment of Functioning

    Time frame: Five years post randomization

    Functioning in the offspring

  15. Global Assessment of Functioning

    Time frame: Seven years post randomization

    Functioning in the offspring

  16. Global Assessment of Functioning

    Time frame: Ten years post randomization

    Functioning in the offspring

  17. Screen for Child Anxiety Related Disorders

    Time frame: One year post randomization

    Anxiety in the offspring - continuous

  18. Screen for Child Anxiety Related Disorders

    Time frame: Two years post randomization

    Anxiety in the offspring - continuous

  19. Screen for Child Anxiety Related Disorders

    Time frame: Three years post randomization

    Anxiety in the offspring - continuous

  20. Screen for Child Anxiety Related Disorders

    Time frame: Five years post randomization

    Anxiety in the offspring - continuous

  21. Screen for Child Anxiety Related Disorders

    Time frame: Seven years post randomization

    Anxiety in the offspring - continuous

  22. Screen for Child Anxiety Related Disorders

    Time frame: Ten years post randomization

    Anxiety in the offspring - continuous

  23. Spence Children's Anxiety Scale

    Time frame: One year post randomization

    Anxiety in the offspring - continuous

  24. Spence Children's Anxiety Scale

    Time frame: Two years randomization

    Anxiety in the offspring - continuous

  25. Spence Children's Anxiety Scale

    Time frame: Three years post randomization

    Anxiety in the offspring - continuous

  26. Spence Children's Anxiety Scale

    Time frame: Five years post randomization

    Anxiety in the offspring - continuous

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Pavlova, PhD DClinPsy RPsych

CONTACT

[email protected]

902 473 2585

Jill Cumby, RN

CONTACT

[email protected]

902 473 1781

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

Transgenerational Prevention of Anxiety in Children at Ultra-high Risk

Acronym: COACH

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Jul 21, 2017
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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