Courageous Parents, Courageous Children

NCT03224845 | Recruiting

• 1 other identifier: 1022588
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

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

  Diagnosis of anxiety disorder in the offspring

  One year post randomization

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

  Diagnosis of anxiety disorder in the offspring

  Two years post randomization

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

  Diagnosis of anxiety disorder in the offspring

  Three years post randomization

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

  Diagnosis of anxiety disorder in the offspring

  Five years post randomization

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

  Diagnosis of anxiety disorder in the offspring

  Seven years post randomization

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

  Diagnosis of anxiety disorder in the offspring

  Ten years post randomization

Secondary Outcomes (26)

• Teaching Task Battery

  One year post randomization

• Teaching Task Battery

  Two years post randomization

• Structured Clinical Interview for DSM-5 diagnoses (SCID-5)

  One year post randomization

• Structured Clinical Interview for DSM-5 diagnoses (SCID-5)

  Two years post randomization

• Laboratory Temperament Assessment Battery

  One year post randomization

Study Arms (2)

Cognitive behavioural skills training

EXPERIMENTAL

Behavioral: 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 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.

Cognitive behavioural skills training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Offspring:
• 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.
• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health

Halifax, Nova Scotia, B4E 0H4, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Barbara Pavlova, PhD DClinPsy RPsych

CONTACT

902 473 2585; barbara.pavlova@dal.ca

Jill Cumby, RN

CONTACT

902 473 1781; jill.cumby@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 21, 2017
• Study Start: September 17, 2017
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)