Courageous Parents, Courageous Children (COACH)

Transgenerational Prevention of Anxiety in Children at Ultra-high Risk

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.

Study Overview

• Status: Unknown
• Conditions: Anxiety Disorder
• Intervention / Treatment: Behavioral: Cognitive behavioural skills training

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cognitive behavioural skills training	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 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.
NO_INTERVENTION: No intervention; Participants in the control group will receive their usual clinical care and will not be discouraged from seeking any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Teaching Task Battery	Parenting behaviours	One year post randomization
Teaching Task Battery	Parenting behaviours	Two years post randomization
Structured Clinical Interview for DSM-5 diagnoses (SCID-5)	Diagnosis of anxiety disorder in the parent	One year post randomization
Structured Clinical Interview for DSM-5 diagnoses (SCID-5)	Diagnosis of anxiety disorder in the parent	Two years post randomization
Laboratory Temperament Assessment Battery	Temperament in the offspring	One year post randomization
Laboratory Temperament Assessment Battery	Temperament in the offspring	Two years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)	Diagnosis of major mood and psychotic disorders in offspring	Three years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)	Diagnosis of major mood and psychotic disorders in offspring	Five years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)	Diagnosis of major mood and psychotic disorders in offspring	Seven years post randomization
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)	Diagnosis of major mood and psychotic disorders in offspring	Ten years post randomization
Global Assessment of Functioning	Functioning in the offspring	One year post randomization
Global Assessment of Functioning	Functioning in the offspring	Two years post randomization
Global Assessment of Functioning	Functioning in the offspring	Three years post randomization
Global Assessment of Functioning	Functioning in the offspring	Five years post randomization
Global Assessment of Functioning	Functioning in the offspring	Seven years post randomization
Global Assessment of Functioning	Functioning in the offspring	Ten years post randomization
Screen for Child Anxiety Related Disorders	Anxiety in the offspring - continuous	One year post randomization
Screen for Child Anxiety Related Disorders	Anxiety in the offspring - continuous	Two years post randomization
Screen for Child Anxiety Related Disorders	Anxiety in the offspring - continuous	Three years post randomization
Screen for Child Anxiety Related Disorders	Anxiety in the offspring - continuous	Five years post randomization
Screen for Child Anxiety Related Disorders	Anxiety in the offspring - continuous	Seven years post randomization
Screen for Child Anxiety Related Disorders	Anxiety in the offspring - continuous	Ten years post randomization
Spence Children's Anxiety Scale	Anxiety in the offspring - continuous	One year post randomization
Spence Children's Anxiety Scale	Anxiety in the offspring - continuous	Two years randomization
Spence Children's Anxiety Scale	Anxiety in the offspring - continuous	Three years post randomization
Spence Children's Anxiety Scale	Anxiety in the offspring - continuous	Five years post randomization

Collaborators and Investigators

• Sponsor: Barbara Pavlova

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2017
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (ACTUAL): July 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 1022588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No