Status:
COMPLETED
Strongest FamiliesTM Neurodevelopmental
Lead Sponsor:
IWK Health Centre
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
McGill University
Conditions:
Neurodevelopmental Disorders
Behavior Disorders
Eligibility:
All Genders
3-14 years
Phase:
NA
Brief Summary
Children and adolescents with neurodevelopmental conditions are 3 to 5 times more likely than their peers to have other mental disorders such as anxiety, depression and disruptive behaviour. Furthermo...
Eligibility Criteria
Inclusion
- SCREENING: Parents/caregivers must meet all of the following criteria to be eligible to proceed to Consent:
- Have a child between 3-14 years of age with a diagnosis of a neurodevelopmental disorder (i.e. Autism Spectrum Disorder, Cerebral Palsy, Epilepsy, Global Developmental Delay, Down Syndrome, Fetal Alcohol Spectrum Disorder (FASD), severe learning disability or any other diagnosis that influences how their child gets around, communicates their ideas, processes what they hear, or remembers things as reported by parents/caregivers).
- The child has been experiencing behavioural problems that interfere with the activities of daily living (as defined by the caregiver) for at least 6 months prior to study screening.
- Have been the primary caregiver for a minimum of 6 months prior to entry into the study.
- Have a reasonable expectation of being be the primary caregiver for at least 10 months after study enrolment.
- Read, write, and understand English.
- Have access to a telephone.
- Have regular access to a tablet, smartphone or computer connected to high speed Internet.
- Live in Canada.
- Commit to the requirements of taking part in the study (e.g. available to attend weekly coaching calls, having a Facebook account to access Parent-to-Parent support group)
- Any of the following criteria will exclude individuals from proceeding to Consent:
- Child is NOT able to understand everyday language and instructions or communicate needs as reported by parent/caregiver.
- Parent or child has ongoing struggles with symptoms of psychosis, schizophrenia, bipolar disorder or major depression (i.e. the symptoms are not well managed).
- Child is at imminent risk of serious harm to self or others (i.e. requiring hospitalization or medical attention).
- Child regularly engages in moderate to severe self-injurious behaviours, as reported by the parent.
- Child has attempted suicide in the past 6 months.
- Parent has previously taken part in a Strongest Families Parenting Program.
- Parent has taken part in Triple P, COPE, Incredible Years or another parent training program within 6 months prior to starting the study.
- BASELINE ASSESSMENT:
- Meet minimum score of 16 (for ages 2 - 4 years) or 17 (for ages 4-17) on the Total Difficulties Score of the Strengths and Difficulties Questionnaire.
- Meet a minimum level of child's cognitive functioning as determined by the question\* below. Parents must endorse 1, 2 or 3 on the following question:
- Compared with children of the same age, does your child have difficulty learning things? Would you say your child has: no difficulty, some difficulty, a lot of difficulty or cannot do at all? No difficulty........................ 1 Some difficulty....................2 A lot of difficulty..................3 Cannot do at .....................4
Exclusion
Key Trial Info
Start Date :
April 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2022
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT03835689
Start Date
April 8 2019
End Date
August 29 2022
Last Update
October 4 2024
Active Locations (1)
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1
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K6R8