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Clinical Trials/NCT03835689
NCT03835689
Completed
N/A

Parent Training for Challenging Behaviour in Children with Neurodevelopmental Disabilities: Strongest FamiliesTM Neurodevelopmental

IWK Health Centre1 site in 1 country454 target enrollmentApril 8, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neurodevelopmental Disorders
Sponsor
IWK Health Centre
Enrollment
454
Locations
1
Primary Endpoint
Change from baseline child's emotion regulation at 5 month post-randomization
Status
Completed
Last Updated
last year

Overview

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. Furthermore, these conditions are less likely to be recognized, diagnosed and treated than for typically developing children. Parent training is a well-established approach to help parents change their behaviour and communication with their children with the goal of improving child behaviours. Parent-focused programs that are designed for typically developing children have shown mixed results for children with neurodevelopmental conditions and parents have reported significant challenges in accessing traditional health services due to barriers to care. There is an urgent need to explore how effective distance-delivered parenting programs can be implemented in real-world settings and how they should be adapted to meet the needs of families with children with neurodevelopmental conditions. The goal of this research project is to develop and test the effectiveness of two versions (group coaching & self-managed) of an online parenting program for managing challenging behaviours in children with neurodevelopmental disabilities. The Strongest Families Neurodevelopmental program is based on the well-established Strongest Families Parenting program for typically developing children with challenging behaviours, adapted with substantial involvement from a pan-Canadian Parent Advisory Committee. The program consists of 11 skill-based sessions with demonstration videos, audio clips, exercises, a resource webpage and a Parent-to-Parent online group (a closed Facebook group).

Registry
clinicaltrials.gov
Start Date
April 8, 2019
End Date
August 29, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Patrick J. McGrath

Principal investigator

IWK Health Centre

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change from baseline child's emotion regulation at 5 month post-randomization

Time Frame: Baseline and 5 month post-randomization

Statistically significant improvement in emotion regulation from baseline to 5 months for both intervention groups compared to control, as measured by the total score of the Emotion Regulation Checklist (ERC). The 24-item scale consists of two subscales: Lability/Negativity characterized by inflexibility, mood swings and dysregulated negative affect (e.g., "is prone to angry outbursts/tantrums easily"), and Emotion Regulation representing appropriate affect, empathy and awareness of one's emotions (e.g., "responds positively to neutral or friendly approaches by peers'). Parents are asked to report, on a 4 point Likert-type scale ranging from Never to Almost Always, how much each statement applies to their child. An overall emotional regulation score is calculated by reverse scoring the Emotion Regulation items and summing all questionnaire items; a higher score indicating more dysregulation. We will use total scores which range from 23 - 92 (item 12 is not used in the calculation).

Change from baseline parenting self-efficacy at 5 month post-randomization

Time Frame: Baseline and 5 month post-randomization

Statistically significant improvement in parent report of self-efficacy from baseline to 5 month follow up for both intervention groups compared to control, as measured by the total score on the Self-Efficacy subscale of the Child Adjustment and Parent Efficacy Scale - Developmental Disability (CAPES-DD) questionnaire. The CAPES-DD assesses emotional and behavioural problems in children with developmental disabilities (age 2 - 16 years) and their parents' self-efficacy to manage specific problematic behaviours. For each of 16 problem child behaviours, respondents are asked to rate their confidence in their ability to successfully manage the behaviour. Ratings range on a scale from 1 ('certain I can't manage it') to 10 ('certain I can manage it'). Total scores range from 16 - 160 with higher scores indicating greater levels of parent self-efficacy.

Secondary Outcomes

  • Incremental Cost-Effectiveness Ratio (ICER) - Child(Baseline, 5 and 10 month post-randomization)
  • Change from baseline parenting self-efficacy at 10 month post-randomization(Baseline and 10 month post-randomization)
  • Change from baseline child's emotion regulation at 10 month post-randomization(Baseline and 10 month post-randomization)
  • Reduced children's externalizing behaviours(Baseline, 5 and 10 month post-randomization)
  • Improved parental well-being(Baseline, 5 and 10 month post-randomization)

Study Sites (1)

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