Strongest FamiliesTM Neurodevelopmental
- Conditions
- Neurodevelopmental DisordersBehavior Disorders
- Interventions
- Behavioral: Strongest Families Intervention (formerly Family Help)
- Registration Number
- NCT03835689
- Lead Sponsor
- IWK Health Centre
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 454
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Strongest Families Program with Group Telephone Coaching Strongest Families Intervention (formerly Family Help) They will receive Strongest Families intervention immediately as well as the usual care services available for the 10 month study period. Strongest Families Program Self-Managed (no coaching) Strongest Families Intervention (formerly Family Help) They will receive Strongest Families intervention immediately as well as the usual care services available for the 10 month study period.
- Primary Outcome Measures
Name Time Method Change from baseline child's emotion regulation at 5 month post-randomization 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 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 Outcome Measures
Name Time Method Incremental Cost-Effectiveness Ratio (ICER) - Child Baseline, 5 and 10 month post-randomization ICER are calculated by dividing the difference in cost by the difference in effectiveness when comparing two interventions and represent the additional cost or savings associated with gaining or losing an additional unit of effectiveness. To assess the value for money of an intervention relative to another, decision-makers can compare ICER values to the amount their jurisdiction would be willing to pay to gain or willing to accept to forgo a unit of the effectiveness outcome that was included in the ICER. Cost will be measured in Canadian dollars and effectiveness will be measured using quality adjusted life years (QALY). Cost and effectiveness will reflect those of the child.
Change from baseline parenting self-efficacy at 10 month post-randomization Baseline and 10 month post-randomization Statistically significant improvement in parent report of self-efficacy from baseline to 10 month follow up for both intervention groups compared to control, as measured by the total score of 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.
Change from baseline child's emotion regulation at 10 month post-randomization Baseline and 10 month post-randomization Statistically significant improvement in emotion regulation from baseline to 10 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).
Reduced children's externalizing behaviours Baseline, 5 and 10 month post-randomization Statistically significant reduction in child's behavior problems between baseline and 5 months and baseline and 10 months for both interventions groups compared to control, as measured by the Difficulties score of the Strengths and Difficulties Questionnaire (SDQ). The SDQ measures children's emotional problems, conduct disorder, hyperactivity, peer problems and prosocial behavior. The Total Difficulties scores is calculated by summing all scores except items on the prosocial scale. Scores range from 0 - 40 with higher scores indicating more problematic behavior.
Improved parental well-being Baseline, 5 and 10 month post-randomization Statistically significant reduction of parent report of depression, anxiety and stress from baseline to 5 months and baseline to 10 months for both interventions groups compared to control, as measured by total score of the Depression, Anxiety, Stress Scale - 21 (DASS-21). The DASS-21 measures severity of symptoms related to depression, anxiety and stress. Respondents rate how much each symptom applied to them in the past week using a scale from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Total scores are calculated by summing responses and multiplying by 2 to allow comparison to severity scores established with the long form of the DASS which has 42 items (e.g. normal to extremely severe). Scores range from 0 - 126, with higher scores indicating more distress.
Trial Locations
- Locations (1)
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada