Back to resultsStrongest FamiliesTM Neurodevelopmental
Primary Purpose
Neurodevelopmental Disorders, Behavior Disorders
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Strongest Families Intervention (formerly Family Help)
Sponsored by
About this trial
This is an interventional treatment trial for Neurodevelopmental Disorders focused on measuring Behavioural intervention, E-health intervention, Parenting intervention
Eligibility Criteria
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
Sites / Locations
- IWK Health Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Strongest Families Program Self-Managed (no coaching)
Strongest Families Program with Group Telephone Coaching
Information Resource Website
Arm Description
They will receive Strongest Families intervention immediately as well as the usual care services available for the 10 month study period.
They will receive Strongest Families intervention immediately as well as the usual care services available for the 10 month study period.
They will not receive Strongest Families Intervention during the 10 month study phase, but will receive the usual care services and access to an Information Resource Website.
Outcomes
Primary Outcome Measures
Change from baseline parenting self-efficacy at 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.
Change from baseline child's emotion regulation at 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).
Secondary Outcome Measures
Change from baseline parenting self-efficacy at 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
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
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
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.
Incremental Cost-Effectiveness Ratio (ICER) - Child
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.
Full Information
NCT ID
NCT03835689
First Posted
February 4, 2019
Last Updated
March 29, 2022
Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR), McGill University, University of Alberta, Child-Bright Network
1. Study Identification
Unique Protocol Identification Number
NCT03835689
Brief Title
Strongest FamiliesTM Neurodevelopmental
Official Title
Parent Training for Challenging Behaviour in Children With Neurodevelopmental Disabilities: Strongest FamiliesTM Neurodevelopmental
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR), McGill University, University of Alberta, Child-Bright Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodevelopmental Disorders, Behavior Disorders
Keywords
Behavioural intervention, E-health intervention, Parenting intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Statistician conducting analysis will be blinded to group assignment
Allocation
Randomized
Enrollment
454 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Strongest Families Program Self-Managed (no coaching)
Arm Type
Experimental
Arm Description
They will receive Strongest Families intervention immediately as well as the usual care services available for the 10 month study period.
Arm Title
Strongest Families Program with Group Telephone Coaching
Arm Type
Experimental
Arm Description
They will receive Strongest Families intervention immediately as well as the usual care services available for the 10 month study period.
Arm Title
Information Resource Website
Arm Type
No Intervention
Arm Description
They will not receive Strongest Families Intervention during the 10 month study phase, but will receive the usual care services and access to an Information Resource Website.
Intervention Type
Behavioral
Intervention Name(s)
Strongest Families Intervention (formerly Family Help)
Other Intervention Name(s)
Formerly the Family Help Program
Intervention Description
Distance HEALTH education intervention focused on skill learning for parents
Primary Outcome Measure Information:
Title
Change from baseline parenting self-efficacy at 5 month post-randomization
Description
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.
Time Frame
Baseline and 5 month post-randomization
Title
Change from baseline child's emotion regulation at 5 month post-randomization
Description
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).
Time Frame
Baseline and 5 month post-randomization
Secondary Outcome Measure Information:
Title
Change from baseline parenting self-efficacy at 10 month post-randomization
Description
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.
Time Frame
Baseline and 10 month post-randomization
Title
Change from baseline child's emotion regulation at 10 month post-randomization
Description
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).
Time Frame
Baseline and 10 month post-randomization
Title
Reduced children's externalizing behaviours
Description
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.
Time Frame
Baseline, 5 and 10 month post-randomization
Title
Improved parental well-being
Description
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.
Time Frame
Baseline, 5 and 10 month post-randomization
Title
Incremental Cost-Effectiveness Ratio (ICER) - Child
Description
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.
Time Frame
Baseline, 5 and 10 month post-randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J McGrath, PhD
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lucyna Lach, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K6R8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Participants will be asked to indicate during Informed Consent whether their de-identified data may be shared with other researchers, provided the study is approved by an ethics board and researchers agree to use the data only for the purposes described in the approved research study. De-identified data from all outcome measures will be made available to approved researchers upon request, provided individual participants have provided consent.
Learn more about this trial
Strongest FamiliesTM Neurodevelopmental
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