- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03835689
Strongest FamiliesTM Neurodevelopmental
Parent Training for Challenging Behaviour in Children With Neurodevelopmental Disabilities: Strongest FamiliesTM Neurodevelopmental
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K6R8
- IWK Health Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Strongest Families Program Self-Managed (no coaching)
They will receive Strongest Families intervention immediately as well as the usual care services available for the 10 month study period.
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Distance HEALTH education intervention focused on skill learning for parents
Other Names:
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Experimental: Strongest Families Program with Group Telephone Coaching
They will receive Strongest Families intervention immediately as well as the usual care services available for the 10 month study period.
|
Distance HEALTH education intervention focused on skill learning for parents
Other Names:
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No Intervention: Information Resource Website
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline parenting self-efficacy at 5 month post-randomization
Time Frame: Baseline and 5 month post-randomization
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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.
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Baseline and 5 month post-randomization
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Change from baseline child's emotion regulation at 5 month post-randomization
Time Frame: Baseline and 5 month post-randomization
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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).
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Baseline and 5 month post-randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline parenting self-efficacy at 10 month post-randomization
Time Frame: 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.
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Baseline and 10 month post-randomization
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Change from baseline child's emotion regulation at 10 month post-randomization
Time Frame: 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).
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Baseline and 10 month post-randomization
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Reduced children's externalizing behaviours
Time Frame: Baseline, 5 and 10 month post-randomization
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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.
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Baseline, 5 and 10 month post-randomization
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Improved parental well-being
Time Frame: Baseline, 5 and 10 month post-randomization
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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.
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Baseline, 5 and 10 month post-randomization
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Incremental Cost-Effectiveness Ratio (ICER) - Child
Time Frame: Baseline, 5 and 10 month post-randomization
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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.
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Baseline, 5 and 10 month post-randomization
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrick J McGrath, PhD, IWK Health Centre
- Principal Investigator: Lucyna Lach, PhD, McGill University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB#1023970
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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