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Strongest FamiliesTM Neurodevelopmental

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ClinicalTrials.gov Identifier: NCT03835689
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
McGill University
University of Alberta
CHILD-BRIGHT Network
Information provided by (Responsible Party):
Patrick J. McGrath, 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).

Condition or disease Intervention/treatment Phase
Neurodevelopmental Disorders Behavior Disorders Behavioral: Strongest Families Intervention (formerly Family Help) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Statistician conducting analysis will be blinded to group assignment
Primary Purpose: Treatment
Official Title: Parent Training for Challenging Behaviour in Children With Neurodevelopmental Disabilities: Strongest FamiliesTM Neurodevelopmental
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

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.
Behavioral: Strongest Families Intervention (formerly Family Help)
Distance HEALTH education intervention focused on skill learning for parents
Other Name: Formerly the Family Help Program

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.
Behavioral: Strongest Families Intervention (formerly Family Help)
Distance HEALTH education intervention focused on skill learning for parents
Other Name: Formerly the Family Help Program

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.



Primary Outcome Measures :
  1. 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 Self-Efficacy Scale of the Child Adjustment and Parent Efficacy Scale - Developmental Disability (CAPES-DD) questionnaire.

  2. 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).


Secondary Outcome Measures :
  1. 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 Self-Efficacy Scale of the Child Adjustment and Parent Efficacy Scale - Developmental Disability (CAPES-DD) questionnaire.

  2. 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 5 months for both intervention groups compared to control, as measured by the total score of the Emotion Regulation Checklist (ERC).

  3. Reduced children's externalizing behaviours [ Time Frame: Baseline, 5 and 10 month post-randomization ]
    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 Total Problems score of the Strengths and Difficulties Questionnaire (SDQ)

  4. Improved parental well-being [ Time Frame: 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.

  5. Incremental Cost-Effectiveness Ratio (ICER) - Child [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

SCREENING: Parents/caregivers must meet all of the following criteria to be eligible to proceed to Consent:

  1. 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).
  2. 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.
  3. Have been the primary caregiver for a minimum of 6 months prior to entry into the study.
  4. Have a reasonable expectation of being be the primary caregiver for at least 10 months after study enrolment.
  5. Read, write, and understand English.
  6. Have access to a telephone.
  7. Have regular access to a tablet, smartphone or computer connected to high speed Internet.
  8. Live in Canada.
  9. 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:

  1. Child is NOT able to understand everyday language and instructions or communicate needs as reported by parent/caregiver.
  2. Parent or child has ongoing struggles with symptoms of psychosis, schizophrenia, bipolar disorder or major depression (i.e. the symptoms are not well managed).
  3. Child is at imminent risk of serious harm to self or others (i.e. requiring hospitalization or medical attention).
  4. Child regularly engages in moderate to severe self-injurious behaviours, as reported by the parent.
  5. Child has attempted suicide in the past 6 months.
  6. Parent has previously taken part in a Strongest Families Parenting Program.
  7. 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:

  1. 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.
  2. 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835689


Contacts
Contact: Patricia A Lingley-Pottie, BNRN, PhD 902-442-9521 ppottie@strongestfamilies.com
Contact: Adam Cummins 902-470-7401 adam.cummins@iwk.nshealth.ca

Sponsors and Collaborators
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
McGill University
University of Alberta
CHILD-BRIGHT Network
Investigators
Principal Investigator: Patrick J McGrath, PhD IWK Health Centre
Principal Investigator: Lucyna Lach, PhD McGill University

Responsible Party: Patrick J. McGrath, Principal investigator, IWK Health Centre
ClinicalTrials.gov Identifier: NCT03835689     History of Changes
Other Study ID Numbers: REB#1023970
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patrick J. McGrath, IWK Health Centre:
Behavioural intervention
E-health intervention
Parenting intervention

Additional relevant MeSH terms:
Disease
Mental Disorders
Neurodevelopmental Disorders
Pathologic Processes