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Neurodevelopmental DisordersNCT03835689

Strongest FamiliesTM Neurodevelopmental

A study testing Strongest Families Intervention (formerly Family Help) in people with Neurodevelopmental Disorders and Behavior Disorders, run by IWK Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 14 yearsHealthy volunteers can take part
What is being tested?
Strongest Families Intervention (formerly Family Help)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
454 participants
Where
1 siteCanada
Study dates
8 Apr 2019to 29 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • IWK Health Centre

    Halifax, Nova Scotia, B3K6R8

Other trials in Canada

About this study

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

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).

Being tested
Strongest Families Intervention (formerly Family Help)
Keywords
Behavioural intervention, E-health intervention, Parenting intervention
Medical subject headings
Neurodevelopmental Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strongest Families Intervention (formerly Family Help)Behavioural

    Also called Formerly the Family Help Program

    Distance HEALTH education intervention focused on skill learning for parents

Study groups in NCT03835689
Study groupRoleWhat they receive
Strongest Families Program Self-Managed (no coaching)ExperimentalThey will receive Strongest Families intervention immediately as well as the usual care services available for the 10 month study period.
Receives: Behavioral: Strongest Families Intervention (formerly Family Help)
Strongest Families Program with Group Telephone CoachingExperimentalThey will receive Strongest Families intervention immediately as well as the usual care services available for the 10 month study period.
Receives: Behavioral: Strongest Families Intervention (formerly Family Help)
Information Resource WebsiteNo interventionThey 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 5 month post-randomization

  2. 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).

    Measured: Baseline and 5 month post-randomization

Secondary outcomes (5)

  1. 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.

    Measured: Baseline and 10 month post-randomization

  2. 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).

    Measured: Baseline and 10 month post-randomization

  3. 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.

    Measured: Baseline, 5 and 10 month post-randomization

  4. 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.

    Measured: Baseline, 5 and 10 month post-randomization

  5. 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.

    Measured: Baseline, 5 and 10 month post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2019
  2. Study start8 Apr 2019
  3. Primary completion29 Aug 2022
  4. Study completion29 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
454 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03835689
Sponsor's protocol ID
REB#1023970
Status last verified
Mar 2022
First submitted
4 Feb 2019
Last updated
4 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Strongest Families Intervention (formerly Family Help) in people with Neurodevelopmental Disorders and Behavior Disorders, run by IWK Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline parenting self-efficacy at 5 month post-randomization (time frame: Baseline and 5 month post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03835689.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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