Clinical trial NCT03835689: Strongest FamiliesTM Neurodevelopmental
Official title: Parent Training for Challenging Behaviour in Children with Neurodevelopmental Disabilities: Strongest FamiliesTM Neurodevelopmental
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurodevelopmental Disorders
Behavior Disorders
Keywords: Behavioural intervention
E-health intervention
Parenting intervention
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: McGill University
name: University of Alberta
name: Child-Bright Network
First posted: 2019-02-08
Enrollment: 454
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Change from baseline parenting self-efficacy at 5 month post-randomization
timeFrame: Baseline and 5 month post-randomization
measure: Change from baseline child's emotion regulation at 5 month post-randomization
timeFrame: Baseline and 5 month post-randomization
Secondary outcomes:
measure: Change from baseline parenting self-efficacy at 10 month post-randomization
timeFrame: Baseline and 10 month post-randomization
measure: Change from baseline child's emotion regulation at 10 month post-randomization
timeFrame: Baseline and 10 month post-randomization
measure: Reduced children's externalizing behaviours
timeFrame: Baseline, 5 and 10 month post-randomization
measure: Improved parental well-being
timeFrame: Baseline, 5 and 10 month post-randomization
measure: Incremental Cost-Effectiveness Ratio (ICER) - Child
timeFrame: Baseline, 5 and 10 month post-randomization
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Patrick J McGrath, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Lucyna Lach, PhD
role: PRINCIPAL_INVESTIGATOR
References: