Strongest FamiliesTM Neurodevelopmental

NCT ID: NCT03835689

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 454 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-08
• Study Completion Date: 2022-08-29

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).

Conditions

Neurodevelopmental Disorders; Behavior Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Strongest Families Intervention (formerly Family Help)

Intervention Type: BEHAVIORAL

Distance HEALTH education intervention focused on skill learning for parents

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.

Group Type: EXPERIMENTAL

Strongest Families Intervention (formerly Family Help)

Intervention Type: BEHAVIORAL

Distance HEALTH education intervention focused on skill learning for parents

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Strongest Families Intervention (formerly Family Help)

Distance HEALTH education intervention focused on skill learning for parents

Intervention Type: BEHAVIORAL

Other Intervention Names

Formerly the Family Help Program

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

Child-Bright Network

OTHER

Sponsor Role: collaborator

IWK Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Patrick J. McGrath

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick J McGrath, PhD

Role: PRINCIPAL_INVESTIGATOR

IWK Health Centre

Lucyna Lach, PhD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

IWK Health Centre

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

REB#1023970

Identifier Type: -

Identifier Source: org_study_id