Parents of Newly Diagnosed Preschool Children With Autism Spectrum Disorder:

NCT03005431 | Unknown DMC

• 1 other identifier: HS20295 (H2016:427)
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Manitoba parents of preschool children newly diagnosed with Autism must wait up to a year to receive government funded services for their child. During this delay parents need support and training to promote their child's development. The purpose of this research is to develop and evaluate an on-line, parent training and support program that will assist parents during this time. It is predicted that if parents receive on-line training and support they will increase their parenting knowledge and skills, reduce their stress, and create better outcomes for their child, in comparison to parents who do not receive the training. The experimental study (n=60) will use a randomized, masked, waitlist control design that compares a treatment group to a control group. Descriptive statistics will be used to describe differences between groups, ANCOVA's to test for differences between groups, and Pearson correlations to describe the relationship between parent stress and outcomes.

Conditions

Autism

Keywords

Parenting; Training; Support; On-line; Stress

Outcome Measures

Primary Outcomes (4)

• Change in the Parent's Knowledge of ASD and Early Home Intervention Questionnaire.

  This questionnaire was developed specifically for this study to assess the parent's perceptions of their knowledge of ASD and early home intervention techniques. This questionnaire was developed because no pre-existing measure could be found that addressed caregiver perceptions of their knowledge of ASD and early intervention techniques. Parents in the study will respond to 30 questions related to the diagnosis of ASD (e.g. I understand how ASD is diagnosed.); characteristics of children with ASD (e.g. I understand why my child may have unusual sensory interests); parental support (e.g. I know the services available in the community to support my child and family); and parent early intervention techniques (e.g. I know ways to promote communication in my child) using a 5 point scale from 1 (no understanding) to 5 (an excellent understanding) to produce an overall score (range 30 to 150).

  Baseline and then in four months

• Change in the Early Intervention Techniques Parent Rating Scale.

  This rating scale assesses the parent's use of early intervention techniques during the pre and post 10 minute video recorded parent/child play session. The rating scale was developed specifically for this study to assess the parent's use of the early intervention techniques specific to the training involved in this study. The examiner will watch the ten minute video and then rate the parents on their frequency of usage of seven early intervention techniques; 1) Follows the Child's Lead/Engages Child, 2) Imitation, 3) Expanding/Modelling, 4) Reciprocity/Turn Taking, 5) Promotes Communication, 6) Promotes Regulation, and 7) Promotes Appropriate Behaviour. Each individual item is rated using 1-5 Likert scale for frequency, 1) Never, 2) Rarely, 3) Sometimes, 4) Often, 5) Always, to produce an overall score (Range 7-35).

  Baseline and then in four months

• Change in Parent/Child Joint Engagement

  An observational measure will be used to evaluate the child's level of joint engagement with the parent during the pre and post 10 minute video recorded parent/child play session. An evaluation of joint engagement was chosen as it is an important metric of parent child interactions, an important developmental precursor to communication, and a measurement that has been shown to be sensitive to treatment related changes for toddlers and early preschool children (Kasari et al., 2010; Schertz, Odem, Baggett, \& Sideris, 2013). The 10 minute parent/child video recorded play session from both pre and post intervention will be observed continuously and coded in 5 second intervals for three levels of child engagement: Unengaged, Object Engagement, and Joint Engagement. A data collection sheet for the time sampling procedure will be used to record a 120 - 5 second intervals, which will total 10 minutes.

  Baseline and then in four months

• Change in Expressive Communication Measure

  An observational measure will be used to evaluate the child's expressive communication during the pre and post 10 minute video recorded parent/child play session. An expressive communication measure was chosen because it is a core deficit of ASD and a common outcome measure used to evaluate parent training interventions for toddlers and preschoolers with ASD (Beaudoin, Sebire, \& Couture, 2014). The 10 minute parent/child video recorded play session from both pre and post intervention will be observed continuously and coded in 5 second intervals for five levels of child expressive communications: Gestures, Vocalizations, Word approximations, Words, and Multi-word utterances. Operational definitions from Harjuson-Webb and Robbins, (2012), are used. A data collection sheet will be used to record a frequency count in each category over the 10 minute video recorded caregiver/child play session.

  Baseline and then in four months

Secondary Outcomes (2)

• Change in the Parenting Stress Index-Short Form

  Baseline and then in four months

• Change in the Family Support Scale

  Baseline and then in four months

Study Arms (2)

Parent training and support

EXPERIMENTAL

Parents will be given access to participate in an on-line support forum and a set of on-line parent training modules.

Behavioral: Parent training and support

Waitlist control group

NO INTERVENTION

These parents will receive regular or typical services

Interventions

Parent training and support BEHAVIORAL

Parents will be given access to participate in an on-line support forum and a set of on-line parent training modules.

Parent training and support

Eligibility Criteria

• Age: Up to 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children will be eligible for the study if they are less than 60 months of age and have a formal documented diagnosis of ASD.

You may not qualify if:

• Children who have another formally diagnosed co-morbidity (e.g. Cerebral Palsy, FASD, ADHD), or who have parents not able to read English will be excluded from the study.

Sponsors & Collaborators

• University of Manitoba: lead

MeSH Terms

Conditions

Autistic Disorder

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Andrew T Robson, M.Sc.

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 29, 2016
• Study Start: January 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: October 3, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share