Clinical trial NCT04257331: Parent Training to Reduce Behavioral Problems in Children With Autism Spectrum Disorder in China
Official title: Evaluation of a Parent Training Programme for Families of Children With Autism Spectrum Disorder in China: A Mixed-Methods Quasi-Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior Problem
Autism Spectrum Disorder
Parent-Child Relations
Parenting
Mental Health Issue
Child Abuse
Family Relations
Keywords: Parenting Education
Quasi Experimental Design
Propensity Score Weight
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Beijing Normal University
name: Beijing Stars and Rain Education Institute for Autism
First posted: 2020-02-06
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic quasi-experimental study will be conducted to examine the effectiveness of the SREIA programme. The study will be conducted within the context of routine services and will involve two consecutive deliveries of the SREIA programme. One hundred families of children with ASD age three to six will be recruited and allocated to the two waves of delivery based on their availability and preference, with 50 families in each wave. Each wave will comprise two versions of the programme that are delivered concurrently, with 30 families in version A and 20 in version B. Participants will be self-selected into either version. The 50 families who choose to participate in the first wave will be the treatment group, and the 50 families in the second wave will service as the waitlist control group.
Primary purpose: PREVENTION

Brief summary: Objectives The primary objective of this study is to evaluate the effectiveness of the SREIA parent training program for families of children with ASD aged three to six years in mainland China. The study will be conducted within the context of routine service provision and assess the effectiveness of SREIA in reducing child behavioral problems as measured by the Externalizing scale of the Child Behavior Checklist (CBCL) for Ages 1.5-5, in comparison to a waitlist control group.

Secondary objectives include examining the effectiveness of the SREIA program in reducing ASD symptoms and improving parental and familial outcomes including parental knowledge of ASD and ABA techniques, parenting styles, parental mental health (including stress, anxiety and depression), and family functioning.

A process evaluation will be conducted alongside the quasi-experimental trial, the objectives of which are to 1) describe the implementation aspects of the programs with regard to participant involvement, program acceptability, delivery, and sustainability; 2) explore predictors of participant involvement; and 3) examine potential relations between implementation aspects and treatment effects.

Background ASD is associated with elevated levels of child emotional and behavior disturbance, which impair child daily functioning and impose challenges to parenting. The SREIA programme is a group-based parent training in China, that has been delivered since 1993 and reached over 10,000 families. However, there is an absence of scientific evaluations of programme effectiveness. This study aims to fill this evidence gap, and the findings will be used to inform future modification, replication, and dissemination of the programme in other parts of China. This study will also contribute to the literature on the effectiveness of parent training programmes for ASD and for families living in low- and middle-income countries.

Methods A quasi-experimental design with a mixed-methods approach will be used, involving two consecutive waves of delivery of the SREIA programme. Parent participants will complete demographic and outcome questionnaires at baseline, immediate post-intervention, and 1- or 1.5-year post-intervention (conditional to funding). The implementation components will be assessed by collecting attendance and engagement registry data, facilitators filling out fidelity checklists, research staff observing programme sessions, and parents answering a satisfaction questionnaire. After the programme, some parents, facilitators, and NGO (non-governmental organisation) managers will be invited to take part in qualitative interviews or focus group discussions so as to explore their views about the programme, and to better understand the quantitative data obtained.


Eligibility criteria: The recruitment criteria for parents/primary caregivers from families with children with ASD will follow the existing strategies used by of the implementation organisation. Each primary caregiver will have one child participating in the program. Participating primary caregivers will be those who:

* Aged 18 or older,
* Undertake the responsibility for the daily care of a child between the ages of 3 and 6 years for at least 5 days a week,
* target child meets the diagnostic criteria for Autism Spectrum Disorder according to DSM-V (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition); otherwise, an official letter of ASD diagnosis should be provided, and
* Provide informed consent to participate in the research.

Facilitator Inclusion Criteria:

* Aged 18 or older,
* Employees of the implementation organisation,
* Participate in the delivery of the program during this study, and
* Provide informed consent to participate in the research.

Program Manager Inclusion Criteria:

* Aged 18 or older,
* managers of the program, and
* Provide informed consent to participate in the research.

Parent/Primary Caregiver Exclusion Criteria:

* Parents/primary caregivers will be excluded if the child has been diagnosed with Cerebral Palsy. There will be no additional exclusion criteria.

Primary outcomes:
measure: Change in frequency of child ehavioral problems
timeFrame: Differences between groups within 1 month after the end of intervention
Secondary outcomes:
measure: Change in frequency of ASD symptoms
timeFrame: Differences between groups within 1 month after the end of intervention
measure: Change in frequency of parenting style: over-reactivity
timeFrame: Differences between groups within 1 month after the end of intervention
measure: Change in frequency of parenting style: supportive behaviors
timeFrame: Differences between groups within 1 month after the end of intervention
measure: Change in frequency of parental mental health symptoms
timeFrame: Differences between groups within 1 month after the end of intervention
measure: Change in family function
timeFrame: Differences between groups within 1 month after the end of intervention
measure: Change in parental knowledge
timeFrame: Differences between groups within 1 month after the end of intervention
Other outcomes:
measure: Parent satisfaction: questionnaire
timeFrame: Within 1 month after the end of intervention
measure: Participant involvement
timeFrame: During the intervention
measure: Implementation fidelity
timeFrame: During the intervention
measure: Quality of delivery: survey
timeFrame: During the intervention
measure: Acceptability/involvement/implementation (parents/primary caregivers): semi-structured interview
timeFrame: Six months after the completion of intervention
measure: Acceptability/implementation (facilitators): semi-structured interview
timeFrame: Within 1 month after the end of intervention
measure: Acceptability/implementation/sustainability
timeFrame: Within 1 month after the end of intervention
Locations:
city: Beijing
country: China
facility: Beijing Stars and Rain Education Institute for Autism
state: Beijing
Study officials:
References: