Parent Training to Reduce Behavioral Problems in Children With Autism Spectrum Disorder in China

NCT ID: NCT04257331

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-10-12

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.

Conditions

Child Behavior Problem; Autism Spectrum Disorder; Parent-Child Relations; Parenting; Mental Health Issue; Child Abuse; Family Relations

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

SREIA group

Participants in this arm will be families who attend the first wave of the two rounds of delivery. They will be the intervention group.

Group Type: EXPERIMENTAL

Stars and Rain Education Institute for Autism (SREIA) Parent Training Programme

Intervention Type: BEHAVIORAL

The SREIA program is grounded in applied behavior analysis and developmental theories. It aims to reduce child behavioral problems and promote child development by improving parental attitudes and parenting styles. The program targets parent-child dyads from families of children with ASD aged between three and six years. It is delivered five days a week for 11 weeks. Fourteen two-hour lectures on weekly themes (such as knowledge of ASD, parent-child interaction, and behavior management techniques) are offered throughout the 11 weeks and attended by all participating parents. For the remaining time, additional training in ABA principles and practice are tailored for the different functioning groups. The program offers a combination of individual counselling and group sessions, as well as a mixture of didactic and interactive delivery modes. All sessions are delivered in person. Some sessions are only for parents and others are participated in by both parent and child.

Waitlist Control

Participants in this arm will be families who attend the second wave of the two rounds of delivery. They will be the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stars and Rain Education Institute for Autism (SREIA) Parent Training Programme

The SREIA program is grounded in applied behavior analysis and developmental theories. It aims to reduce child behavioral problems and promote child development by improving parental attitudes and parenting styles. The program targets parent-child dyads from families of children with ASD aged between three and six years. It is delivered five days a week for 11 weeks. Fourteen two-hour lectures on weekly themes (such as knowledge of ASD, parent-child interaction, and behavior management techniques) are offered throughout the 11 weeks and attended by all participating parents. For the remaining time, additional training in ABA principles and practice are tailored for the different functioning groups. The program offers a combination of individual counselling and group sessions, as well as a mixture of didactic and interactive delivery modes. All sessions are delivered in person. Some sessions are only for parents and others are participated in by both parent and child.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Normal University

OTHER

Sponsor Role: collaborator

Beijing Stars and Rain Education Institute for Autism

UNKNOWN

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Stars and Rain Education Institute for Autism

Beijing, Beijing Municipality, China

Countries

China

References

Fang Z, Lachman JM, Qiao D, Barlow J. Controlled Trial of a Short-term Intensive Parent Training Program within the Context of Routine Services for Autistic Children in China. Psychosoc Interv. 2022 May 13;31(2):121-131. doi: 10.5093/pi2022a9. eCollection 2022 May.

Reference Type: DERIVED

PMID: 37360058 (View on PubMed)

Other Identifiers

R67619/RE001

Identifier Type: -

Identifier Source: org_study_id