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

NCT04257331 | Completed

• 1 other identifier: R67619/RE001
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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

Keywords

Parenting Education; Quasi Experimental Design; Propensity Score Weight

Outcome Measures

Primary Outcomes (1)

• Change in frequency of child ehavioral problems

  Child behavioral problems will be assessed using the Externalizing scale of the Child Behavior Checklist (CBCL) for Ages 1.5-5. The Externalizing scale measures child attention problems and aggressive behaviors using 24 items rated by parents based on child performance during the previous two months with a 3-point -type scale. The study will use the CBCL 1.5-5 for all families whose children will be between three to six years old. Lower scores suggest fewer behavioral problems. Research has shown sufficient test-retest reliability, internal consistency, convergent validity, and cross-cultural validity of CBCL 2-3 and CBCL 4-18 in China, but the evidence regarding the validity and reliability of this new version of CBCL 1.5-5 is currently limited. However, the CBCL 1.5-5 has shown good factorial validity among Chinese girls adopted into North American families; it has also demonstrated good internal validity with children with ASD.

  Differences between groups within 1 month after the end of intervention

Secondary Outcomes (6)

• Change in frequency of ASD symptoms

  Differences between groups within 1 month after the end of intervention

• Change in frequency of parenting style: over-reactivity

  Differences between groups within 1 month after the end of intervention

• Change in frequency of parenting style: supportive behaviors

  Differences between groups within 1 month after the end of intervention

• Change in frequency of parental mental health symptoms

  Differences between groups within 1 month after the end of intervention

• Change in family function

  Differences between groups within 1 month after the end of intervention

Other Outcomes (7)

• Parent satisfaction: questionnaire

  Within 1 month after the end of intervention

• Participant involvement

  During the intervention

• Implementation fidelity

  During the intervention

Study Arms (2)

SREIA group

EXPERIMENTAL

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

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

Waitlist Control

NO INTERVENTION

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

Interventions

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

SREIA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• Beijing Normal University: collaborator
• Beijing Stars and Rain Education Institute for Autism: collaborator

Study Sites (1)

Beijing Stars and Rain Education Institute for Autism

Beijing, Beijing Municipality, 100121, China

Location

Related Publications (1)

• 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.

  PMID: 37360058 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Stars, Celestial

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Astronomical Objects; Astronomical Phenomena; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of parent training and the use of a waitlist control group, it will not be possible to blind participants or facilitators. However, research staff who collect the data will be blinded for the baseline and post-intervention assessment. Data collectors will not be involved in the delivery process and will be trained on the topic of risk of bias. Parents will also be asked not to reveal their allocation condition to outcome data collectors. Process evaluation data will be collected by a separate group of research staff. Given that all families will ultimately receive the training, blinding will not be possible at the follow-up time-points. Blinding will be protected and monitored, while the violation of blinding will be detected and incorporated into the interpretation of results.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 6, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: October 12, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)