Child Behavior ProblemSREIANCT04257331
Parent Training to Reduce Behavioral Problems in Children With Autism Spectrum Disorder in China
A study testing Stars and Rain Education Institute for Autism (SREIA) Parent Training Programme in people with Child Behavior Problem and Autism Spectrum Disorder, run by University of Oxford at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Child Behavior Problem, Autism Spectrum Disorder, Parent-Child Relations
- What is being tested?
- Stars and Rain Education Institute for Autism (SREIA) Parent Training Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 12 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Stars and Rain Education Institute for Autism
Beijing, Beijing Municipality, 100121
About this study
Official title: Evaluation of a Parent Training Programme for Families of Children With Autism Spectrum Disorder in China: A Mixed-Methods Quasi-Experimental Study
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.
Read more
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
- Being tested
- Stars and Rain Education Institute for Autism (SREIA) Parent Training Programme
- Keywords
- Parenting Education, Quasi Experimental Design, Propensity Score Weight
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stars and Rain Education Institute for Autism (SREIA) Parent Training ProgrammeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Differences between groups within 1 month after the end of intervention
Secondary outcomes (6)
Change in frequency of ASD symptoms
ASD symptoms will be assessed using the Chinese version of the Autism Treatment Evaluation Checklist (ATEC), which comprise four subscales to measure child speech/language/communication, sociability, sensory/cognitive awareness, and health/physical/behavior. The scale has 77 items that are scored by parents. The health/physical/behavior subscale is rated using a 0 (not a problem)-to-3 (serious problem) point scale, whereas the other three subscales are rated using a 0 (not true)-to-2 (very true) point scale. Higher scores represent more ASD symptoms.
Measured: Differences between groups within 1 month after the end of intervention
Change in frequency of parenting style: over-reactivity
Over-reactivity parenting style will be measured using the Over-Reactivity subscale (5 items) of the Arnold-O'Leary Parenting Scale (PS). The PS assesses dysfunctional discipline practices reported by parents using a 7-point Likert-type scale. Higher scores indicate more dysfunctional parenting practices.
Measured: Differences between groups within 1 month after the end of intervention
Change in frequency of parenting style: supportive behaviors
Supportive parenting style will be measured using the Supporting Positive Behavior subscale (7 items) of the Parenting Young Children Scale (PARYC). The PARYC Supporting Positive Behavior subscale is rated by parents from 1 to 7 regarding the frequency with which they engaged in such parenting strategies during the last month. Higher scores represent more positive and proactive parenting practices. Higher scores indicate more supportive parenting practices.
Measured: Differences between groups within 1 month after the end of intervention
Change in frequency of parental mental health symptoms
Parental mental health will be assessed using the Depression Anxiety Stress Scale-21 items (DASS-21), which consists of three self-report subscales (depression, anxiety, and stress) with each having 7 items that are rated from 0 (not apply to me) to 3 (apply to me very much or most of the time). Higher scores indicate a worse emotional state.
Measured: Differences between groups within 1 month after the end of intervention
Change in family function
Family function will be assessed using the Chinese version of the Family APGAR scale, which consists of 5 items that are rated from 0 (never) to 2 (often) to examine the five functional components of adaptability, partnership, growth, affection, and resolve. Higher scores indicate that parents are more satisfied with their relationships with other family members.
Measured: Differences between groups within 1 month after the end of intervention
Change in parental knowledge
Parental knowledge will be measured using of a questionnaire designed for the SREIA evaluation to assess parental understanding of ASD and child behaviors.
Measured: Differences between groups within 1 month after the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Sep 2020
- Primary completion31 Dec 2020
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child Behavior ProblemStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Normal University, Beijing Stars and Rain Education Institute for Autism
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257331
- Sponsor's protocol ID
- R67619/RE001
- Acronym
- SREIA
- Status last verified
- Apr 2022
- First submitted
- 30 Jan 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not publicly available due to ethical requirements in the University of Oxford but will be available from the corresponding author on reasonable request.
Publications
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.
PubMed 37360058
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Parent Training Programme for Families of Children With Autism Spectrum Disorder in China: A Mixed-Methods Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT04257331
- Acronym / sponsor ID
- SREIA / R67619/RE001
- Conditions
- Child Behavior Problem, Autism Spectrum Disorder, Parent-Child Relations, Parenting, Mental Health Issue, Child Abuse
- Keywords
- Parenting Education, Quasi Experimental Design, Propensity Score Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Beijing Normal University, Beijing Stars and Rain Education Institute for Autism
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SREIA group | Experimental | Behavioral: Stars and Rain Education Institute for Autism (SREIA) Parent Training ProgrammeParticipants in this arm will be families who attend the first wave of the two rounds of delivery. They will be the intervention group. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stars and Rain Education Institute for Autism (SREIA) Parent Training ProgrammeThe 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. | Behavioural | SREIA group |
Primary outcome
Change in frequency of child ehavioral problems
Time frame: Differences between groups within 1 month after the end of intervention
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.
6 secondary outcomes
Change in frequency of ASD symptoms
Time frame: Differences between groups within 1 month after the end of intervention
Change in frequency of parenting style: over-reactivity
Time frame: Differences between groups within 1 month after the end of intervention
Change in frequency of parenting style: supportive behaviors
Time frame: Differences between groups within 1 month after the end of intervention
Change in frequency of parental mental health symptoms
Time frame: Differences between groups within 1 month after the end of intervention
Change in family function
Time frame: Differences between groups within 1 month after the end of intervention
Change in parental knowledge
Time frame: Differences between groups within 1 month after the end of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 37360058Fang 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.
- Individual participant dataSharing planned: No. The data will not publicly available due to ethical requirements in the University of Oxford but will be available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stars and Rain Education Institute for Autism (SREIA) Parent Training Programme in people with Child Behavior Problem and Autism Spectrum Disorder, run by University of Oxford at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of child ehavioral problems (time frame: Differences between groups within 1 month after the end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04257331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022; AzTrials last refreshed its copy on 29 Oct 2026.