Autism Spectrum DisorderNCT03725644
Parent Training Program for Preschool Children With Autism Spectrum Disorders
A study testing parent-training program and traditional program in people with Autism Spectrum Disorder, run by National Cheng Kung University.
Trial summary
Previous research has showed that parent-training programs derived from the developmental individual-difference relationship-based model (DIR) could improve the communicative development of children with autism spectrum disorder (ASD). However, the empirical evidence is weak. Read more about this study
- Who is it for?
- Ages 36 to 71 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- parent-training program and traditional program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 29 Jan 2015to 30 Sep 2017
- 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 36 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with a diagnosis of ASD according to the Diagnostic and Statistics Manual of Mental Disorders - Fifth edition (DSM-5; APA, 2013) by registered pediatric psychiatrists;
- mild to severe symptoms of ASD according to the Standard Version of Childhood Autism Rating Scale - Second edition (CARS2-ST; Schopler et al., 2010);
- children aged 36 to 71 months old;
- children whose primary caregivers (parents who cared for their child for over 15 hours per week - except during sleep time) used Mandarin as their main language;
- children whose caregivers' educational level were at or above middle school so that they could read manuals and complete the questionnaires.
Who cannot join
- children who attended other intensive interventions (e.g., 25 hours per week) or had been diagnosed with additional diseases or disorders;
- parents who attended other parent-training programs at the same time.
About this study
Official title: Effectiveness of Floortime Intervention Program for Preschool Children With Autism Spectrum Disorders
Previous research has showed that parent-training programs derived from the developmental individual-difference relationship-based model (DIR) could improve the communicative development of children with autism spectrum disorder (ASD). However, the empirical evidence is weak. This study therefore examines whether a DIR-based parent-training program can improve children's adaptive functioning and parents' parenting skills using a rigorous randomized controlled trial design with a dose-matched control group. Forty preschool children with autism spectrum disorder (ASD) and their parents were randomly assigned to the parent-training program group or the traditional program group at the pre-test phase. Both groups received 14-week intervention programs and were assessed using pre- and post-tests. Children's development levels and adaptive functioning were assessed by the Functional Emotional Assessment Scale (FEAS), the Chinese version of Psychoeducational Profile-third edition (CPEP-3), and the Vineland Adaptive Behavior Scales (VABS). In addition, parents' parenting skills were assessed by the FEAS and parenting stress was evaluated by the Parenting Stress Index-Short Form.
Read the detailed description
Introduction: Preschool children with autism spectrum disorder and their parents face many difficulties in daily lives, including children's adaptive functioning, parenting skills, and parenting stress. Therefore, effective and economical interventions are very important to support them. With appropriate theoretical bases, a parent-training program could be effective, economical, and feasible while the clinical manpower is insufficient. Among current intervention programs, the play concept and the developmental, individual difference, and relationship-based (DIR) model match the philosophy of occupational therapy. Previous research had showed the play- and DIR-based parent-training programs would improve children's communicative development. However, the empirical evidence was still weak due to poor research designs and little research was comprehensively investigated children's adaptive functioning. Moreover, the results of improvement in parenting skills and reduction of parenting stress were not consistent. Aim: This study would implement a dose-matched control group and comprehensive measurements to examine if the play- and DIR-based parent-training program would improve children's adaptive functioning and parents' parenting skills as well as reduce parenting stress. Hypotheses: We hypothesized that the better improvements would show in the parent-training program than those in the traditional program. Method: We recruited 40 preschool children with autism spectrum disorder and their parents and randomly assigned them to either the parent-training program group or the traditional program group after pretest phase. Both of them conducted 14-week intervention programs and were assessed after interventions. Children's development levels and adaptive functioning were assessed by the Functional Emotional Assessment Scale (FEAS), the Chinese version of Psychoeducational Profile-third edition (CPEP-3), and the Vineland Adaptive Behavior Scales (VABS). In addition, parents' parenting skills were assessed by the FEAS and parenting stress was evaluated by the Parenting Stress Index-Short Form.
- Conditions
- Autism Spectrum Disorder
- Being tested
- parent-training program, traditional program
- 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.
parent-training programBehavioural
Parents in the treatment group received the training program from the registered pediatric occupational therapist in six hours over three weeks. The occupational therapist provided suggestions and gave feedback. The parents were encouraged to interact with their children for at least 15 hours per week. Between the fourth and 14th weeks, the parents implemented the intervention programs at home and recorded the daily intensity. The occupational therapist met with the parents and children at monthly intervals (the seventh and 11th weeks) at the laboratory to discuss any difficulties they encountered and to practice the child-initiated activities.
traditional programBehavioural
Parents in the control group also conducted a 14-week program. They received six hours of training over three weeks.Between the fourth and 14th weeks, the parents implemented parent-led activities at home and recorded the daily intensity. The parents were encouraged to do activities with their children for at least 15 hours per week. The occupational therapist met with the parents at monthly intervals (the seventh and 11th weeks) at the laboratory to discuss any difficulties they encountered while practicing the parent-led activities.
| Study group | Role | What they receive |
|---|---|---|
| parent-training program | Experimental | Parents in the treatment group received the parent-training program based on the DIR model. The parent-training program encouraged child-initiated activities according to the functional developmental levels. The treatment intensity and duration were the same for both groups including 3-week courses and 11-week home programs. The investigators in this study are two registered pediatric occupational therapists who have at least five years of early intervention experience and had studied the DIR model. Receives: Behavioral: parent-training program |
| traditional program | Experimental | Parents in the control group received the traditional program based on the developmental approach. The traditional program provided parent-lead activities that fit child's developmental stage. Receives: Behavioral: traditional program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Scores of Functional Emotional Assessment Scale
The Functional Emotional Assessment Scale (FEAS; Greenspan et al., 2001) is based on six functional developmental levels of the developmental individual-difference relationship-based model and divided into two parts that (1) examine the children's development and (2) assess the parenting skills. All parents in the study were asked to record their parent-child activities as 15-minute videos. All videos were coded using random numbers to hide the research information (e.g. groups and test time). Two videos (pre- and post-test) were reviewed for each child. Using the Chinese version of the Scoring Form translated by Liao et al. (2014; intraclass correlation coefficient = 0.85), each item of the FEAS was rated as 0, 1 or 2. Higher raw scores represent better functions and skills. The total score is summed and ranges from 0 to 80.
Measured: 14 weeks
Secondary outcomes (2)
Change Scores of Chinese Version of Psychoeducational Profile - Third Edition
The performance scale of the Chinese Version of Psychoeducational Profile-3 (Schopler et al., 2005; Heep Hong Society, 2013) comprises six subtests for developmental abilities (cognitive verbal/preverbal, expressive language, receptive language, fine motor, gross motor and visual-motor imitation), which are summed to create communication and motor composites. The score of each item is rated as 0, 1 or 2. All six subtests for developmental abilities can be converted to age-equivalent and composite scores. The communication and motor composites scores range from 0 to 60. The higher the scores are, the better function the children achieve.
Measured: 14 weeks
Change Scores of Vineland Adaptive Behavior Scales
The Vineland Adaptive Behavior Scales (VABS; Sparrow et al., 1984) comprises four domains, that is, communication, daily living skills, socialization and motor skills, for assessing adaptive functioning in children aged 3 to 12 years old. The raw score in each domain and total raw score are converted to an age-equivalent score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The range for each subscale is from 20 to 140. The subscales are summed to compute a total score, ranging from 80 to 560. The higher the scores are, the better adaptive functioning the children achieve.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start29 Jan 2015
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
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 Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling-Yi Lin, National Cheng Kung University
- Investigators
- Ling Yi Lin, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725644
- Sponsor's protocol ID
- B-BR-103-065
- Status last verified
- Oct 2018
- First submitted
- 26 Oct 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
Liao ST, Hwang YS, Chen YJ, Lee P, Chen SJ, Lin LY. Home-based DIR/Floortime intervention program for preschool children with autism spectrum disorders: preliminary findings. Phys Occup Ther Pediatr. 2014 Nov;34(4):356-67. doi: 10.3109/01942638.2014.918074. Epub 2014 May 27.
PubMed 24865120
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Floortime Intervention Program for Preschool Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT03725644
- Acronym / sponsor ID
- B-BR-103-065
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 29 Jan 2015 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 31 Oct 2018 (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.
Previous research has showed that parent-training programs derived from the developmental individual-difference relationship-based model (DIR) could improve the communicative development of children with autism spectrum disorder (ASD). However, the empirical evidence is weak. This study therefore examines whether a DIR-based parent-training program can improve children's adaptive functioning and parents' parenting skills using a rigorous randomized controlled trial design with a dose-matched control group. Forty preschool children with autism spectrum disorder (ASD) and their parents were randomly assigned to the parent-training program group or the traditional program group at the pre-test phase. Both groups received 14-week intervention programs and were assessed using pre- and post-tests. Children's development levels and adaptive functioning were assessed by the Functional Emotional Assessment Scale (FEAS), the Chinese version of Psychoeducational Profile-third edition (CPEP-3), and the Vineland Adaptive Behavior Scales (VABS). In addition, parents' parenting skills were assessed by the FEAS and parenting stress was evaluated by the Parenting Stress Index-Short Form.
Detailed description
Introduction: Preschool children with autism spectrum disorder and their parents face many difficulties in daily lives, including children's adaptive functioning, parenting skills, and parenting stress. Therefore, effective and economical interventions are very important to support them. With appropriate theoretical bases, a parent-training program could be effective, economical, and feasible while the clinical manpower is insufficient. Among current intervention programs, the play concept and the developmental, individual difference, and relationship-based (DIR) model match the philosophy of occupational therapy. Previous research had showed the play- and DIR-based parent-training programs would improve children's communicative development. However, the empirical evidence was still weak due to poor research designs and little research was comprehensively investigated children's adaptive functioning. Moreover, the results of improvement in parenting skills and reduction of parenting stress were not consistent. Aim: This study would implement a dose-matched control group and comprehensive measurements to examine if the play- and DIR-based parent-training program would improve children's adaptive functioning and parents' parenting skills as well as reduce parenting stress. Hypotheses: We hypothesized that the better improvements would show in the parent-training program than those in the traditional program. Method: We recruited 40 preschool children with autism spectrum disorder and their parents and randomly assigned them to either the parent-training program group or the traditional program group after pretest phase. Both of them conducted 14-week intervention programs and were assessed after interventions. Children's development levels and adaptive functioning were assessed by the Functional Emotional Assessment Scale (FEAS), the Chinese version of Psychoeducational Profile-third edition (CPEP-3), and the Vineland Adaptive Behavior Scales (VABS). In addition, parents' parenting skills were assessed by the FEAS and parenting stress was evaluated by the Parenting Stress Index-Short Form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parent-training program | Experimental | Behavioral: parent-training programParents in the treatment group received the parent-training program based on the DIR model. The parent-training program encouraged child-initiated activities according to the functional developmental levels. The treatment intensity and duration were the same for both groups including 3-week courses and 11-week home programs. The investigators in this study are two registered pediatric occupational therapists who have at least five years of early intervention experience and had studied the DIR model. |
| traditional program | Experimental | Behavioral: traditional programParents in the control group received the traditional program based on the developmental approach. The traditional program provided parent-lead activities that fit child's developmental stage. |
Who may qualify
- Ages
- 36 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children with a diagnosis of ASD according to the Diagnostic and Statistics Manual of Mental Disorders - Fifth edition (DSM-5; APA, 2013) by registered pediatric psychiatrists;
- mild to severe symptoms of ASD according to the Standard Version of Childhood Autism Rating Scale - Second edition (CARS2-ST; Schopler et al., 2010);
- children aged 36 to 71 months old;
- children whose primary caregivers (parents who cared for their child for over 15 hours per week - except during sleep time) used Mandarin as their main language;
- children whose caregivers' educational level were at or above middle school so that they could read manuals and complete the questionnaires.
Key exclusion criteria (2 listed)
- children who attended other intensive interventions (e.g., 25 hours per week) or had been diagnosed with additional diseases or disorders;
- parents who attended other parent-training programs at the same time.
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 |
|---|---|---|
| parent-training programParents in the treatment group received the training program from the registered pediatric occupational therapist in six hours over three weeks. The occupational therapist provided suggestions and gave feedback. The parents were encouraged to interact with their children for at least 15 hours per week. Between the fourth and 14th weeks, the parents implemented the intervention programs at home and recorded the daily intensity. The occupational therapist met with the parents and children at monthly intervals (the seventh and 11th weeks) at the laboratory to discuss any difficulties they encountered and to practice the child-initiated activities. | Behavioural | parent-training program |
| traditional programParents in the control group also conducted a 14-week program. They received six hours of training over three weeks.Between the fourth and 14th weeks, the parents implemented parent-led activities at home and recorded the daily intensity. The parents were encouraged to do activities with their children for at least 15 hours per week. The occupational therapist met with the parents at monthly intervals (the seventh and 11th weeks) at the laboratory to discuss any difficulties they encountered while practicing the parent-led activities. | Behavioural | traditional program |
Primary outcome
Change Scores of Functional Emotional Assessment Scale
Time frame: 14 weeks
The Functional Emotional Assessment Scale (FEAS; Greenspan et al., 2001) is based on six functional developmental levels of the developmental individual-difference relationship-based model and divided into two parts that (1) examine the children's development and (2) assess the parenting skills. All parents in the study were asked to record their parent-child activities as 15-minute videos. All videos were coded using random numbers to hide the research information (e.g. groups and test time). Two videos (pre- and post-test) were reviewed for each child. Using the Chinese version of the Scoring Form translated by Liao et al. (2014; intraclass correlation coefficient = 0.85), each item of the FEAS was rated as 0, 1 or 2. Higher raw scores represent better functions and skills. The total score is summed and ranges from 0 to 80.
2 secondary outcomes
Change Scores of Chinese Version of Psychoeducational Profile - Third Edition
Time frame: 14 weeks
Change Scores of Vineland Adaptive Behavior Scales
Time frame: 14 weeks
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 31 Oct 2018.
- Results publication: PubMed 24865120Liao ST, Hwang YS, Chen YJ, Lee P, Chen SJ, Lin LY. Home-based DIR/Floortime intervention program for preschool children with autism spectrum disorders: preliminary findings. Phys Occup Ther Pediatr. 2014 Nov;34(4):356-67. doi: 10.3109/01942638.2014.918074. Epub 2014 May 27.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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.
Ling Yi Lin principal investigator
National Cheng Kung University
Questions about this trial
What is this clinical trial studying?
A study testing parent-training program and traditional program in people with Autism Spectrum Disorder, run by National Cheng Kung University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Scores of Functional Emotional Assessment Scale (time frame: 14 weeks). 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 NCT03725644, 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 31 Oct 2018.