Autism Spectrum DisorderNCT04339153
Feasibility Study on Parents Skill Training Program for Reducing Parental Distress and Disruptive Behavior of Their Children With Autism Spectrum Disorder (ASD)
A study testing Parent Training for Disruptive Behaviours in people with Autism Spectrum Disorder and Disruptive Behaviours, run by Foundation University Islamabad.
Trial summary
Children with Autism Spectrum Disorder (ASD) usually exhibt problematic behavioral issues such as hitting, non-compliance, tantrums, spitting, headbanging and aggression, this not only cause distress for the child but also has a significant effect on the mental health of the parents. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Disruptive Behaviours
- What is being tested?
- Parent Training for Disruptive Behaviours
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2020to 2 Sep 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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 3 to 9 years will be recruited. The gold standard diagnostic tools i.e. the autism diagnostic observation schedule (ADOS) will be administered by a trained assessor to confirm the diagnosis of ASD.
- To ensure our intervention reaches children with behavioural difficulties, children who will score > 15 on the subscale of Irritability ABC-C will be included.
Who cannot join
- Potential participants with an intellectual disability and non-receptive, or who have a severe medical illness will be excluded from the study.
- Although unlikely to occur, children with ASD whose parents have received any intensive parent training during the past 24 months will not be included
Trial locations and contacts
No sites are listed yet.
Nasim Chaudhry, Dr. Prof. contact
About this study
Children with Autism Spectrum Disorder (ASD) usually exhibt problematic behavioral issues such as hitting, non-compliance, tantrums, spitting, headbanging and aggression, this not only cause distress for the child but also has a significant effect on the mental health of the parents.
In Pakistan, the rise in ASD children, lack of resources, non-advocacy, and limited knowledge amongst health professionals have created an alarming situation not only psychologically but also because of the economic burden. The current study is to assess the impact of a psychoeducation and parental skills training programme for reducing the parental psychological stress and disruptive behavior of their children with Autism. This is a 24 weeks parent education and behavioural management manualized programme based on the principles of applied behavior analysis.
Read more
The plan will include skills training on replacing problematic behaviours with more appropriate behaviours, improving social communication in verbal and non-verbal children, and interactions with peers and others. The parents will be trained on the manualized training programme in groups or as individual sessions using modelling, role-plays and rehearsal as training methods. A total of 60 parents of ASD children, age ranges from 3 to 9 years with disruptive behaviour will be recruited. The diagnosed ASD children screened from the standardised instruments not later than six months and scored > 15 on the subscale Irritability of Aberrant Behaviour Checklist will be randomly divided into two groups, 1) parents receiving manualized training program 2) parents receiving education sessions. The baseline will be determined baseline by using parent-rated instruments for behavioural problems using the Aberrant Behaviour Checklist, Home Situation Questionnaire, Vineland Adaptive behaviour scales, Symptom Checklist 90, and Parental Distress Index. Overall there will be 12 core sessions on the Parental Education (PE) pertaining to parent education including advocacy and educational planning over 24 weeks and 11 sessions of Parent Training (PT) for managing behavioural issues of autistic children. Each session will last for 60 to 90 minutes. There will be six months follow up, and evaluation will be done by the masked assessor. All the sessions will be from a trained psychologist and behaviour analysts who have more than 1 year experience of working with children with ASD. To ensure treatment integrity, all training sessions will be assessed after every 4 weeks by using behavioural measures to evaluate the correct implementation of treatment protocol. Some of the sessions will be recorded.
It is anticipated that parent training will improve the mental health of parents and reduce the disruptive behaviour of children with Autism Spectrum Disorder.
- Conditions
- Autism Spectrum Disorder, Disruptive Behaviours
- Being tested
- Parent Training for Disruptive Behaviours
- 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 for Disruptive BehavioursBehavioural
Critically, PT also involves education about autism during the initial sessions, and thus benefits of PT are inferred to come from the specific training.
| Study group | Role | What they receive |
|---|---|---|
| Parent Training (PT) | Experimental | The goal of intervention plan is to teach the basic applied behaviour analysis techniques to find out the antecedent of the problem behaviour, enhance adaptive skills and reduce noncompliance. Sessions will be interactive, and action-oriented through the provision of workbooks, modelling, videos, rehearsal (with child when present), homework tasks, and feedback (Bearss et al., 2015). The parents will be trained on the protocol and delivered 60 to 90 minutes preferably individual sessions over 24 weeks. Receives: Behavioral: Parent Training for Disruptive Behaviours |
| Parent Education (PE) | No intervention | The Parent education group will serve as an attention-placebo condition to control for general effects of the intervention. There will be 12 core sessions and 1 home visit regarding knowledge of autism, learning about the principles of managing behavior, teaching new skills; improving social interaction and communication. Each session will last for 60 to 90 minutes over 24 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist-Community (ABC-C; Aman & Singh, 1994)
The ABC is an informant scale rated 0 to 3 for assessing problem behaviour scales. Its subscales and respective numbers of items are as follows: 1. Irritability (15 items), 2. Social Withdrawal (16 items), 3. Stereotypic Behavior (7 items), 4. Hyperactivity/Noncompliance (16 items), and 5. Repetitive Speech (4 items).
Measured: 24 weeks
Parenting Stress Index, Fourth Edition Short Form (PSI-4; Abidin, 1995)
It is a 120-item measure used to examine parental stress levels considering a parent's relationship with one of his or her children between the ages of 1 month and 12 years. There are three domains i.e, (a) child characteristics, (b) parent characteristics, and (c) situational/demographic life stress.
Measured: 24 weeks
Symptom Checklist-90 (SCL-90, Derogatis, Rickels, Rock, 1976)
The SCL-90 will be used to measure the psychological distress. It is also a valid measure of screening nine symptoms including somatization, hostility, depression, anxiety, interpersonal sensitivity, social anxiety, paranoia, obsessive compulsive and agoraphobia. Sum of all the subscales indicate the psychological distress and having .98 reliability which is highly satisfactory.
Measured: 24 weeks
Secondary outcomes (3)
Vineland Adaptive Behavior Scales (Vineland-II; Sparrow, Cicchetti, & Balla, 2005)
It is used to evaluate the four broad domains including communication, daily living skills, socialization and motor skills. It also includes an optional scale to assess maladaptive behaviour.
Measured: 24 weeks
Home Situations Questionnaire Disorder (HSQ; Chowdhury et al, 2016)
It is a 24-item parent rating scale from 1 (mild) to 9 (severe). It is designed to evaluate noncompliance in children with ASD.
Measured: 24 weeks
Clinical Global Impressions - Improvement Scale (CGI; Guy 1976)
It is a 7-point scale designed to measure overall improvement from baseline. Scores range from 1 (very much improved) through 4 (unchanged) to 7 (very much worse). Scores of 1 or 2 at week 24 endpoint identified clinical responders.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start2 Apr 2020 (estimated)
- Primary completion2 Sep 2021 (estimated)
- Study completion2 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- The study is a Randomized Controlled Trial (RCT) with single blind rating. The participants will be randomly divided into two groups. One group will receive the Parent Training (PT) and the other will get the Parent Education (PE).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Shafique, Dr, Principal investigator, FUINasim Chaudhary, Dr. Prof., Study chair, FUINusrat Hussain, Dr. Prof., Principal investigator, University of ManchesterJumana Ahmad, Principal investigator, Greenwich University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339153
- Sponsor's protocol ID
- FUI/CTR/2020/2
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on Parents Skill Training Program for Reducing Parental Distress and Disruptive Behavior of Their Children With Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT04339153
- Acronym / sponsor ID
- FUI/CTR/2020/2
- Conditions
- Autism Spectrum Disorder, Disruptive Behaviours
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 2 Apr 2020 (estimated)
- Primary completion
- 2 Sep 2021 (estimated)
- Study completion
- 2 Sep 2021 (estimated)
- First posted
- 9 Apr 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.
Children with Autism Spectrum Disorder (ASD) usually exhibt problematic behavioral issues such as hitting, non-compliance, tantrums, spitting, headbanging and aggression, this not only cause distress for the child but also has a significant effect on the mental health of the parents.
In Pakistan, the rise in ASD children, lack of resources, non-advocacy, and limited knowledge amongst health professionals have created an alarming situation not only psychologically but also because of the economic burden. The current study is to assess the impact of a psychoeducation and parental skills training programme for reducing the parental psychological stress and disruptive behavior of their children with Autism. This is a 24 weeks parent education and behavioural management manualized programme based on the principles of applied behavior analysis.
The plan will include skills training on replacing problematic behaviours with more appropriate behaviours, improving social communication in verbal and non-verbal children, and interactions with peers and others. The parents will be trained on the manualized training programme in groups or as individual sessions using modelling, role-plays and rehearsal as training methods. A total of 60 parents of ASD children, age ranges from 3 to 9 years with disruptive behaviour will be recruited. The diagnosed ASD children screened from the standardised instruments not later than six months and scored > 15 on the subscale Irritability of Aberrant Behaviour Checklist will be randomly divided into two groups, 1) parents receiving manualized training program 2) parents receiving education sessions. The baseline will be determined baseline by using parent-rated instruments for behavioural problems using the Aberrant Behaviour Checklist, Home Situation Questionnaire, Vineland Adaptive behaviour scales, Symptom Checklist 90, and Parental Distress Index. Overall there will be 12 core sessions on the Parental Education (PE) pertaining to parent education including advocacy and educational planning over 24 weeks and 11 sessions of Parent Training (PT) for managing behavioural issues of autistic children. Each session will last for 60 to 90 minutes. There will be six months follow up, and evaluation will be done by the masked assessor. All the sessions will be from a trained psychologist and behaviour analysts who have more than 1 year experience of working with children with ASD. To ensure treatment integrity, all training sessions will be assessed after every 4 weeks by using behavioural measures to evaluate the correct implementation of treatment protocol. Some of the sessions will be recorded.
It is anticipated that parent training will improve the mental health of parents and reduce the disruptive behaviour of children with Autism Spectrum Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a Randomized Controlled Trial (RCT) with single blind rating. The participants will be randomly divided into two groups. One group will receive the Parent Training (PT) and the other will get the Parent Education (PE).
| Arm | Type | Receives |
|---|---|---|
| Parent Training (PT) | Experimental | Behavioral: Parent Training for Disruptive BehavioursThe goal of intervention plan is to teach the basic applied behaviour analysis techniques to find out the antecedent of the problem behaviour, enhance adaptive skills and reduce noncompliance. Sessions will be interactive, and action-oriented through the provision of workbooks, modelling, videos, rehearsal (with child when present), homework tasks, and feedback (Bearss et al., 2015). The parents will be trained on the protocol and delivered 60 to 90 minutes preferably individual sessions over 24 weeks. |
| Parent Education (PE) | No intervention | –The Parent education group will serve as an attention-placebo condition to control for general effects of the intervention. There will be 12 core sessions and 1 home visit regarding knowledge of autism, learning about the principles of managing behavior, teaching new skills; improving social interaction and communication. Each session will last for 60 to 90 minutes over 24 weeks. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 3 to 9 years will be recruited. The gold standard diagnostic tools i.e. the autism diagnostic observation schedule (ADOS) will be administered by a trained assessor to confirm the diagnosis of ASD.
- To ensure our intervention reaches children with behavioural difficulties, children who will score > 15 on the subscale of Irritability ABC-C will be included.
Key exclusion criteria (2 listed)
- Potential participants with an intellectual disability and non-receptive, or who have a severe medical illness will be excluded from the study.
- Although unlikely to occur, children with ASD whose parents have received any intensive parent training during the past 24 months will not be included
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 for Disruptive BehavioursCritically, PT also involves education about autism during the initial sessions, and thus benefits of PT are inferred to come from the specific training. | Behavioural | Parent Training (PT) |
Primary outcome
Aberrant Behavior Checklist-Community (ABC-C; Aman & Singh, 1994)
Time frame: 24 weeks
The ABC is an informant scale rated 0 to 3 for assessing problem behaviour scales. Its subscales and respective numbers of items are as follows: 1. Irritability (15 items), 2. Social Withdrawal (16 items), 3. Stereotypic Behavior (7 items), 4. Hyperactivity/Noncompliance (16 items), and 5. Repetitive Speech (4 items).
Parenting Stress Index, Fourth Edition Short Form (PSI-4; Abidin, 1995)
Time frame: 24 weeks
It is a 120-item measure used to examine parental stress levels considering a parent's relationship with one of his or her children between the ages of 1 month and 12 years. There are three domains i.e, (a) child characteristics, (b) parent characteristics, and (c) situational/demographic life stress.
Symptom Checklist-90 (SCL-90, Derogatis, Rickels, Rock, 1976)
Time frame: 24 weeks
The SCL-90 will be used to measure the psychological distress. It is also a valid measure of screening nine symptoms including somatization, hostility, depression, anxiety, interpersonal sensitivity, social anxiety, paranoia, obsessive compulsive and agoraphobia. Sum of all the subscales indicate the psychological distress and having .98 reliability which is highly satisfactory.
3 secondary outcomes
Vineland Adaptive Behavior Scales (Vineland-II; Sparrow, Cicchetti, & Balla, 2005)
Time frame: 24 weeks
Home Situations Questionnaire Disorder (HSQ; Chowdhury et al, 2016)
Time frame: 24 weeks
Clinical Global Impressions - Improvement Scale (CGI; Guy 1976)
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Nasim Chaudhry, Dr. Prof. contact
Nadia Shafique, Dr principal investigator
FUI
Nasim Chaudhary, Dr. Prof. study chair
FUI
Nusrat Hussain, Dr. Prof. principal investigator
University of Manchester
Questions about this trial
What is this clinical trial studying?
A study testing Parent Training for Disruptive Behaviours in people with Autism Spectrum Disorder and Disruptive Behaviours, run by Foundation University Islamabad.
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 2 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: status not confirmed, as of the sponsor's last update on 9 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadia Shafique, PhD (03335513401, nadiashafique17@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant Behavior Checklist-Community (ABC-C; Aman & Singh, 1994) (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2020.