Autism Spectrum DisorderNCT03805828
Effectiveness of Educational Program on Parenting Stress and Coping Mechanism Among Parents of Children With Autism Spectrum Disorder in Amman, Jordan
A study testing Educational program on parenting stress and coping mechanism in people with Autism Spectrum Disorder, run by Universiti Putra Malaysia at 2 sites in Jordan.
Trial summary
Health and well being of children are inextricably linked to the physical, emotional and psychological of their parents. Autism Spectrum Disorder is one of the neurological developmental disorders characterized by moderate to severe impairments in social interactions, language, and cognitive development, as well as… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Educational program on parenting stress and coping mechanism
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesJordan
- Study dates
- 1 Mar 2019to 1 Aug 2019
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participant's inclusion eligibility criteria:
- Father or mother of a child who diagnosed for the period of three years since the initial time of diagnosis
- Father or mother who provides care and living together with the child
- Father or mother has the ability to read and write Arabic, and (4) father or mother age above 20 years old
- The center's inclusion eligibility criteria:
- Center provides caring only for ASD child with age 12 years and younger
- Provide the following services: speech, language, occupational, physiotherapy, educational, nutrition and medical services.
Who cannot join
- The participant's exclusion eligibility criteria
- Father or mother whose child had other chronic or illnesses (e.g, type 1 diabetes, down syndrome, learning disabilities, fetal alcohol syndrome)
- Foreign father or mother of a child with ASD residents in Amman
- Father or mother who previously participated in the intervention research (e.g, Cognitive Behavior Therapy, Mindfulness-Based Intervention)
- Father or mother of a child who takes any pharmacologic management of ASD (e.g,Risperdal, Ritalin)
- Father or mother with more than one child diagnosed with ASD
- The center's exclusion eligibility criteria
- Center doesn't include a suitable classroom for implementing the intervention program
Trial locations and contacts
2 sites in 1 country.
Jordan2 sites, 2 recruiting
- Not yet recruiting
Centers for the treatment of Autistic Disorder
Amman
- Recruiting
Ministry of Social Development
Amman
About this study
Official title: The Effectiveness of an Educational Program on Parenting Stress and Coping Mechanism Among Parents of Children With Autism Spectrum Disorder in Amman, Jordan
Health and well being of children are inextricably linked to the physical, emotional and psychological of their parents. Autism Spectrum Disorder is one of the neurological developmental disorders characterized by moderate to severe impairments in social interactions, language, and cognitive development, as well as included repetitive behaviors, restricted interests, and emotional distress. Coping with a stressful situation is classified as one of the most challenges in one's life. The overall aim of this study is to examine the effectiveness of the educational program on parenting stress and coping mechanism among parents of children with ASD in Amman, Jordan at baseline, post-test and at two months follow-up assessment. Two hundred parents of children with Autism spectrum disorder will be assigned to the intervention group (n = 100) and the control group (n = 100). Measures of parent stress and coping mechanism using the parent stress index(PSI) and Brief COPE will administer at pre-, post-treatment, and 2-months follow-up.
Read the detailed description
Background: Health and well being of children are inextricably linked to the physical, emotional and psychological of their parents. Maintaining the health and well-being of parents is a precondition for the best optimal care of their children with Autism Spectrum Disorder (ASD). The overall aim of the current study is to evaluate the effectiveness of an educational program on parenting stress and coping mechanism among parents of children with ASD in Jordan.
Methods: A cluster randomized controlled trial will be conducted in 4 private centers for the treatment of Autistic Disorder in Amman, Jordan. Inclusion criteria: father or mother of a child who diagnosed for the period of three years since the initial time of diagnosis, father or mother who provides care and living together with the child, father or mother has the ability to read and write Arabic, father or mother age above 20 years old,and center provides caring just for ASD child with age 12 years and younger. Exclusion criteria: father or mother whose child had other chronic or illnesses (e.g, type 1 diabetes, down syndrome, learning disabilities, fetal alcohol syndrome), foreign father or mother of a child with ASD residents in Amman, father or mother who previously participated in the intervention research (e.g, Cognitive Behavior Therapy, Mindfulness-Based Intervention), father or mother of a child who takes any pharmacologic management of ASD (e.g,Risperdal, Ritalin), father or mother with more than one child diagnosed with ASD,and center doesn't include a suitable classroom for implementing the intervention program. The educational intervention program will deliver to the intervention group as a one-day event in four sessions. Whereas, the control group will receive education about the communicable disease among childhood. With an estimated effect design of 1.3, a cluster size of 4 and 20% non-completion, the trial will need to enroll 200 participants. The primary outcomes of the current study are parenting stress and coping mechanism scores, which will be assessed using the Parent Stress Index-Short Form and Brief COPE, respectively. parenting stress and coping mechanism scores will be assessed at pre-intervention, post-intervention and follow-ups at week 8.
Results: The parenting stress and the coping mechanism will be compared between the intervention and control groups using A 2×3 repeated measure ANOVA.
Conclusions: Hypothesize that primary outcomes will improve significantly after the intervention compared to the control group. The finding from this study will determine the effectiveness of the educational program on parenting stress and coping mechanism among Jordanian parents of children with ASD. If proven to be effective, the educational program can serve as a part of therapeutic plan support to reduce parenting stress and improve coping mechanism.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Educational program on parenting stress and coping mechanism
- Keywords
- Autism spectrum disorder, parenting stress, coping mechanism, coping strategies, education program, educational intervention
- 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.
Educational program on parenting stress and coping mechanismOther
The educational program will deliver as a one-day event in four sessions: (1)background of autism spectrum disorder(ASD) and coping mechanism,(2) targeting communication and social difficulties among ASD children using coping mechanism,(3) targeting behavior problems among ASD children using coping mechanism, and (4) stress management as coping mechanism. The contents of the educational program deliver through the use of PowerPoint slides, Whiteboard and marker, practical exercise, video clips followed by group discussion and provision a hard copy booklet containing all items which were supposed to discuss. As well as each session will approximately be taken one hour. Each group will consist of 10 participants.
| Study group | Role | What they receive |
|---|---|---|
| Expermental | Experimental | In the intervention group, the educational program will deliver as a one-day event in four sessions: (1)background of autism spectrum disorder(ASD) and coping mechanism,(2) targeting communication and social difficulties among ASD children using coping mechanism,(3) targeting behavior problems among ASD children using coping mechanism, and (4) stress management as coping mechanism. Receives: Other: Educational program on parenting stress and coping mechanism |
| Control | Active comparator | In the control group, the educational about communicable disease among childhood deliver as a one-day event in four sessions: (1) introduction and background communicable disease of childhood,(2) communicable diseases of childhood (Chicken Pox, Diphtheria,and pertussis[a whooping cough]),(3) communicable diseases of childhood (Measles,Mumps,rubella[German Measles]and Poliomyelitis(,and (4) infection control. Receives: Other: Educational program on parenting stress and coping mechanism |
What is being measured
The primary outcome is the main question the study is designed to answer.
parenting stress
Self reported 36 statements on three subscales: parental distress (PD), parent-child dysfunctional interaction (P-CDI), and difficulty of the child (DC). Each subscale contains 12 items. The PSI-SF rated on a 5-point Likert scale, include 1 (strongly disagree) , 2 ( disagree ), 3 ( not sure ), 4 (agree) 5 (strongly agree), total scores range from 36 to 180. On the PSI-SF, stress levels considered normal with less than 90 scores , whereas , high-stress considered at or above the 90 scores
Measured: Mean change in scores of parenting stress from baseline to endpoint(two months follow-up) assessment
coping mechanism
self-administered questionnaire twenty-eight items of the Brief COPE are grouped into fourteen subscales containing two items for each: acceptance, active coping, planning, behavioral disengagement, denial, substance use, humor, positive reframing, religious coping, self-blame, self-distraction, use of emotional support, use of instrumental support, and venting emotions . The items of subscale rated on a four-point Likert scale with a response for each item ranging from 1 ( I haven't been doing this at all ) to 4 (I have been doing this a lot)
Measured: Mean change in scores of coping mechanism from baseline to endpoint(two months follow-up) assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Mar 2019 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2019 (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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haytham Mohammad Al-Oran, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805828
- Sponsor's protocol ID
- University Putra Malaysia
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2019
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary outcomes measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Educational Program on Parenting Stress and Coping Mechanism Among Parents of Children With Autism Spectrum Disorder in Amman, Jordan
- ClinicalTrials.gov ID
- NCT03805828
- Acronym / sponsor ID
- University Putra Malaysia
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism spectrum disorder, parenting stress, coping mechanism, coping strategies, education program, educational intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 16 Jan 2019 (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.
Health and well being of children are inextricably linked to the physical, emotional and psychological of their parents. Autism Spectrum Disorder is one of the neurological developmental disorders characterized by moderate to severe impairments in social interactions, language, and cognitive development, as well as included repetitive behaviors, restricted interests, and emotional distress. Coping with a stressful situation is classified as one of the most challenges in one's life. The overall aim of this study is to examine the effectiveness of the educational program on parenting stress and coping mechanism among parents of children with ASD in Amman, Jordan at baseline, post-test and at two months follow-up assessment. Two hundred parents of children with Autism spectrum disorder will be assigned to the intervention group (n = 100) and the control group (n = 100). Measures of parent stress and coping mechanism using the parent stress index(PSI) and Brief COPE will administer at pre-, post-treatment, and 2-months follow-up.
Detailed description
Background: Health and well being of children are inextricably linked to the physical, emotional and psychological of their parents. Maintaining the health and well-being of parents is a precondition for the best optimal care of their children with Autism Spectrum Disorder (ASD). The overall aim of the current study is to evaluate the effectiveness of an educational program on parenting stress and coping mechanism among parents of children with ASD in Jordan.
Methods: A cluster randomized controlled trial will be conducted in 4 private centers for the treatment of Autistic Disorder in Amman, Jordan. Inclusion criteria: father or mother of a child who diagnosed for the period of three years since the initial time of diagnosis, father or mother who provides care and living together with the child, father or mother has the ability to read and write Arabic, father or mother age above 20 years old,and center provides caring just for ASD child with age 12 years and younger. Exclusion criteria: father or mother whose child had other chronic or illnesses (e.g, type 1 diabetes, down syndrome, learning disabilities, fetal alcohol syndrome), foreign father or mother of a child with ASD residents in Amman, father or mother who previously participated in the intervention research (e.g, Cognitive Behavior Therapy, Mindfulness-Based Intervention), father or mother of a child who takes any pharmacologic management of ASD (e.g,Risperdal, Ritalin), father or mother with more than one child diagnosed with ASD,and center doesn't include a suitable classroom for implementing the intervention program. The educational intervention program will deliver to the intervention group as a one-day event in four sessions. Whereas, the control group will receive education about the communicable disease among childhood. With an estimated effect design of 1.3, a cluster size of 4 and 20% non-completion, the trial will need to enroll 200 participants. The primary outcomes of the current study are parenting stress and coping mechanism scores, which will be assessed using the Parent Stress Index-Short Form and Brief COPE, respectively. parenting stress and coping mechanism scores will be assessed at pre-intervention, post-intervention and follow-ups at week 8.
Results: The parenting stress and the coping mechanism will be compared between the intervention and control groups using A 2×3 repeated measure ANOVA.
Conclusions: Hypothesize that primary outcomes will improve significantly after the intervention compared to the control group. The finding from this study will determine the effectiveness of the educational program on parenting stress and coping mechanism among Jordanian parents of children with ASD. If proven to be effective, the educational program can serve as a part of therapeutic plan support to reduce parenting stress and improve coping mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expermental | Experimental | Other: Educational program on parenting stress and coping mechanismIn the intervention group, the educational program will deliver as a one-day event in four sessions: (1)background of autism spectrum disorder(ASD) and coping mechanism,(2) targeting communication and social difficulties among ASD children using coping mechanism,(3) targeting behavior problems among ASD children using coping mechanism, and (4) stress management as coping mechanism. |
| Control | Active comparator | Other: Educational program on parenting stress and coping mechanismIn the control group, the educational about communicable disease among childhood deliver as a one-day event in four sessions: (1) introduction and background communicable disease of childhood,(2) communicable diseases of childhood (Chicken Pox, Diphtheria,and pertussis[a whooping cough]),(3) communicable diseases of childhood (Measles,Mumps,rubella[German Measles]and Poliomyelitis(,and (4) infection control. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Father or mother of a child who diagnosed for the period of three years since the initial time of diagnosis
- Father or mother who provides care and living together with the child
- Father or mother has the ability to read and write Arabic, and (4) father or mother age above 20 years old
- Center provides caring only for ASD child with age 12 years and younger
- Provide the following services: speech, language, occupational, physiotherapy, educational, nutrition and medical services.
Key exclusion criteria (8 listed)
- The participant's exclusion eligibility criteria
- Father or mother whose child had other chronic or illnesses (e.g, type 1 diabetes, down syndrome, learning disabilities, fetal alcohol syndrome)
- Foreign father or mother of a child with ASD residents in Amman
- Father or mother who previously participated in the intervention research (e.g, Cognitive Behavior Therapy, Mindfulness-Based Intervention)
- Father or mother of a child who takes any pharmacologic management of ASD (e.g,Risperdal, Ritalin)
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 |
|---|---|---|
| Educational program on parenting stress and coping mechanismThe educational program will deliver as a one-day event in four sessions: (1)background of autism spectrum disorder(ASD) and coping mechanism,(2) targeting communication and social difficulties among ASD children using coping mechanism,(3) targeting behavior problems among ASD children using coping mechanism, and (4) stress management as coping mechanism. The contents of the educational program deliver through the use of PowerPoint slides, Whiteboard and marker, practical exercise, video clips followed by group discussion and provision a hard copy booklet containing all items which were supposed to discuss. As well as each session will approximately be taken one hour. Each group will consist of 10 participants. | Other | Control, Expermental |
Primary outcome
parenting stress
Time frame: Mean change in scores of parenting stress from baseline to endpoint(two months follow-up) assessment
Self reported 36 statements on three subscales: parental distress (PD), parent-child dysfunctional interaction (P-CDI), and difficulty of the child (DC). Each subscale contains 12 items. The PSI-SF rated on a 5-point Likert scale, include 1 (strongly disagree) , 2 ( disagree ), 3 ( not sure ), 4 (agree) 5 (strongly agree), total scores range from 36 to 180. On the PSI-SF, stress levels considered normal with less than 90 scores , whereas , high-stress considered at or above the 90 scores
coping mechanism
Time frame: Mean change in scores of coping mechanism from baseline to endpoint(two months follow-up) assessment
self-administered questionnaire twenty-eight items of the Brief COPE are grouped into fourteen subscales containing two items for each: acceptance, active coping, planning, behavioral disengagement, denial, substance use, humor, positive reframing, religious coping, self-blame, self-distraction, use of emotional support, use of instrumental support, and venting emotions . The items of subscale rated on a four-point Likert scale with a response for each item ranging from 1 ( I haven't been doing this at all ) to 4 (I have been doing this a lot)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: Yes. Primary outcomes measures will be made available
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational program on parenting stress and coping mechanism in people with Autism Spectrum Disorder, run by Universiti Putra Malaysia at 2 sites in Jordan.
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 7 inclusion and 8 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Jordan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haytham Al-Oran, PhD student (+962775740645, hyttiemaloran@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parenting stress (time frame: Mean change in scores of parenting stress from baseline to endpoint(two months follow-up) assessment). The study lists 2 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 16 Jan 2019.