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Effectiveness of Educational Program on Parenting Stress and Coping Mechanism Among Parents of Children With Autism Spectrum Disorder in Amman, Jordan

Primary Purpose

Autism Spectrum Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Educational program on parenting stress and coping mechanism
Sponsored by
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism spectrum disorder, parenting stress, coping mechanism, coping strategies, education program, educational intervention

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

  • Centers for the treatment of Autistic Disorder
  • Ministry of Social DevelopmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Expermental

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

Full Information

First Posted
January 8, 2019
Last Updated
January 12, 2019
Sponsor
Universiti Putra Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT03805828
Brief Title
Effectiveness of Educational Program on Parenting Stress and Coping Mechanism Among Parents of Children With Autism Spectrum Disorder in Amman, Jordan
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Putra Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism spectrum disorder, parenting stress, coping mechanism, coping strategies, education program, educational intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Expermental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Educational program on parenting stress and coping mechanism
Intervention Description
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.
Primary Outcome Measure Information:
Title
parenting stress
Description
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
Time Frame
Mean change in scores of parenting stress from baseline to endpoint(two months follow-up) assessment
Title
coping mechanism
Description
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)
Time Frame
Mean change in scores of coping mechanism from baseline to endpoint(two months follow-up) assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haytham Al-Oran, PhD student
Phone
+962775740645
Email
hyttiemaloran@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Khuan, Dr.
Phone
603 - 8947 2438
Email
leekhuan@upm.edu.my
Facility Information:
Facility Name
Centers for the treatment of Autistic Disorder
City
Amman
Country
Jordan
Individual Site Status
Not yet recruiting
Facility Name
Ministry of Social Development
City
Amman
Country
Jordan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Primary outcomes measures will be made available
IPD Sharing Time Frame
Data will be available within 7 months
IPD Sharing Access Criteria
Date request will be reviewed by an external independent review panel. Requesters will be required to sign the data access agreement

Learn more about this trial

Effectiveness of Educational Program on Parenting Stress and Coping Mechanism Among Parents of Children With Autism Spectrum Disorder in Amman, Jordan

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