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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03805828
Other study ID # University Putra Malaysia
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date August 1, 2019

Study information

Verified date January 2019
Source Universiti Putra Malaysia
Contact Haytham Al-Oran, PhD student
Phone +962775740645
Email hyttiemaloran@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 1, 2019
Est. primary completion date August 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Educational program on parenting stress and coping mechanism
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.

Locations

Country Name City State
Jordan Centers for the treatment of Autistic Disorder Amman
Jordan Ministry of Social Development Amman

Sponsors (1)

Lead Sponsor Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Jordan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mean change in scores of parenting stress from baseline to endpoint(two months follow-up) assessment
Primary 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) Mean change in scores of coping mechanism from baseline to endpoint(two months follow-up) assessment
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