Feasibility Study on Parents Skill Training Program for Reducing Parental Distress and Disruptive Behavior of Their Children With Autism Spectrum Disorder (ASD)

Autism Spectrum Disorder Clinical Trial

Official title:

Feasibility Study on Parents Skill Training Program for Reducing Parental Distress and Disruptive Behavior of Their Children With Autism Spectrum Disorder (ASD)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04339153
• Other study ID #: FUI/CTR/2020/2
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2, 2020
• Est. completion date: September 2, 2021

Study information

• Verified date: April 2020
• Source: Foundation University Islamabad
• Contact: Nadia Shafique, PhD
• Phone: 03335513401
• Email: nadiashafique17[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2, 2021
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disruptive Behaviours
• Problem Behavior

Intervention

Behavioral:
• Parent Training for Disruptive Behaviours
Critically, PT also involves education about autism during the initial sessions, and thus benefits of PT are inferred to come from the specific training.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Foundation University Islamabad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	24 weeks
Primary	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.	24 weeks
Primary	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.	24 weeks
Secondary	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.	24 weeks
Secondary	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.	24 weeks
Secondary	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.	24 weeks