Clinical trial NCT04339153: Feasibility Study on Parents Skill Training Program for Reducing Parental Distress and Disruptive Behavior of Their Children With Autism Spectrum Disorder (ASD)
Official title: Feasibility Study on Parents Skill Training Program for Reducing Parental Distress and Disruptive Behavior of Their Children With Autism Spectrum Disorder (ASD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Disruptive Behaviours
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Aberrant Behavior Checklist-Community (ABC-C; Aman & Singh, 1994)
timeFrame: 24 weeks
measure: Parenting Stress Index, Fourth Edition Short Form (PSI-4; Abidin, 1995)
timeFrame: 24 weeks
measure: Symptom Checklist-90 (SCL-90, Derogatis, Rickels, Rock, 1976)
timeFrame: 24 weeks
Secondary outcomes:
measure: Vineland Adaptive Behavior Scales (Vineland-II; Sparrow, Cicchetti, & Balla, 2005)
timeFrame: 24 weeks
measure: Home Situations Questionnaire Disorder (HSQ; Chowdhury et al, 2016)
timeFrame: 24 weeks
measure: Clinical Global Impressions - Improvement Scale (CGI; Guy 1976)
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: FUI
name: Nadia Shafique, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: FUI
name: Nasim Chaudhary, Dr. Prof.
role: STUDY_CHAIR
affiliation: University of Manchester
name: Nusrat Hussain, Dr. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Greenwich University
name: Jumana Ahmad
role: PRINCIPAL_INVESTIGATOR
References: