Autism Spectrum DisorderNCT07570550
Effectiveness of Parent-Mediated Intervention Combined With Positive Behavioral Support on Challenging Behaviors and Parenting Stress Among Children With Autism.
A study testing Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS) in people with Autism Spectrum Disorder, run by Islamia University of Bahawalpur at 1 site in Pakistan.
Trial summary
This study aims to evaluate the effectiveness of a parent-mediated intervention combined with Positive Behavioral Support (PBS) in reducing challenging behaviors among children with autism and decreasing parenting stress in South Punjab, Pakistan. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria: Children aged 3 to 12 years with a confirmed diagnosis of ASD (based on DSM-5 criteria).
Presence of at least two moderate-to-severe "challenging behaviors" as reported by parents.
Parents/caregivers who are the primary providers of daily care. Residents of South Punjab for the past 12 months.
Exclusion Criteria: Children with severe comorbid physical disabilities (e.g., total blindness or deafness) that prevent participation in standard PBS activities.
Parents currently enrolled in other intensive behavioral training programs.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The Islamia University of Bahawalpur
Multiple Locations, 60000
About this study
Official title: Effectiveness of Parent-Mediated Intervention Combined With Positive Behavioral Support on Challenging Behaviors and Parenting Stress Among Children With Autism in South Punjab: A Quasi-Experimental Study
This study aims to evaluate the effectiveness of a parent-mediated intervention combined with Positive Behavioral Support (PBS) in reducing challenging behaviors among children with autism and decreasing parenting stress in South Punjab, Pakistan. By equipping parents with PBS techniques, the intervention seeks to identify and manage behavioral triggers, thereby improving child behavior and reducing caregiver strain.
There is a growing need for culturally adapted intervention programs in local languages such as Urdu and Seraiki, tailored to the socio-cultural context of Pakistani families. This study addresses this gap by providing indigenous evidence on a dual-component intervention (Parent-Mediated Intervention + PBS) designed specifically for the family structure and caregiving practices in South Punjab.
Read the detailed description
This quasi-experimental study is designed to examine the effectiveness of a combined Parent-Mediated Intervention (PMI) and Positive Behavioral Support (PBS) program in managing challenging behaviors among children diagnosed with autism spectrum disorder and reducing parenting stress among their caregivers in South Punjab, Pakistan.
Children with autism often exhibit challenging behaviors such as aggression, self-injury, and non-compliance, which significantly increase caregiver burden and negatively impact family functioning. In low-resource settings like South Punjab, access to structured behavioral interventions is limited, and most available programs are not culturally or linguistically adapted.
The intervention program in this study integrates parent training (PMI) with evidence-based behavioral strategies (PBS). Parents will be trained to identify antecedents and consequences of challenging behaviors, implement behavior modification techniques, and reinforce adaptive behaviors in natural home settings. The intervention will be delivered in local languages (Urdu and Seraiki) to enhance accessibility and comprehension.
Participants will be divided into intervention and control groups. The intervention group will receive the combined PMI + PBS program, while the control group will receive treatment as usual. Standardized measures will be used to assess changes in child behavior and parenting stress before and after the intervention.
The findings of this study are expected to provide culturally relevant evidence for scalable, family-based interventions in Pakistan and contribute to improving the quality of life of children with autism and their caregivers.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS)
- 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.
Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS)Behavioural
Duration: 8-10 weeks intervention, 2 sessions per week (total 16-20 sessions)
- Parent-Mediated Intervention (PMI) included Training parents in: Communication strategies Positive reinforcement Managing child behavior
- Positive Behavioral Support (PBS) Functional behavior assessment Identifying triggers of behavior
Teaching:
Replacement behaviors Reinforcement techniques Behavior management plans
| Study group | Role | What they receive |
|---|---|---|
| Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS) | Experimental | Participants in this arm will receive a structured parent-mediated intervention combined with Positive Behavioral Support (PBS). Parents will be trained to identify antecedents and consequences of challenging behaviors, implement behavior modification strategies, and reinforce adaptive behaviors in their children.
The intervention will be delivered through weekly structured sessions over a period of 12 weeks. Each session will include psychoeducation, skills training, modeling, and guided practice. Parents will also be assigned home-based tasks to apply learned strategies in natural settings. The intervention will be delivered in local languages (Urdu and Seraiki) to ensure cultural relevance and comprehension. Receives: Behavioral: Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist (ABC)
The Aberrant Behavior Checklist (ABC) is a standardized caregiver-reported scale used to assess problem behaviors in children with developmental disorders. It includes 58 items across five domains: irritability, lethargy/social withdrawal, stereotypic behavior, hyperactivity, and inappropriate speech. Each item is rated on a 4-point scale (0-3), with total scores ranging from 0 to 174. Higher scores indicate greater severity of challenging behaviors, reflecting a worse outcome.
Measured: From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
Parenting Stress Index (PSI)
The Parenting Stress Index (PSI) is a standardized self-report measure assessing stress experienced by parents in relation to child-rearing. It includes domains such as parental distress, parent-child dysfunctional interaction, and difficult child characteristics. Scores typically range from 36 to 180 (short form). Higher scores indicate greater parenting stress, reflecting a worse outcome.
Measured: From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
Secondary outcomes (2)
Adaptive functioning (VABS)
The Vineland Adaptive Behavior Scales (VABS) is a standardized instrument used to assess adaptive functioning, including communication, daily living skills, socialization, and motor skills. Scores are reported as standard scores with a mean of 100 and a standard deviation of 15, typically ranging from approximately 20 to 160. Higher scores indicate better adaptive functioning, reflecting a better outcome.
Measured: From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
Treatment Adherence
Treatment adherence will be measured as the percentage of intervention sessions attended by parents out of the total number of scheduled sessions. Adherence will be calculated as a percentage ranging from 0% to 100%. Higher percentages indicate greater adherence to the intervention protocol, reflecting a better outcome.
Measured: From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jan 2026
- Primary completion1 May 2026 (estimated)
- Study completionJul 2026 (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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Islamia University of Bahawalpur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khizra Iqbal, The Islamia University of Bahawalpur, Khawaja Fareed CampusDr
- Investigators
- Khizra Iqbal, Principal investigator, The Islamia University Bahawalpur, Punjab Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570550
- Sponsor's protocol ID
- ECSFLLSDU2025-10.
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Parent-Mediated Intervention Combined With Positive Behavioral Support on Challenging Behaviors and Parenting Stress Among Children With Autism in South Punjab: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07570550
- Acronym / sponsor ID
- ECSFLLSDU2025-10.
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Islamia University of BahawalpurUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 6 May 2026 (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.
This study aims to evaluate the effectiveness of a parent-mediated intervention combined with Positive Behavioral Support (PBS) in reducing challenging behaviors among children with autism and decreasing parenting stress in South Punjab, Pakistan. By equipping parents with PBS techniques, the intervention seeks to identify and manage behavioral triggers, thereby improving child behavior and reducing caregiver strain.
There is a growing need for culturally adapted intervention programs in local languages such as Urdu and Seraiki, tailored to the socio-cultural context of Pakistani families. This study addresses this gap by providing indigenous evidence on a dual-component intervention (Parent-Mediated Intervention + PBS) designed specifically for the family structure and caregiving practices in South Punjab.
Detailed description
This quasi-experimental study is designed to examine the effectiveness of a combined Parent-Mediated Intervention (PMI) and Positive Behavioral Support (PBS) program in managing challenging behaviors among children diagnosed with autism spectrum disorder and reducing parenting stress among their caregivers in South Punjab, Pakistan.
Children with autism often exhibit challenging behaviors such as aggression, self-injury, and non-compliance, which significantly increase caregiver burden and negatively impact family functioning. In low-resource settings like South Punjab, access to structured behavioral interventions is limited, and most available programs are not culturally or linguistically adapted.
The intervention program in this study integrates parent training (PMI) with evidence-based behavioral strategies (PBS). Parents will be trained to identify antecedents and consequences of challenging behaviors, implement behavior modification techniques, and reinforce adaptive behaviors in natural home settings. The intervention will be delivered in local languages (Urdu and Seraiki) to enhance accessibility and comprehension.
Participants will be divided into intervention and control groups. The intervention group will receive the combined PMI + PBS program, while the control group will receive treatment as usual. Standardized measures will be used to assess changes in child behavior and parenting stress before and after the intervention.
The findings of this study are expected to provide culturally relevant evidence for scalable, family-based interventions in Pakistan and contribute to improving the quality of life of children with autism and their caregivers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS) | Experimental | Behavioral: Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS)Participants in this arm will receive a structured parent-mediated intervention combined with Positive Behavioral Support (PBS). Parents will be trained to identify antecedents and consequences of challenging behaviors, implement behavior modification strategies, and reinforce adaptive behaviors in their children. The intervention will be delivered through weekly structured sessions over a period of 12 weeks. Each session will include psychoeducation, skills training, modeling, and guided practice. Parents will also be assigned home-based tasks to apply learned strategies in natural settings. The intervention will be delivered in local languages (Urdu and Seraiki) to ensure cultural relevance and comprehension. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS)Duration: 8-10 weeks intervention, 2 sessions per week (total 16-20 sessions) 1. Parent-Mediated Intervention (PMI) included Training parents in: Communication strategies Positive reinforcement Managing child behavior 2. Positive Behavioral Support (PBS) Functional behavior assessment Identifying triggers of behavior Teaching: Replacement behaviors Reinforcement techniques Behavior management plans | Behavioural | Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS) |
Primary outcome
Aberrant Behavior Checklist (ABC)
Time frame: From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
The Aberrant Behavior Checklist (ABC) is a standardized caregiver-reported scale used to assess problem behaviors in children with developmental disorders. It includes 58 items across five domains: irritability, lethargy/social withdrawal, stereotypic behavior, hyperactivity, and inappropriate speech. Each item is rated on a 4-point scale (0-3), with total scores ranging from 0 to 174. Higher scores indicate greater severity of challenging behaviors, reflecting a worse outcome.
Parenting Stress Index (PSI)
Time frame: From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
The Parenting Stress Index (PSI) is a standardized self-report measure assessing stress experienced by parents in relation to child-rearing. It includes domains such as parental distress, parent-child dysfunctional interaction, and difficult child characteristics. Scores typically range from 36 to 180 (short form). Higher scores indicate greater parenting stress, reflecting a worse outcome.
2 secondary outcomes
Adaptive functioning (VABS)
Time frame: From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
Treatment Adherence
Time frame: From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
Khizra Iqbal principal investigator
The Islamia University Bahawalpur, Punjab Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Mediated Intervention + Positive Behavioral Support (PMI + PBS) in people with Autism Spectrum Disorder, run by Islamia University of Bahawalpur at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant Behavior Checklist (ABC) (time frame: From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks). 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 6 May 2026.