Effectiveness of Parent-Mediated Intervention Combined With Positive Behavioral Support on Challenging Behaviors and Parenting Stress Among Children With Autism.
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Multiple Locations, Pakistan, 60000
- The Islamia University of Bahawalpur
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
Duration: 8-10 weeks intervention, 2 sessions per week (total 16-20 sessions)
Teaching: Replacement behaviors Reinforcement techniques Behavior management plans |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Aberrant Behavior Checklist (ABC)
Ramy czasowe: 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.
|
From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
|
|
Parenting Stress Index (PSI)
Ramy czasowe: 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.
|
From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Adaptive functioning (VABS)
Ramy czasowe: From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
|
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.
|
From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
|
|
Treatment Adherence
Ramy czasowe: From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
|
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.
|
From baseline (week 0), mid-intervention assessment (week 6), to post-intervention assessment at 12 weeks
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Khizra Iqbal, The Islamia University Bahawalpur, Punjab Pakistan
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ECSFLLSDU2025-10.
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Zaburzenia ze spektrum autyzmu
-
Chinese PLA General HospitalRekrutacyjnyNeuromyelitis Optica Spectrum Disorder AtakChiny
-
Jagannadha R AvasaralaZakończonyStwardnienie rozsiane | Zapalenie nerwu wzrokowego | Neuromyelitis Optica Spectrum Disorder Atak | Zapalenie nerwu wzrokowego i spektrum zaburzeń nerwu wzrokowego Nawrót | Neuromyelitis Optica Spectrum Disorder ProgresjaStany Zjednoczone
-
Tianjin Medical University General HospitalAktywny, nie rekrutującyNeuromyelitis Optica Spectrum Disorder AtakChiny
-
Tianjin Medical University General HospitalWycofaneNeuromyelitis Optica Spectrum Disorder Atak
-
Experimental and Clinical Research Center, a cooperation...RekrutacyjnyStwardnienie rozsiane | Choroby demielinizacyjne | Zapalenie nerwu wzrokowego | Neuromyelitis Optica Spectrum Disorder Atak | Choroba związana z przeciwciałami glikoproteinowymi mieliny oligodendrocytówWłochy, Stany Zjednoczone, Argentyna, Australia, Botswana, Brazylia, Kolumbia, Dania, Francja, Niemcy, Indie, Izrael, Japonia, Republika Korei, Hiszpania, Zjednoczone Królestwo, Zambia
-
Chinese PLA General HospitalJeszcze nie rekrutacjaNeuromyeeliitis Optica Spectrum Choroba (NMOSD)Chiny
-
Bjorn H. EbdrupVentriJect ApS; Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg...RekrutacyjnyZaburzenie afektywne dwubiegunowe | Ciężka choroba psychiczna | Schizofrenia Spectrum & amp; Inne zaburzenia psychotyczneDania
-
Fondazione Policlinico Universitario Agostino Gemelli...Aktywny, nie rekrutującySzczepionka | Uogólniona miastenia | System uzupełniający | Neuromyeeliitis Optica Spectrum Choroba (NMOSD)Włochy
-
Wuhan Union Hospital, ChinaNanjing Legend Biotech Co.RekrutacyjnyMyasthenia Gravis | Stwardnienie rozsiane (SM) | Neuromyeeliitis Optica Spectrum Choroba (NMOSD) | Zaburzenia związane z glikoproteiną oligodendrocytów anty-mieliną (MOGAD)Chiny
-
Psyrin Inc.Allwell Behavioral Health Services; The Brookline CenterRejestracja na zaproszenieZespół nadpobudliwości psychoruchowej z deficytem uwagi (ADHD) | Zaburzenia ze spektrum autyzmu | Zespołu stresu pourazowego | Zaburzenie obsesyjno-kompulsyjne (OCD) | Choroba afektywna dwubiegunowa (ChAD) | Depresja - duże zaburzenie depresyjne | Lęk, uogólniony | Schizofrenia Spectrum & amp; Inne zaburzenia...Stany Zjednoczone