- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07570550
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Multiple Locations, Paquistão, 60000
- The islamia university of Bahawalpur
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Aberrant Behavior Checklist (ABC)
Prazo: 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)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adaptive functioning (VABS)
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Khizra Iqbal, The Islamia University Bahawalpur, Punjab Pakistan
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ECSFLLSDU2025-10.
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .