A Three-Arm Cluster-Randomized Comparative Effectiveness Trial of Professional-Led and Peer-Led Pepea Pamoja for Caregivers of Children With Autism in Western Kenya
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Family Burden and Stress
研究概览
简要总结
Pepea Pamoja is a ten-session, group-based caregiver intervention designed to improve caregiver well-being and strengthen caregivers' ability to support communication and positive behavior in children with autism. This study will enroll approximately 240 caregivers of children ages 2-8 years in western Kenya. Caregiver groups will be randomized to one of three conditions: standard-of-care control, professional-led Pepea Pamoja, or peer-led Pepea Pamoja.
The study will determine whether each Pepea Pamoja delivery model improves caregiver and child outcomes compared with control and will directly compare peer-led and professional-led delivery. Outcomes will include caregiver stress and well-being, child communication and behavior, and blinded observations of child social communication and caregiver-child interaction. An embedded mixed-methods evaluation will examine implementation, sustainability, program and societal costs, and cost-effectiveness.
详细描述
Autism spectrum disorder is a common neurodevelopmental condition associated with challenges in communication, social interaction, behavior, adaptive functioning, and family well-being. Access to autism-specific intervention remains limited in many low-resource settings, including Kenya, where shortages of trained specialists and services create substantial barriers to care. Caregiver-mediated interventions offer an important opportunity to improve outcomes by strengthening caregivers' ability to support their children's communication, behavior, and development during everyday routines while also addressing caregiver well-being.
Pepea Pamoja ("to lift or float together" in Kiswahili) is a culturally responsive, group-based caregiver intervention developed to improve caregiver well-being and increase caregivers' skills in supporting communication and positive behavior among children with autism. The ten-session program integrates autism education, caregiver coping and self-care, communication and behavior-support strategies, visual supports, positive reinforcement, guided problem solving, caregiver-child practice activities, and peer support. The intervention is designed to strengthen caregiver knowledge, self-efficacy, coping skills, and use of evidence-informed communication and behavior-support strategies during daily interactions with their children. These changes are hypothesized to improve caregiver-child interactions, child communication and behavior, caregiver stress, and family quality of life.
This study is a three-arm cluster-randomized comparative effectiveness trial conducted in western Kenya. Approximately 240 caregiver-child dyads will be enrolled in 48 caregiver groups (clusters) and randomized in a 1:1:1 ratio to one of three study conditions: (1) standard-of-care control, (2) professional-led Pepea Pamoja, or (3) peer-led Pepea Pamoja. Randomization will occur at the caregiver group level to minimize contamination and reflect the group-based nature of intervention delivery. Consecutively formed caregiver clusters will be randomized at prespecified allocation waves, with equal numbers of clusters assigned to each study arm during each wave of enrollment.
The first aim is to determine the effectiveness of professional-led and peer-led Pepea Pamoja compared with standard-of-care control on caregiver and child outcomes. Outcomes include caregiver burden and well-being, child communication, child behavior, child quality of life, and caregiver-child interaction. Assessments will be conducted at baseline, immediately following intervention completion, and approximately three months after intervention completion.
The second aim is to compare peer-led and professional-led delivery models and evaluate potential mechanisms through which facilitator type may influence outcomes. These mechanisms include caregiver knowledge, self-efficacy, caregiver strategy use, and caregiver-child interaction. The study will evaluate whether differences in facilitator type are associated with differences in caregiver or child outcomes and will estimate comparative effectiveness between the two active intervention models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and facilitators cannot be masked because of the nature of the behavioral intervention. Independent outcome assessors will remain masked to assigned study arm whenever feasible. Coders of standardized caregiver-child interaction recordings will be masked to study arm and assessment time point.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregiver age ≥18 years
- •Able to provide informed consent
- •English or Kiswahili speaking
- •Primary caregiver and legal guardian
- •Provides ≥20 hours/week caregiving
- •Resides within MTRH catchment area
- •Intends to attend study activities
- •Child 2-8 years of age
- •Child has autism diagnosis or meets study eligibility criteria for suspected autism
排除标准
- •Caregiver lacks capacity to provide informed consent.
- •Child has a vision or hearing impairment that would preclude valid participation in the intervention or outcome assessments.
- •Child is currently receiving another structured autism intervention at enrollment.
研究组 & 干预措施
Professional-led Pepea Pamoja
Participants will receive the standardized ten-session Pepea Pamoja caregiver intervention delivered by trained professional facilitators, including professionals with backgrounds such as occupational therapy, psychology, speech-language therapy, special education, or related disciplines. The curriculum includes autism education, caregiver coping and self-care, communication and behavior-support strategies, visual supports, positive reinforcement, requesting skills, guided problem solving, caregiver-child practice activities, and group-based peer support.
干预措施: Professionally-facilitated groups (Behavioral)
Peer-led Pepea Pamoja
Participants will receive the same ten-session Pepea Pamoja curriculum, dose, caregiver practice opportunities, participant materials, and fidelity standards delivered by trained and competency-certified caregivers with lived experience caring for a child with autism. Peer facilitators will receive structured supervision, fidelity monitoring, booster training, and remediation when indicated
干预措施: Peer-facilitated groups (Behavioral)
Standard of Care Control
Participants will receive information about locally available services, including occupational therapy at MTRH, private speech-language therapy options, and relevant schools and community resources. Participants may receive any otherwise available non-study care, which will be documented. They will also be invited to a moderated caregiver group chat that supports social connection but does not provide Pepea Pamoja curriculum content, caregiver skills instruction, or intervention coaching.
结局指标
主要结局
Family Burden and Stress
时间窗: Baseline, post-intervention, and 3-month follow-up
Change in caregiver-reported burden and stress levels from baseline to 3 months, measured using the Caregiver Self-Assessment Questionnaire developed by the American Medical Association. This 18-item tool includes 16 yes/no items assessing emotional and physical strain, one item rating stress on a scale from 1 (no stress) to 10 (high stress), and one item comparing current health to health one year ago. Higher scores indicate greater caregiver burden and stress.
Child Functional Communication
时间窗: Baseline, immediately post-intervention, and 3-month follow-up
Change in child functional communication measured using the Communication and Symbolic Behavior Scales (CSBS). Higher scores indicate stronger communication skills and improved functional communication abilities.
Family Burden and Stress
时间窗: Baseline and 3 months
Change in caregiver-reported burden and stress levels from baseline to 3 months, measured using the Caregiver Self-Assessment Questionnaire developed by the American Medical Association. This 18-item tool includes 16 yes/no items assessing emotional and physical strain, one item rating stress on a scale from 1 (no stress) to 10 (high stress), and one item comparing current health to health one year ago. Higher scores indicate greater caregiver burden and stress.
Autism Impact Measure (AIM)
时间窗: Baseline and 3 months
Change in caregiver-reported communication and symbolic behavior from baseline to 3 months, measured using the Autism Impact Measure (AIM), which integrates domains from the Communication and Symbolic Behavior Scale (CSBS). The AIM is a validated caregiver-report tool assessing autism-related behaviors across five domains, including communication and social reciprocity. The CSBS is a norm-referenced, standardized instrument that evaluates early communication development through 22 rating scales grouped into seven clusters: communicative functions, gestural and vocal means, verbal means, reciprocity, social-affective signaling, and symbolic behavior. Higher AIM scores indicate greater autism-related impact.
次要结局
- Quality of Life in Caregivers(Baseline, post-intervention, and 3-month follow-up)
- Quality of Life in Children(Baseline, post-intervention, and 3-month follow-up)
- Parenting Stress Index(Baseline, post-intervention, and 3-month follow-up)
- Depressive Symptoms in Caregivers(Baseline, post-intervention, and 3-month follow-up)
- Child Behavior Checklist (CBCL)(Baseline, post-intervention, and 3-month follow-up)
- Observed Child Social Communication(Baseline, post-intervention, and 3-month follow-up)
- Observed Caregiver-Child Interaction Quality(Baseline, post-intervention, and 3-month follow-up)
- Observed Caregiver Strategy Use(Baseline, post-intervention, and 3-month follow-up)
- Autism-Related Functioning(Baseline, post-intervention, and 3-month follow-up.)
- Quality of Life in Caregivers(Baseline and 3 months)
- Quality of Life in Children(Baseline and 3 months)
- Parenting Stress Index(Baseline and 3 months)
- Depressive Symptoms in Caregivers(Baseline and 3 months)
- Child Behavior Checklist (CBCL)(Baseline and 3 months)
- Delivery Method Comparison: Peer-led vs Professional-led Intervention(3 months)
- Incremental Cost-Effectiveness Ratio (ICER)(3 months)
研究者
Megan Song McHenry
Associate Professor
Indiana University