Autism Spectrum DisorderNCT07259044
Pepea Pamoja: Cluster-Randomized Trial for Caregivers of Children With Autism in Kenya
A study testing Professionally-facilitated groups and Peer-facilitated groups in people with Autism Spectrum Disorder and Autism, run by Indiana University at 1 site in Kenya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism, ASD
- What is being tested?
- Professionally-facilitated groups and Peer-facilitated groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteKenya
- Study dates
- 1 Jul 2027to 1 Jun 2030
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Intends to attend study activities
- Child 2-8 years of age
- Child has autism diagnosis or meets study eligibility criteria for suspected autism
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
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.
The third aim is to compare implementation, sustainability, and economic outcomes associated with professional-led and peer-led delivery of Pepea Pamoja. The study will assess implementation outcomes including acceptability, appropriateness, feasibility, fidelity, reach, adaptations, facilitator competency, facilitator burden, facilitator retention, and supervision requirements. Sustainability outcomes will evaluate the resources, organizational supports, and workforce requirements needed to maintain intervention delivery beyond the study period. Economic analyses will compare program costs, societal costs, and cost-effectiveness across study arms.
The results of this study will provide evidence regarding the effectiveness of Pepea Pamoja, the comparative effectiveness of professional-led and peer-led delivery models, and the implementation, sustainability, and economic requirements needed to support adoption and scale-up of caregiver-mediated autism interventions in resource-constrained settings.
- Conditions
- Autism Spectrum Disorder, Autism, ASD
- Being tested
- Professionally-facilitated groups, Peer-facilitated groups
- Keywords
- Caregiver Intervention, Training, Children, Low Resource, Disability, Early Intervention
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Professionally-facilitated groupsBehavioural
Participants will receive the standardized ten-session Pepea Pamoja caregiver intervention delivered by trained professional facilitators. Core curriculum content, session structure, caregiver practice opportunities, participant materials, and fidelity standards will be standardized across active intervention arms.
Peer-facilitated groupsBehavioural
Participants will receive the same Pepea Pamoja curriculum and intervention dose as the professional-led arm. Delivery will be provided by trained caregivers with lived experience raising a child with autism who have successfully completed facilitator training and competency assessment.
| Study group | Role | What they receive |
|---|---|---|
| Professional-led Pepea Pamoja | Experimental | 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. Receives: Behavioral: Professionally-facilitated groups |
| Peer-led Pepea Pamoja | Experimental | 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 Receives: Behavioral: Peer-facilitated groups |
| Standard of Care Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Burden and Stress
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.
Measured: Baseline, post-intervention, and 3-month follow-up
Child Functional Communication
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.
Measured: Baseline, immediately post-intervention, and 3-month follow-up
Secondary outcomes (10)
Quality of Life in Caregivers
Change in caregiver-reported quality of life from baseline to 3 month follow-up, measured using the Quality of Life - Family Version instrument developed by Betty Ferrell, PhD. This 37-item ordinal scale assesses quality of life across four domains for family members caring for a patient. Each item is rated from 0 (worst outcome) to 10 (best outcome), with several items reverse-scored. Subscale scores are calculated by averaging items within each domain. Higher overall scores indicate better caregiver quality of life.
Measured: Baseline, post-intervention, and 3-month follow-up
Quality of Life in Children
Change in caregiver-reported quality of life for children from baseline to 3 month follow-up, measured using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales. This 23-item instrument assesses physical, emotional, social, and school functioning across four multidimensional scales and three summary scores. It is developmentally appropriate for ages 2-18 and includes both child self-report (ages 5-18) and parent proxy-report (ages 2-18). Scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline, post-intervention, and 3-month follow-up
Parenting Stress Index
Change in parenting stress from baseline to 3 month follow-up, measured using the Parenting Stress Index-Short Form (PSI-SF). The PSI-SF total score ranges from 36 to 180, with higher scores indicating greater parenting stress and a worse outcome. Each of the 36 items is rated on a 5-point Likert scale, and the measure includes three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child.
Measured: Baseline, post-intervention, and 3-month follow-up
Depressive Symptoms in Caregivers
Change in caregiver depressive symptoms from baseline to 3 month follow-up, measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 score ranges from 0 to 27, with higher scores indicating more severe depression and a worse outcome. Each item is scored from 0 (not at all) to 3 (nearly every day).
Measured: Baseline, post-intervention, and 3-month follow-up
Child Behavior Checklist (CBCL)
Change in child behavior scores from baseline to 3 month follow-up, as reported by caregivers using the Child Behavior Checklist (CBCL). The CBCL is part of the Achenbach System of Empirically Based Assessment and evaluates behavioral and emotional problems in children. Caregivers rate behaviors on a 3-point scale: 0 ("Not True"), 1 ("Somewhat or Sometimes True"), and 2 ("Very True or Often True"). Raw scores are converted to T-scores ranging from 0 to 100. Higher T-scores indicate greater behavioral or emotional problems and a worse outcome.
Measured: Baseline, post-intervention, and 3-month follow-up
Observed Child Social Communication
Change in child social communication measured using the Brief Observation of Social Communication Change (BOSCC) during standardized caregiver-child interaction activities coded by raters blinded to intervention arm and assessment time point.
Measured: Baseline, post-intervention, and 3-month follow-up
Incremental Cost-Effectiveness Ratio (ICER)
Effectiveness and cost will be analyzed jointly using multilevel models with random effects for site and group, and incremental cost-effectiveness ratios (ICERs) will be computed. Net Monetary Benefit (NMB) mixed-effect regressions will allow formal testing of heterogeneity (e.g., baseline severity of autism, living condition, caregiver education and other socioeconomic factors). Uncertainty will be assessed using clustered bootstraps and cost-effectiveness acceptability curves (CEACs).
Measured: 3 months
Observed Caregiver-Child Interaction Quality
Change in caregiver-child interaction quality assessed through structured observational coding of caregiver-child interaction activities using coding procedures informed by Joint Engagement Rating Inventory (JERI) constructs.
Measured: Baseline, post-intervention, and 3-month follow-up
Observed Caregiver Strategy Use
Change in caregiver use of communication and behavior-support strategies taught through the Pepea Pamoja intervention during standardized caregiver-child interaction activities.
Measured: Baseline, post-intervention, and 3-month follow-up
Autism-Related Functioning
Change in autism-related functioning measured using the Autism Impact Measure (AIM). The AIM is a caregiver-reported outcome measure designed to assess autism symptom impact and sensitivity to change over time. Higher scores indicate greater autism-related impact.
Measured: Baseline, post-intervention, and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Jul 2027 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Caregiver groups (clusters) will be randomized in a 1:1:1 ratio to standard-of-care control, professional-led Pepea Pamoja, or peer-led Pepea Pamoja. Consecutively formed caregiver groups will be randomized at prespecified allocation waves, with equal numbers of groups assigned to each study arm during each wave. Randomization occurs at the caregiver-group level to minimize contamination and reflect the group-based nature of intervention delivery.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Moi University
- Responsible party
- Principal investigator, Megan Song McHenry, Indiana University
- Investigators
- Eren Oyungu, MBChB, Principal investigator, Moi UniversityMegan S. McHenry, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259044
- Sponsor's protocol ID
- 96463446
- Status last verified
- Aug 2026
- First submitted
- 24 Sep 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McLay L, Emerson LM, Waddington H, van Deurs J, Hunter J, Blampied N, Hapuku A, Macfarlane S, Bowden N, van Noorden L, Rispoli M. Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial. BMJ Open. 2023 May 30;13(5):e071235. doi: 10.1136/bmjopen-2022-071235.
PubMed 37253492McNally Keehn R, Rispoli M, Saina C, Nafiseh A, Oyungu E, Omari FW, Kigen B, Hassinger T, Stewart L, Gross J, McHenry M. Pepea Pamoja:dagger Applying the Ecological Validity Framework to co-develop a wellbeing and behavioural training program for caregivers of young children with autism in low-resource settings of Kenya and the United States. Child Care Health Dev. 2024 Jul;50(4):e13299. doi: 10.1111/cch.13299.
PubMed 38967420Varni JW. PedsQL™ (Pediatric Quality of Life Inventory™). James W. Varni, Ph.D. Accessed September 18, 2025, https://www.pedsql.org
Ferrell BRaG, Marcia. Quality of Life - Family Version. City of Hope National Medical Center and Beckman Research Institute. Accessed September 18, 2025, https://www.cityofhope.org/sites/www/files/2022-06/1431763601545-qol-family%20%282%29.pdf
American Psychological Association. Caregiver Self-Assessment Questionnaire. American Psychological Association. Accessed September 18, 2025, https://www.apa.org/pi/about/publications/caregivers/practice-settings/assessment/tools/self-assessment
Mwangi P, Nyongesa MK, Koot HM, Cuijpers P, Newton CRJC, Abubakar A. Validation of a Swahili version of the 9-item Patient Health Questionnaire (PHQ-9) among adults living with HIV compared to a community sample from Kilifi, Kenya. J Affect Disord Rep. 2020 Dec;1:100013. doi: 10.1016/j.jadr.2020.100013.
PubMed 33313580Wetherby AMaP, Barry M. CSBS™ - Communication and Symbolic Behavior Scales. Brookes Publishing Co. Accessed September 18, 2025, https://brookespublishing.com/product/csbs
Rutter MB, Anthony; & Lord, Catherine. Social Communication Questionnaire (SCQ®). Western Psychological Services (WPS). Accessed September 18, 2025, https://www.wpspublish.com/scq-social-communication-questionnaire.html
Achenbach TM. Child Behavior Checklist for Ages 6-18 (CBCL/6-18). ASEBA, University of Vermont. Accessed September 18, 2025, https://aseba.org/wp-content/uploads/2019/02/schoolagecbcl.pdf
Mazurek MO, Carlson C, Baker-Ericzen M, Butter E, Norris M, Barr C, Kanne S. The Autism Impact Measure (AIM): Examination of Sensitivity to Change. Autism Res. 2020 Nov;13(11):1867-1879. doi: 10.1002/aur.2397. Epub 2020 Oct 1.
PubMed 33001561
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07259044
- Acronym / sponsor ID
- 96463446
- Conditions
- Autism Spectrum Disorder, Autism, ASD
- Keywords
- Caregiver Intervention, Training, Children, Low Resource, Disability, Early Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Moi University
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 2 Dec 2025 (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.
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.
Detailed description
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.
The third aim is to compare implementation, sustainability, and economic outcomes associated with professional-led and peer-led delivery of Pepea Pamoja. The study will assess implementation outcomes including acceptability, appropriateness, feasibility, fidelity, reach, adaptations, facilitator competency, facilitator burden, facilitator retention, and supervision requirements. Sustainability outcomes will evaluate the resources, organizational supports, and workforce requirements needed to maintain intervention delivery beyond the study period. Economic analyses will compare program costs, societal costs, and cost-effectiveness across study arms.
The results of this study will provide evidence regarding the effectiveness of Pepea Pamoja, the comparative effectiveness of professional-led and peer-led delivery models, and the implementation, sustainability, and economic requirements needed to support adoption and scale-up of caregiver-mediated autism interventions in resource-constrained settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Caregiver groups (clusters) will be randomized in a 1:1:1 ratio to standard-of-care control, professional-led Pepea Pamoja, or peer-led Pepea Pamoja. Consecutively formed caregiver groups will be randomized at prespecified allocation waves, with equal numbers of groups assigned to each study arm during each wave. Randomization occurs at the caregiver-group level to minimize contamination and reflect the group-based nature of intervention delivery.
| Arm | Type | Receives |
|---|---|---|
| Professional-led Pepea Pamoja | Experimental | Behavioral: Professionally-facilitated groupsParticipants 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. |
| Peer-led Pepea Pamoja | Experimental | Behavioral: Peer-facilitated groupsParticipants 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 |
| Standard of Care Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Caregiver age ≥18 years
- Able to provide informed consent
- English or Kiswahili speaking
- Primary caregiver and legal guardian
- Provides ≥20 hours/week caregiving
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Professionally-facilitated groupsParticipants will receive the standardized ten-session Pepea Pamoja caregiver intervention delivered by trained professional facilitators. Core curriculum content, session structure, caregiver practice opportunities, participant materials, and fidelity standards will be standardized across active intervention arms. | Behavioural | Professional-led Pepea Pamoja |
| Peer-facilitated groupsParticipants will receive the same Pepea Pamoja curriculum and intervention dose as the professional-led arm. Delivery will be provided by trained caregivers with lived experience raising a child with autism who have successfully completed facilitator training and competency assessment. | Behavioural | Peer-led Pepea Pamoja |
Primary outcome
Family Burden and Stress
Time frame: 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
Time frame: 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.
10 secondary outcomes
Quality of Life in Caregivers
Time frame: Baseline, post-intervention, and 3-month follow-up
Quality of Life in Children
Time frame: Baseline, post-intervention, and 3-month follow-up
Parenting Stress Index
Time frame: Baseline, post-intervention, and 3-month follow-up
Depressive Symptoms in Caregivers
Time frame: Baseline, post-intervention, and 3-month follow-up
Child Behavior Checklist (CBCL)
Time frame: Baseline, post-intervention, and 3-month follow-up
Observed Child Social Communication
Time frame: Baseline, post-intervention, and 3-month follow-up
Incremental Cost-Effectiveness Ratio (ICER)
Time frame: 3 months
Observed Caregiver-Child Interaction Quality
Time frame: Baseline, post-intervention, and 3-month follow-up
Observed Caregiver Strategy Use
Time frame: Baseline, post-intervention, and 3-month follow-up
Autism-Related Functioning
Time frame: Baseline, post-intervention, and 3-month follow-up.
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 31 Aug 2026.
- Background: PubMed 37253492McLay L, Emerson LM, Waddington H, van Deurs J, Hunter J, Blampied N, Hapuku A, Macfarlane S, Bowden N, van Noorden L, Rispoli M. Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial. BMJ Open. 2023 May 30;13(5):e071235. doi: 10.1136/bmjopen-2022-071235.
- Background: PubMed 38967420McNally Keehn R, Rispoli M, Saina C, Nafiseh A, Oyungu E, Omari FW, Kigen B, Hassinger T, Stewart L, Gross J, McHenry M. Pepea Pamoja:dagger Applying the Ecological Validity Framework to co-develop a wellbeing and behavioural training program for caregivers of young children with autism in low-resource settings of Kenya and the United States. Child Care Health Dev. 2024 Jul;50(4):e13299. doi: 10.1111/cch.13299.
- BackgroundVarni JW. PedsQL™ (Pediatric Quality of Life Inventory™). James W. Varni, Ph.D. Accessed September 18, 2025, https://www.pedsql.org
- BackgroundFerrell BRaG, Marcia. Quality of Life - Family Version. City of Hope National Medical Center and Beckman Research Institute. Accessed September 18, 2025, https://www.cityofhope.org/sites/www/files/2022-06/1431763601545-qol-family%20%282%29.pdf
- BackgroundAmerican Psychological Association. Caregiver Self-Assessment Questionnaire. American Psychological Association. Accessed September 18, 2025, https://www.apa.org/pi/about/publications/caregivers/practice-settings/assessment/tools/self-assessment
- Background: PubMed 33313580Mwangi P, Nyongesa MK, Koot HM, Cuijpers P, Newton CRJC, Abubakar A. Validation of a Swahili version of the 9-item Patient Health Questionnaire (PHQ-9) among adults living with HIV compared to a community sample from Kilifi, Kenya. J Affect Disord Rep. 2020 Dec;1:100013. doi: 10.1016/j.jadr.2020.100013.
- BackgroundWetherby AMaP, Barry M. CSBS™ - Communication and Symbolic Behavior Scales. Brookes Publishing Co. Accessed September 18, 2025, https://brookespublishing.com/product/csbs
- BackgroundRutter MB, Anthony; & Lord, Catherine. Social Communication Questionnaire (SCQ®). Western Psychological Services (WPS). Accessed September 18, 2025, https://www.wpspublish.com/scq-social-communication-questionnaire.html
- BackgroundAchenbach TM. Child Behavior Checklist for Ages 6-18 (CBCL/6-18). ASEBA, University of Vermont. Accessed September 18, 2025, https://aseba.org/wp-content/uploads/2019/02/schoolagecbcl.pdf
- Background: PubMed 33001561Mazurek MO, Carlson C, Baker-Ericzen M, Butter E, Norris M, Barr C, Kanne S. The Autism Impact Measure (AIM): Examination of Sensitivity to Change. Autism Res. 2020 Nov;13(11):1867-1879. doi: 10.1002/aur.2397. Epub 2020 Oct 1.
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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.
Eren Oyungu, MBChB principal investigator
Moi University
Megan S. McHenry, MD, MS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Professionally-facilitated groups and Peer-facilitated groups in people with Autism Spectrum Disorder and Autism, run by Indiana University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. 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: opening soon, as of the sponsor's last update on 31 Aug 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 Kenya. 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?
Contact Ananda Ombitsa (+254 718 748 223, rananda@ampath.or.ke), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Burden and Stress (time frame: Baseline, post-intervention, and 3-month follow-up). 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?
On the ClinicalTrials.gov record for NCT07259044, which also lists 10 linked publications.
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 31 Aug 2026.