- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07469514
Coaching, Learning, Empowerment in Cerebral Palsy - a 6-Week Integrated PT/OT Caregiver "Primer" Bootcamp for Infants Diagnosed With or at High Risk for Cerebral Palsy (CIRCLE-CP)
March 10, 2026 updated by: University of California, San Francisco
CIRCLE-CP Study: Coaching, Learning, Empowerment in Cerebral Palsy - a 6-Week Integrated PT/OT Caregiver "Primer" Bootcamp for Infants Diagnosed With or at High Risk for Cerebral Palsy
This study focuses on the caregiver's knowledge, comfort, and confidence in interacting with and supporting their infant with Cerebral Palsy (CP) or at high risk for Cerebral Palsy.
Four caregivers with their infants will be in one cohort to assess the benefits of group intervention.
The intervention is delivered in a group, bootcamp-style educational format led by clinical team including pediatric physiatrist, physical therapist and occupational therapist.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
This program aims to provide caregivers with structured education and practical skills related to early intervention of cerebral palsy.
Session content includes: (1) understanding the definition and nature of cerebral palsy; (2) the importance of early intervention and principles of infant neuroplasticity; and (3) foundational early motor strategies and CP-specific therapeutic principles commonly used in PT and OT.
Sessions incorporate therapist demonstration, caregiver coaching, and guided motor play with the infant.
In addition to knowledge-building, the intervention also aims to provide intentional caregiver support following the early diagnosis of CP, and achieves this via fostering peer support among families with similar experiences, and empowering caregivers in navigating and advocating within their child's early intervention system.
Outcomes will be assessed through pre- and post-intervention parental Likert-scale surveys measuring (1) caregiver perceived knowledge, comfort, and confidence interacting with their infant, (2) perceived benefit of the group program, and (3) caregiver readiness to actively engage in ongoing longitudinal CP-specific early intervention.
Study Type
Interventional
Enrollment (Estimated)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jasmine Ng, MD
- Phone Number: 510-428-3655
- Email: jasmine.ng@ucsf.edu
Study Locations
-
-
California
-
Oakland, California, United States, 94609
- UCSF Cerebral Palsy & Movement Disorders Center
-
Contact:
- Jasmine Ng, MD
- Phone Number: 510-428-3655
- Email: jasmine.ng@ucsf.edu
-
Principal Investigator:
- Jasmine Ng, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Infants 3-15 months corrected age at enrollment
- Diagnosed with CP or at high possibility of CP
- Not yet independently walking at baseline
- Medically stable for therapeutic handling and group play
- Primary caregiver (>=18years) able to attend all weekly group sessions
- English-speaking only
Exclusion Criteria:
- Unstable medical condition (eg, frequent desaturations, emeses, uncontrolled seizures) or acute restrictions incompatible with participation
- Concurrent enrollment in another intensive motor program
- Profound sensory impairments that preclude group program participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Caregiver-Infant
|
This study focuses on the caregiver's knowledge, comfort, and confidence in interacting with and supporting their infant with Cerebral Palsy (CP) or at high risk for Cerebral Palsy.
Demonstration and guided practice, caregiver-infant hands-on interaction practice, home exercise program, and support for strengthening parent-infant interaction on Cerebral Palsy basics.
Demonstration and guided practice, caregiver-infant hands-on interaction practice, home exercise program, and support for strengthening parent-infant interaction on Cerebral Palsy basics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver knowledge, comfort, and confidence
Time Frame: Baseline to 6 weeks.
|
Change from baseline in caregiver-perceived knowledge, comfort, and confidence in interacting with and supporting their infant with CP or high CP risk trhough integrated PT/OT caregiver-focused group intervention at 6 weeks.
|
Baseline to 6 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Group intervention
Time Frame: Baseline to 6 weeks.
|
Change from baseline in caregiver perceived benefit of the group intervention on Parental Survey at 6 weeks.
|
Baseline to 6 weeks.
|
|
Early Start
Time Frame: Baseline to 6 weeks.
|
Change from baseline readiness and acceptance of Early Start home-based early intervention services at 6 weeks.
|
Baseline to 6 weeks.
|
|
Feasibility of Groups
Time Frame: Baseline to 6 weeks.
|
Change from baseline feasibility and acceptability of the group program on Parental Survey at 6 weeks.
|
Baseline to 6 weeks.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver feedback
Time Frame: Baseline to 6 weeks.
|
Change from baseline in peer support, barriers, and suggested program improvements on Parental Survey at 6 weeks.
|
Baseline to 6 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jasmine Ng, MD, University of California San Frnacisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Svensson K, Sundelin H, Eliasson AC. Outcomes of a Parent-Delivered Baby-mCIMT Model for Infants at High Risk of Unilateral Cerebral Palsy Using Remote Coaching in Telerehabilitation. Children (Basel). 2024 Jan 15;11(1):101. doi: 10.3390/children11010101.
- Morgan C, Darrah J, Gordon AM, Harbourne R, Spittle A, Johnson R, Fetters L. Effectiveness of motor interventions in infants with cerebral palsy: a systematic review. Dev Med Child Neurol. 2016 Sep;58(9):900-9. doi: 10.1111/dmcn.13105. Epub 2016 Mar 29.
- Morgan C, Fetters L, Adde L, Badawi N, Bancale A, Boyd RN, Chorna O, Cioni G, Damiano DL, Darrah J, de Vries LS, Dusing S, Einspieler C, Eliasson AC, Ferriero D, Fehlings D, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Mak C, Maitre N, McIntyre S, Mei C, Morgan A, Kakooza-Mwesige A, Romeo DM, Sanchez K, Spittle A, Shepherd R, Thornton M, Valentine J, Ward R, Whittingham K, Zamany A, Novak I. Early Intervention for Children Aged 0 to 2 Years With or at High Risk of Cerebral Palsy: International Clinical Practice Guideline Based on Systematic Reviews. JAMA Pediatr. 2021 Aug 1;175(8):846-858. doi: 10.1001/jamapediatrics.2021.0878.
- Karstad SB, Bjorseth A, Lindstedt J, Brenne AS, Steihaug H, Elvrum AG. Parental Coping, Representations, and Interactions with Their Infants at High Risk of Cerebral Palsy. J Clin Med. 2022 Dec 29;12(1):277. doi: 10.3390/jcm12010277.
- Harniess PA, Gibbs D, Bezemer J, Purna Basu A. Parental engagement in early intervention for infants with cerebral palsy-A realist synthesis. Child Care Health Dev. 2022 May;48(3):359-377. doi: 10.1111/cch.12916. Epub 2021 Nov 1.
- Barfoot J, Meredith P, Ziviani J, Whittingham K. Parent-child interactions and children with cerebral palsy: An exploratory study investigating emotional availability, functional ability, and parent distress. Child Care Health Dev. 2017 Nov;43(6):812-822. doi: 10.1111/cch.12493. Epub 2017 Jul 23.
- Fernandez-Alcantara M, Garcia-Caro MP, Laynez-Rubio C, Perez-Marfil MN, Marti-Garcia C, Benitez-Feliponi A, Berrocal-Castellano M, Cruz-Quintana F. Feelings of loss in parents of children with infantile cerebral palsy. Disabil Health J. 2015 Jan;8(1):93-101. doi: 10.1016/j.dhjo.2014.06.003. Epub 2014 Jun 30.
- Lambrenos K, Weindling AM, Calam R, Cox AD. The effect of a child's disability on mother's mental health. Arch Dis Child. 1996 Feb;74(2):115-20. doi: 10.1136/adc.74.2.115.
- Festante F, Antonelli C, Chorna O, Corsi G, Guzzetta A. Parent-Infant Interaction during the First Year of Life in Infants at High Risk for Cerebral Palsy: A Systematic Review of the Literature. Neural Plast. 2019 Apr 15;2019:5759694. doi: 10.1155/2019/5759694. eCollection 2019.
- Eliasson AC, Sjostrand L, Ek L, Krumlinde-Sundholm L, Tedroff K. Efficacy of baby-CIMT: study protocol for a randomised controlled trial on infants below age 12 months, with clinical signs of unilateral CP. BMC Pediatr. 2014 Jun 5;14:141. doi: 10.1186/1471-2431-14-141.
- Zhou X, Li X, Jin M, Zhou X, Liang J, Zhu J, Meng Q, Du Q. The effects of environmental enrichment in infants with or at high risk of cerebral palsy: an updated systematic review and meta-analysis. BMC Pediatr. 2025 Aug 23;25(1):642. doi: 10.1186/s12887-025-05954-5.
- Basu AP. Early intervention for infants at high risk for cerebral palsy: evidently important, but where's the evidence? Dev Med Child Neurol. 2021 Jul;63(7):762. doi: 10.1111/dmcn.14875. Epub 2021 Apr 6. No abstract available.
- Damiano DL, Longo E. Early intervention evidence for infants with or at risk for cerebral palsy: an overview of systematic reviews. Dev Med Child Neurol. 2021 Jul;63(7):771-784. doi: 10.1111/dmcn.14855. Epub 2021 Apr 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
February 26, 2026
First Submitted That Met QC Criteria
March 10, 2026
First Posted (Actual)
March 13, 2026
Study Record Updates
Last Update Posted (Actual)
March 13, 2026
Last Update Submitted That Met QC Criteria
March 10, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-45652
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Ankara City Hospital BilkentRecruitingCerebral Palsy (CP) | Cerebral Palsy, Spastic, Diplegic | Diplegic Cerebral Palsy With Spasticity | Transcranial Magnetic StimilationTurkey (Türkiye)
-
Lahore University of Biological and Applied SciencesRecruiting
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)RecruitingCerebral Palsy (CP) | Hemiplegic Cerebral PalsyCanada
-
Cairo UniversityCompletedCerebral Palsy (CP) | Unilateral Cerebral PalsyEgypt
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
IRCCS Fondazione Stella MarisNot yet recruitingCerebral Palsy (CP) | EEG | Unilateral Cerebral Palsy | Action ObservationItaly
-
IRCCS Fondazione Stella MarisUniversity of Siena, ItalyRecruitingCerebral Palsy (CP) | Motor Imagery | CP (Cerebral Palsy) | Action ObservationItaly
-
University of LahoreCompletedCerebral Palsy (CP) | Spastic Diplegia Cerebral Palsy | Balance | Gross Motor FunctionsPakistan
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
Clinical Trials on Caregiver knowledge
-
Case Western Reserve UniversityNational Institute on Aging (NIA)Not yet recruitingDementia | Elder Abuse | Caregiving | Quality of Care | Elder MistreatmentUnited States
-
Northwestern UniversityNational Institute on Aging (NIA)CompletedCognitive Impairment | Alzheimer DiseaseUnited States
-
Sunnybrook Health Sciences CentreScarborough General Hospital; Michael Garron Hospital; York Central Hospital,... and other collaboratorsCompleted
-
Swiss Tropical & Public Health InstituteWorld BankActive, not recruitingCompliant Behavior | Morbidity;InfantSwitzerland, Congo, The Democratic Republic of the
-
Tan Tock Seng HospitalRecruitingCaregiver | Caregiver Stress | Caregiver Resilience and StressSingapore
-
Eunice Kennedy Shriver National Institute of Child...Autism SpeaksCompletedAutism Spectrum DisorderUnited States
-
Rush University Medical CenterNational Institute on Aging (NIA)Active, not recruitingLewy Body Disease | Dementia With Lewy Bodies | Lewy Body Dementia | Parkinson Disease DementiaUnited States
-
US Department of Veterans AffairsCompleted
-
University of MiamiNational Institute on Disability, Independent Living, and Rehabilitation...CompletedCardiovascular Diseases | Obesity | Spinal Cord InjuryUnited States
-
University of Alabama at BirminghamUnited States Department of Defense; Congressionally Directed Medical Research...CompletedDementia | Traumatic Brain InjuryUnited States