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Cerebral PalsyCIRCLE-CPNCT07469514

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

A study testing Caregiver knowledge, Physical therapy and Occupational Therapy in people with Cerebral Palsy and Cerebral Palsy (CP), run by University of California, San Francisco at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 3 to 15 months
What is being tested?
Caregiver knowledge, Physical therapy and Occupational Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
Sep 2026to Apr 2027
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 3 to 15 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jasmine Ng, MD contact

510-428-3655

jasmine.ng@ucsf.edu

United States1 site

  • UCSF Cerebral Palsy & Movement Disorders Center

    Oakland, California, 94609

    Jasmine Ng, MD, 510-428-3655, jasmine.ng@ucsf.edu

    Jasmine Ng, MD

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Caregiver knowledge, Physical therapy, Occupational Therapy
Keywords
physical therapy, occupational therapy, caregivers, caregiver
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caregiver knowledgeBehavioural

    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.

  • Physical therapyBehavioural

    Demonstration and guided practice, caregiver-infant hands-on interaction practice, home exercise program, and support for strengthening parent-infant interaction on Cerebral Palsy basics.

  • Occupational TherapyBehavioural

    Demonstration and guided practice, caregiver-infant hands-on interaction practice, home exercise program, and support for strengthening parent-infant interaction on Cerebral Palsy basics.

Study groups in NCT07469514
Study groupRoleWhat they receive
Caregiver-InfantOtherNot described
Receives: Behavioral: Caregiver knowledge; Behavioral: Physical therapy; Behavioral: Occupational Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Caregiver knowledge, comfort, and confidence

    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.

    Measured: Baseline to 6 weeks.

Secondary outcomes (3)

  1. Group intervention

    Change from baseline in caregiver perceived benefit of the group intervention on Parental Survey at 6 weeks.

    Measured: Baseline to 6 weeks.

  2. Early Start

    Change from baseline readiness and acceptance of Early Start home-based early intervention services at 6 weeks.

    Measured: Baseline to 6 weeks.

  3. Feasibility of Groups

    Change from baseline feasibility and acceptability of the group program on Parental Survey at 6 weeks.

    Measured: Baseline to 6 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
4 caregivers and their infant will be in one group. There will be a total of 4 groups.
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07469514
Sponsor's protocol ID
25-45652
Acronym
CIRCLE-CP
Status last verified
Jul 2026
First submitted
26 Feb 2026
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36615077

  • 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.

    PubMed 34622968

  • 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.

    PubMed 28737004

  • 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.

    PubMed 25096631

  • 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.

    PubMed 8660072

  • 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.

    PubMed 31178902

  • 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.

    PubMed 38255414

  • 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.

    PubMed 24903062

  • 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.

    PubMed 27027732

  • 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.

    PubMed 40847391

  • 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.

    PubMed 33825191

  • 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.

    PubMed 33825199

  • 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.

    PubMed 33999106

Questions about this trial

What is this clinical trial studying?

A study testing Caregiver knowledge, Physical therapy and Occupational Therapy in people with Cerebral Palsy and Cerebral Palsy (CP), run by University of California, San Francisco at 1 site in United States.

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 6 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 14 Jul 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 United States. 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 Jasmine Ng, MD (510-428-3655, jasmine.ng@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caregiver knowledge, comfort, and confidence (time frame: Baseline to 6 weeks.). 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 NCT07469514, which also lists 13 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 14 Jul 2026.

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CIRCLE-CP Clinical Trial NCT07469514 | AzTrials