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

NCT07469514 | Not Yet Recruiting

• 1 other identifier: 25-45652
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. The intervention is delivered in a group, bootcamp-style educational format led by clinical team including pediatric physiatrist, physical therapist and occupational therapist.

Conditions

Cerebral Palsy; Cerebral Palsy (CP); Cerebral Palsy Infantile; Infant

Keywords

physical therapy; occupational therapy; caregivers; caregiver

Outcome Measures

Primary Outcomes (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.

  Baseline to 6 weeks.

Secondary Outcomes (3)

• Group intervention

  Baseline to 6 weeks.

• Early Start

  Baseline to 6 weeks.

• Feasibility of Groups

  Baseline to 6 weeks.

Other Outcomes (1)

• Caregiver feedback

  Baseline to 6 weeks.

Study Arms (1)

Caregiver-Infant

OTHER

Behavioral: Caregiver knowledge; Behavioral: Physical therapy; Behavioral: Occupational Therapy

Interventions

Caregiver knowledge BEHAVIORAL

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.

Caregiver-Infant

Physical therapy BEHAVIORAL

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

Caregiver-Infant

Occupational Therapy BEHAVIORAL

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

Caregiver-Infant

Eligibility Criteria

• Age: 3 Months - 15 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Cerebral Palsy & Movement Disorders Center

Oakland, California, 94609, United States

Location

Related Publications (13)

• 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.

  PMID: 36615077 BACKGROUND

• 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.

  PMID: 34622968 BACKGROUND

• 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.

  PMID: 28737004 BACKGROUND

• 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.

  PMID: 25096631 BACKGROUND

• 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.

  PMID: 8660072 BACKGROUND

• 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.

  PMID: 31178902 BACKGROUND

• 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.

  PMID: 38255414 BACKGROUND

• 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.

  PMID: 24903062 BACKGROUND

• 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.

  PMID: 27027732 BACKGROUND

• 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.

  PMID: 40847391 BACKGROUND

• 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.

  PMID: 33825191 BACKGROUND

• 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.

  PMID: 33825199 BACKGROUND

• 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.

  PMID: 33999106 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities; Occupational Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Jasmine Ng, MD

  University of California San Frnacisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasmine Ng, MD

CONTACT

510-428-3655; jasmine.ng@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4 caregivers and their infant will be in one group. There will be a total of 4 groups.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)