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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Caregiver knowledge
  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.
• Поведенческое Physical therapy
  Demonstration and guided practice, caregiver-infant hands-on interaction practice, home exercise program, and support for strengthening parent-infant interaction on Cerebral Palsy basics.
• Поведенческое Occupational Therapy
  Demonstration and guided practice, caregiver-infant hands-on interaction practice, home exercise program, and support for strengthening parent-infant interaction on Cerebral Palsy basics.

Первичные конечные точки

• Caregiver knowledge, comfort, and confidence [Срок оценки: Baseline to 6 weeks.]

Вторичные конечные точки (3)

• Group intervention [Срок оценки: Baseline to 6 weeks.]
• Early Start [Срок оценки: Baseline to 6 weeks.]
• Feasibility of Groups [Срок оценки: Baseline to 6 weeks.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UCSF Cerebral Palsy & Movement Disorders Center — Oakland

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07469514 · 25-45652

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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