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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-15
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Caregiver-InfantOther 3 interventions

Trial outcomes

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.

Time frame
Baseline to 6 weeks.

Secondary outcomes

1

Group intervention

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

Time frame
Baseline to 6 weeks.
2

Early Start

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

Time frame
Baseline to 6 weeks.
3

Feasibility of Groups

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

Time frame
Baseline to 6 weeks.

Other outcomes

1

Caregiver feedback

Change from baseline in peer support, barriers, and suggested program improvements on Parental Survey at 6 weeks.

Time frame
Baseline to 6 weeks.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: