Fidelity of Delivery in a Multisite Randomized Clinical Trial of Intervention Efficacy for Infants With Unilateral
Kimberley Scott1, Leanne Sakzewski, Jenny Ziviani
1Department of Physical Therapy (Dr Scott), Creighton University, Omaha, Nebraska; Queensland Cerebral Palsy and Rehabilitation Research Centre (Drs Sakzewski and Boyd), Child Health Research Centre, Faculty of Medicine, and School of Health and Rehabilitation Sciences (Dr Ziviani), The University of Queensland, Brisbane, Queensland, Australia; Division of Physical Therapy (Dr Heathcock), The Ohio State University, Columbus, Ohio.
Insights
Therapist fidelity in the Rehabilitation EArly for Congenital Hemiplegia (REACH) trial was high, with the Therapist Fidelity Checklist (TFC) showing good reliability. Standardized training and support likely ensured consistent intervention delivery.
Area of Science:
- Pediatric Rehabilitation
- Clinical Trial Methodology
- Neurodevelopmental Disorders
Background:
- Congenital hemiplegia significantly impacts child development.
- Early intervention is crucial for improving outcomes in infants with unilateral cerebral palsy.
- Ensuring consistent and high-quality therapist delivery is vital for intervention efficacy.
Purpose of the Study:
- To assess the reliability and quantify the fidelity of therapist delivery in the Rehabilitation EArly for Congenital Hemiplegia (REACH) clinical trial.
- To identify factors influencing therapist fidelity during early intervention for congenital hemiplegia.
- To validate the Therapist Fidelity Checklist (TFC) as a measure of intervention adherence.
Main Methods:
- Ninety-five infants (3-9 months) with unilateral cerebral palsy participated in the REACH trial.
- Therapist delivery was evaluated using the Therapist Fidelity Checklist (TFC) on video-recorded sessions.
- Inter- and intrarater reliability of the TFC was calculated using percentage agreement.
Main Results:
- The TFC demonstrated good inter- and intrarater reliability (77%-100% agreement).
- High fidelity of delivery was observed in 88.9% of intervention sessions.
- Moderate fidelity was noted in 11.1% of sessions, particularly those involving infant-friendly bimanual therapy later in the intervention period.
Conclusions:
- High fidelity of therapist delivery was achieved in the majority of REACH trial sessions.
- Standardized therapist training and ongoing peer support were likely key factors in maintaining high fidelity.
- The TFC is a reliable tool for measuring and ensuring intervention fidelity in pediatric rehabilitation trials.
Purpose:
To investigate the reliability of a measure of fidelity of therapist delivery, quantify fidelity of delivery, and determine factors impacting fidelity in the Rehabilitation EArly for Congenital Hemiplegia (REACH) clinical trial.
Methods:
Ninety-five infants (aged 3-9 months) with unilateral cerebral palsy participated in the REACH clinical trial. The Therapist Fidelity Checklist (TFC) evaluated key intervention components. Video-recorded intervention sessions were scored using the TFC.
Results:
Inter- and intrarater reliability was percentage agreement 77% to 100%. Fidelity of delivery was high for 88.9% of sessions and moderate for 11.1% of sessions. Sessions with moderate scores included infants receiving infant-friendly bimanual therapy and occurred at the intervention midpoint or later. No significant relationships were found for TFC scores and infant age, manual ability, or parent engagement.
Conclusions:
Fidelity of delivery was high for the REACH trial in most intervention sessions. Standardized therapist training with intervention manuals and monthly peer-to-peer support likely contributed to these results.
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