Evidence map›Paper›PMID 36731289›Full record

Trial reportEpilepsy & behavior : E&B2023

Pilot randomized controlled clinical trial of an adherence social norms intervention for adolescents with epilepsy.

Avani C Modi, Anup D Patel, Constance A Mara, Matthew Schmidt, Jeffrey R Tenney, Jack Stevens

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Epilepsy & behavior : E&B, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Avani C ModiDivision of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 3333 Burnet Ave., Cincinnati, OH 45229, United States; University of Cincinnati, College of Medicine, Cincinnati, OH, United States. Electronic address: avani.modi@cchmc.org.
Anup D PatelNationwide Children's Hospital, 700 Children's Drive, Near East Office Building, 3rd Floor, Columbus, OH 43205, United States; The Ohio State, Department of Pediatrics, 700 Children's Drive, Near East Office Building, 3rd Floor, Columbus, OH 43205, United States. Electronic address: anup.patel@nationwidechildrens.org.
Constance A MaraDivision of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 3333 Burnet Ave., Cincinnati, OH 45229, United States; University of Cincinnati, College of Medicine, Cincinnati, OH, United States. Electronic address: constance.mara@cchmc.org.
Matthew SchmidtCollege of Education, University of Florida, 2423 Normal Hall, Gainesville, FL 32611, United States. Electronic address: matthew.schmidt@coe.ufl.edu.
Jeffrey R TenneyDivision of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 3333 Burnet Ave., Cincinnati, OH 45229, United States; University of Cincinnati, College of Medicine, Cincinnati, OH, United States. Electronic address: jeffrey.tenney@cchmc.org.
Jack StevensNationwide Children's Hospital, 700 Children's Drive, Near East Office Building, 3rd Floor, Columbus, OH 43205, United States; The Ohio State, Department of Pediatrics, 700 Children's Drive, Near East Office Building, 3rd Floor, Columbus, OH 43205, United States. Electronic address: jack.stevens@nationwidechildrens.org.

Funding

Improving Drug Adherence Using mHealth and Behavioral Economics in Adolescents with EpilepsyR21NR017633 · NINR · CINCINNATI CHILDRENS HOSP MED CTR · PI MODI, AVANI C · 2018 to 2019
$448k
NINR NIH HHS R21 NR017633
6 · The paper itself

Abstract

objectiveNon-adherence to anti-seizure medications (ASMs) is common for adolescents with epilepsy, with potentially devastating consequences. Existing adherence interventions in epilepsy do not meet the unique challenges faced by adolescents. Leveraging social norms capitalizes on the increased importance of peer influence while simultaneously targeting the low motivation levels of many adolescents. The current study examined the feasibility, acceptability, and satisfaction of a social norms adherence intervention in adolescents with epilepsy.

methodsA pilot RCT of a mHealth social norms intervention was conducted with adolescents with epilepsy who demonstrated non-adherence (≤95% adherence) during baseline. Adolescents were randomized to either (1) mHealth social norms (reminders, individualized and social norms adherence feedback) or (2) control (reminders and individualized adherence feedback). Primary outcomes included feasibility, acceptability, and satisfaction. Exploratory outcomes included electronically monitored adherence, seizure severity, and health-related quality of life (HRQOL).

resultsOne hundred four adolescents were recruited (53% female; M

conclusionThis pilot intervention appeared feasible and acceptable. Increases in adherence in the treatment versus control group were modest, but a future larger more adequately powered study is needed to detect effects. Notably, it appeared the COVID pandemic influenced adherence behaviors during our trial.

Indexed as

COVID-19EpilepsyAdolescentFemaleHumansMalePilot ProjectsQuality of LifeSocial NormsAntiepileptic drugsBehavioral interventionComplianceSeizureYouth

Identifiers

PMID36731289
PMCPMC9998352

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.