Evidence map›Paper›PMID 32316911›Full record

Trial reportJournal of neurodevelopmental disorders2020

Controlled trial of lovastatin combined with an open-label treatment of a parent-implemented language intervention in youth with fragile X syndrome.

Angela John Thurman, Laura A Potter, Kyoungmi Kim, Flora Tassone, Amy Banasik, Sarah Nelson Potter, Lauren Bullard, Vivian Nguyen, Andrea McDuffie, Randi Hagerman and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neurodevelopmental disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02642653 (Combining Lovastatin and a Parent-Implemented Language Intervention in a Multimodal Treatment for Fragile X Syndrome), which is not on this map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
7.6field-weighted citation impact, top 2% of its field
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.

NCT02642653 phase4completednot on this map

Combining Lovastatin and a Parent-Implemented Language Intervention in a Multimodal Treatment for Fragile X Syndrome

TypeinterventionalSponsorUniversity of California, DavisRan2016 to 2018Enrolled30ConditionsFragile X Syndrome, Genetic DiseasesArmsLovastatin, Placebo
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Effects of AFQ056 on language learning in fragile X syndrome.The Journal of clinical investigation · 2023
    Trial
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  6. Review
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  15. Review
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  18. Review
  19. Article
  20. Targeted Treatments for Fragile X Syndrome.Advances in neurobiology · 2023
    Article
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

11 authors at 1 institution in 1 country.

Angela John ThurmanMIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA. ajthurman@ucdavis.edu.
Laura A PotterMIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.
Kyoungmi KimMIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.
Flora TassoneMIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.
Amy BanasikMIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.
Sarah Nelson PotterMIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.
Lauren BullardMIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.
Vivian NguyenMIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.
Andrea McDuffieMIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.
Randi HagermanMIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.
Leonard AbbedutoMIND Institute, University of California Davis Health, 2825 50th Street, Room 2335, Sacramento, CA, 95817, USA.
University of California, Davis · US

Funding

UC Davis Clinical and Translational Science CenterUL1TR000002 · NCATS · UNIVERSITY OF CALIFORNIA AT DAVIS · PI BERGLUND, LARS F · 2012 to 2015
$12.2M
Rodent Behavior CoreU54HD079125 · NICHD · UNIVERSITY OF CALIFORNIA AT DAVIS · PI ABBEDUTO, LEONARD J. · 2013 to 2019
$8.5M
NCATS NIH HHS UL1 TR000002NICHD NIH HHS U54 HD079125
6 · The paper itself

Abstract

backgroundThe purpose of this study was to conduct a 20-week controlled trial of lovastatin (10 to 40 mg/day) in youth with fragile X syndrome (FXS) ages 10 to 17 years, combined with an open-label treatment of a parent-implemented language intervention (PILI), delivered via distance video teleconferencing to both treatment groups, lovastatin and placebo.

methodA randomized, double-blind trial was conducted at one site in the Sacramento, California, metropolitan area. Fourteen participants were assigned to the lovastatin group; two participants terminated early from the study. Sixteen participants were assigned to the placebo group. Lovastatin or placebo was administered orally in a capsule form, starting at 10 mg and increasing weekly or as tolerated by 10 mg increments, up to a maximum dose of 40 mg daily. A PILI was delivered to both groups for 12 weeks, with 4 activities per week, through video teleconferencing by an American Speech-Language Association-certified Speech-Language Pathologist, in collaboration with a Board-Certified Behavior Analyst. Parents were taught to use a set of language facilitation strategies while interacting with their children during a shared storytelling activity. The main outcome measures included absolute change from baseline to final visit in the means for youth total number of story-related utterances, youth number of different word roots, and parent total number of story-related utterances.

resultsSignificant increases in all primary outcome measures were observed in both treatment groups. Significant improvements were also observed in parent reports of the severity of spoken language and social impairments in both treatment groups. In all cases, the amount of change observed did not differ across the two treatment groups. Although gains in parental use of the PILI-targeted intervention strategies were observed in both treatment groups, parental use of the PILI strategies was correlated with youth gains in the placebo group and not in the lovastatin group.

conclusionParticipants in both groups demonstrated significant changes in the primary outcome measures. The magnitude of change observed across the two groups was comparable, providing additional support for the efficacy of the use of PILI in youth with FXS.

trial registrationUS National Institutes of Health (ClinicalTrials.gov), NCT02642653. Registered 12/30/2015.

Indexed as

AdolescentCaliforniaChildCommunicationDouble-Blind MethodFemaleFragile X SyndromeHumansLanguageLanguage TherapyLovastatinMaleMothersOutcome Assessment, Health CareTelecommunicationsLovastatinDistance teleconferencingExpressive language samplingFragile X syndromeLovastatinNarrative storytellingParent-implemented language interventionPILI

Identifiers

PMID32316911
PMCPMC7175541
OpenAlexW3016332336

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.