Reading Disorder, DevelopmentalNCT06442098
Camp SMART Speech to Print Summer Literacy Camp
A study testing CAMP SMART Literacy Summer Camp in people with Reading Disorder, Developmental, run by San Diego State University at 1 site in United States.
Trial summary
This project aims to explore the feasibility and efficacy of a 6-week, intensive summer literacy intervention provided to children in 1st-3rd grades. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Reading Disorder, Developmental
- What is being tested?
- CAMP SMART Literacy Summer Camp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2024to 8 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Students who are in the summer after Kindergarten, first, or second grade.
- Students from the local community who either a) have IEPs with eligibility of SLI or SLD-reading or b) have documented parent or teacher concern for reading and/or language skills as determined by parent questionnaire.
- Children who fit the above criteria will additionally be determined eligible for the intervention based on language or reading composite skills one or more standard deviations below the mean on the Test of Integrated Language and Literacy Skills (TILLS).
- Children who are rising 4th, 5th, or 6th graders and who have an IEP with eligibility of SLI or SLD-Reading and who demonstrate composite scores one or more standard deviations below the mean on the TILLS may be considered if space remains after recruitment of 1st-3rd graders.
Who cannot join
- Students who do not either a) have an IEP or b) have documented parent or teacher concern based on parent questionnaire.
- Students who score within the typical range on the TILLS.
- Students who are deaf or blind.
Trial locations and contacts
1 site in 1 country.
United States1 site
SDSU Speech, Language, and Hearing Clnic
San Diego, California, 92182
About this study
This project aims to explore the feasibility and efficacy of a 6-week, intensive summer literacy intervention provided to children in 1st-3rd grades.
Read the detailed description
- Purpose/objective: To determine the feasibility and preliminary effectiveness of a 6-week literacy summer camp for improving language and literacy outcomes of children with identified language or literacy difficulties.
- Methods: This intervention will be provided by students in the speech and hearing clinic on SDSU's campus. The summer clinical sessions last for 8 weeks. Week 1 will be used for the pre-testing of each participant's baseline language (morphological awareness, phonological awareness, morphosyntax, vocabulary, and narrative language skills) and reading (letter knowledge, nonword reading, reading fluency and reading comprehension). In weeks 2-7, the intervention will take place. This will consist of 3, 3-hour sessions per week. Finally, in week 8, the investigators will conduct post-testing of children's language and reading skills.
- Subjects: The investigators will recruit a maximum of 12 students who are in the summer after Kindergarten, first, or second grade. The investigators will be recruiting students from the local community who either a) have IEPs with eligibility of SLI or SLD-reading or b) have documented parent or teacher concern for reading and/or language skills as determined by parent questionnaire.
- Planned analyses:
Planned analyses will include analysis of improvement in each of the language and reading skills from pre-test to post-test. The investigators will also include probes of performance of reading skills to allow for single subject analysis. The investigators will develop fidelity rubrics to explore the fidelity of intervention implementation and will analyze how fidelity relates to individual-child-level improvement.
- Conditions
- Reading Disorder, Developmental
- Being tested
- CAMP SMART Literacy Summer Camp
- Keywords
- Literacy Intervention
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAMP SMART Literacy Summer CampBehavioural
Multimodal approach to reading intervention
| Study group | Role | What they receive |
|---|---|---|
| Code First | Experimental | Children in this condition will receive 7 sessions of code-focused reading intervention followed by 7 sessions of morphology-focused reading intervention. Receives: Behavioral: CAMP SMART Literacy Summer Camp |
| Morphology First | Experimental | Children in this condition will receive 7 sessions of morphology-focused reading intervention followed by 7 sessions of code-focused reading intervention. Receives: Behavioral: CAMP SMART Literacy Summer Camp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spelling Probes
Experimenter-created lists of CVC words that children will be asked to spell
Measured: Children will spell 10 CVC words at the conclusion of each of their 14 intervention sessions. Their performance will be charted and tracked.
Secondary outcomes (1)
Test of Integrated Language and Literacy Skills standard score
Standardized measure of language and reading skills that assesses real and non-word reading and spelling as well as oral language skills in English.
Measured: Administered prior to the initiation of the intervention and upon conclusion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start11 Jun 2024
- Primary completion1 Aug 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reading Disorder, DevelopmentalStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Alternating Treatment Single Subject Design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442098
- Sponsor's protocol ID
- HS-2024-0077
- Status last verified
- Oct 2024
- First submitted
- 9 May 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camp SMART Speech to Print Summer Literacy Camp
- ClinicalTrials.gov ID
- NCT06442098
- Acronym / sponsor ID
- HS-2024-0077
- Conditions
- Reading Disorder, Developmental
- Keywords
- Literacy Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to explore the feasibility and efficacy of a 6-week, intensive summer literacy intervention provided to children in 1st-3rd grades.
Detailed description
- Purpose/objective: To determine the feasibility and preliminary effectiveness of a 6-week literacy summer camp for improving language and literacy outcomes of children with identified language or literacy difficulties.
- Methods: This intervention will be provided by students in the speech and hearing clinic on SDSU's campus. The summer clinical sessions last for 8 weeks. Week 1 will be used for the pre-testing of each participant's baseline language (morphological awareness, phonological awareness, morphosyntax, vocabulary, and narrative language skills) and reading (letter knowledge, nonword reading, reading fluency and reading comprehension). In weeks 2-7, the intervention will take place. This will consist of 3, 3-hour sessions per week. Finally, in week 8, the investigators will conduct post-testing of children's language and reading skills.
- Subjects: The investigators will recruit a maximum of 12 students who are in the summer after Kindergarten, first, or second grade. The investigators will be recruiting students from the local community who either a) have IEPs with eligibility of SLI or SLD-reading or b) have documented parent or teacher concern for reading and/or language skills as determined by parent questionnaire.
- Planned analyses:
Planned analyses will include analysis of improvement in each of the language and reading skills from pre-test to post-test. The investigators will also include probes of performance of reading skills to allow for single subject analysis. The investigators will develop fidelity rubrics to explore the fidelity of intervention implementation and will analyze how fidelity relates to individual-child-level improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Alternating Treatment Single Subject Design
| Arm | Type | Receives |
|---|---|---|
| Code First | Experimental | Behavioral: CAMP SMART Literacy Summer CampChildren in this condition will receive 7 sessions of code-focused reading intervention followed by 7 sessions of morphology-focused reading intervention. |
| Morphology First | Experimental | Behavioral: CAMP SMART Literacy Summer CampChildren in this condition will receive 7 sessions of morphology-focused reading intervention followed by 7 sessions of code-focused reading intervention. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Students who are in the summer after Kindergarten, first, or second grade.
- Students from the local community who either a) have IEPs with eligibility of SLI or SLD-reading or b) have documented parent or teacher concern for reading and/or language skills as determined by parent questionnaire.
- Children who fit the above criteria will additionally be determined eligible for the intervention based on language or reading composite skills one or more standard deviations below the mean on the Test of Integrated Language and Literacy Skills (TILLS).
- Children who are rising 4th, 5th, or 6th graders and who have an IEP with eligibility of SLI or SLD-Reading and who demonstrate composite scores one or more standard deviations below the mean on the TILLS may be considered if space remains after recruitment of 1st-3rd graders.
Key exclusion criteria (3 listed)
- Students who do not either a) have an IEP or b) have documented parent or teacher concern based on parent questionnaire.
- Students who score within the typical range on the TILLS.
- Students who are deaf or blind.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAMP SMART Literacy Summer CampMultimodal approach to reading intervention | Behavioural | Code First, Morphology First |
Primary outcome
Spelling Probes
Time frame: Children will spell 10 CVC words at the conclusion of each of their 14 intervention sessions. Their performance will be charted and tracked.
Experimenter-created lists of CVC words that children will be asked to spell
1 secondary outcome
Test of Integrated Language and Literacy Skills standard score
Time frame: Administered prior to the initiation of the intervention and upon conclusion of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAMP SMART Literacy Summer Camp in people with Reading Disorder, Developmental, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spelling Probes (time frame: Children will spell 10 CVC words at the conclusion of each of their 14 intervention sessions. Their performance will be charted and tracked.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.