Neurofibromatosis 1NCT04860362
Pilot Randomized Control Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1
A study testing PEERS in people with Neurofibromatosis 1 and Social Skills, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial summary
This is a pilot randomized control trial of the UCLA PEERS protocol delivered via Telehealth with teens with neurofibromatosis type 1 whose parents report that they have difficulty making and keeping friends. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurofibromatosis 1, Social Skills
- What is being tested?
- PEERS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2021to Aug 2022
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Physician diagnosis of neurofibromatosis type 1
- Age 12-17
- Main language spoken in the home is English
- Reliable internet access
- Current functional impairment in peer relationships
- Teen is interested and motivated to participate
Who cannot join
- Main language spoken in the home is not English
- Cognitive or developmental difficulties that affect reading comprehension or understanding of treatment material
- Significant behavioral concerns
- Other comorbid medical conditions
- Major surgery in past 6 months
- Prior social skills group treatment within past 6 months
- Prior participation in PEERS
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, 53201
Bonita Klein-Tasman, PhD, 414-229-3060, bklein@uwm.edu
About this study
Official title: Effectiveness of a Telehealth Group for Improving Peer Relationships for Adolescents With Neurofibromatosis Type 1
This is a pilot randomized control trial of the UCLA PEERS protocol delivered via Telehealth with teens with neurofibromatosis type 1 whose parents report that they have difficulty making and keeping friends.
- Conditions
- Neurofibromatosis 1, Social Skills
- Being tested
- PEERS
- Medical subject headings
- Neurofibromatosis 1, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEERSBehavioural
Also called Program for the Education and Enrichment of Relational Skills
Structured social skills curriculum including didactics, behavioral rehearsal, parent coaching, and parent coaching support.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | PEERS weekly sessions - parallel teens and parent/caregiver groups Receives: Behavioral: PEERS |
| Wait List Control | Other | Offered intervention at a later date Receives: Behavioral: PEERS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent
Change from pre- to post-test on SSIS-SEL parent Total Standard Score (measures social functioning)
Measured: within 4 weeks of PEERS completion
Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)
Change from pre- to post-test on total score (measures knowledge of the PEERS concepts)
Measured: within four weeks of PEERS completion
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent
Change from pre- to 16 week followup on total score
Measured: 16 weeks following PEERS completion
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent
Amount of change from pre- to post-test differs from change in Wait List Control group
Measured: within four weeks of PEERS completion for treatment group
Secondary outcomes (4)
Social Responsiveness Scale -2 (SRS-2; Constantino, 2005)
change from pre- to post-test on Total SRS-2 completed by caregivers (measure of social impairment)
Measured: within 4 weeks following PEERS completion
Social Responsiveness Scale -2 (SRS-2; Constantino, 2005)
change from pre- to 16 week followup on Total SRS-2 completed by caregivers (measure of social impairment)
Measured: 16 weeks following PEERS completion
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen
Change from pre- to post-test on teen self-report of social functioning
Measured: within 4 weeks of PEERS completion
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen
Change from pre- to 16 week followup on teen self-report of social functioning
Measured: 16 weeks following PEERS completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start29 Jan 2021
- Primary completionSep 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurofibromatosis 1Studies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Collaborators
- NF Midwest, NF Northeast
- Responsible party
- Principal investigator, Bonita P Klein-Tasman, University of Wisconsin, Milwaukee
- Investigators
- Bonnie Klein-Tasman, PhD, Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860362
- Sponsor's protocol ID
- 21-039-UWM-b
- Status last verified
- Apr 2021
- First submitted
- 19 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be available upon request to qualified investigators.
Publications
Glad DM, Pardej SK, Olszewski E, Klein-Tasman BP. Feasibility and acceptability of a telehealth intervention for improving peer relationships for adolescents with neurofibromatosis type 1: a single-arm pilot study. J Pediatr Psychol. 2024 Sep 1;49(9):647-655. doi: 10.1093/jpepsy/jsae050.
PubMed 38908005
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Telehealth Group for Improving Peer Relationships for Adolescents With Neurofibromatosis Type 1
- ClinicalTrials.gov ID
- NCT04860362
- Acronym / sponsor ID
- 21-039-UWM-b
- Conditions
- Neurofibromatosis 1, Social Skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Collaborators
- NF Midwest, NF Northeast
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 26 Apr 2021 (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 is a pilot randomized control trial of the UCLA PEERS protocol delivered via Telehealth with teens with neurofibromatosis type 1 whose parents report that they have difficulty making and keeping friends.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: PEERSPEERS weekly sessions - parallel teens and parent/caregiver groups |
| Wait List Control | Other | Behavioral: PEERSOffered intervention at a later date |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Physician diagnosis of neurofibromatosis type 1
- Age 12-17
- Main language spoken in the home is English
- Reliable internet access
- Current functional impairment in peer relationships
Key exclusion criteria (7 listed)
- Main language spoken in the home is not English
- Cognitive or developmental difficulties that affect reading comprehension or understanding of treatment material
- Significant behavioral concerns
- Other comorbid medical conditions
- Major surgery in past 6 months
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 |
|---|---|---|
| PEERSAlso: Program for the Education and Enrichment of Relational SkillsStructured social skills curriculum including didactics, behavioral rehearsal, parent coaching, and parent coaching support. | Behavioural | Treatment, Wait List Control |
Primary outcome
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent
Time frame: within 4 weeks of PEERS completion
Change from pre- to post-test on SSIS-SEL parent Total Standard Score (measures social functioning)
Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)
Time frame: within four weeks of PEERS completion
Change from pre- to post-test on total score (measures knowledge of the PEERS concepts)
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent
Time frame: 16 weeks following PEERS completion
Change from pre- to 16 week followup on total score
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent
Time frame: within four weeks of PEERS completion for treatment group
Amount of change from pre- to post-test differs from change in Wait List Control group
4 secondary outcomes
Social Responsiveness Scale -2 (SRS-2; Constantino, 2005)
Time frame: within 4 weeks following PEERS completion
Social Responsiveness Scale -2 (SRS-2; Constantino, 2005)
Time frame: 16 weeks following PEERS completion
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen
Time frame: within 4 weeks of PEERS completion
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen
Time frame: 16 weeks following PEERS completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Derived from this study: PubMed 38908005Glad DM, Pardej SK, Olszewski E, Klein-Tasman BP. Feasibility and acceptability of a telehealth intervention for improving peer relationships for adolescents with neurofibromatosis type 1: a single-arm pilot study. J Pediatr Psychol. 2024 Sep 1;49(9):647-655. doi: 10.1093/jpepsy/jsae050.
- Individual participant dataSharing planned: Yes. Deidentified data will be available upon request to qualified investigators.
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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.
Bonnie Klein-Tasman, PhD principal investigator
University of Wisconsin, Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEERS in people with Neurofibromatosis 1 and Social Skills, run by University of Wisconsin, Milwaukee 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bonita P Klein-Tasman, PhD (414-229-3060, bklein@uwm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent (time frame: within 4 weeks of PEERS completion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04860362, which also lists 1 linked publication.
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 26 Apr 2021.