An interventional study of Unstuck and On Target! in Neurofibromatosis 1 (NF1), Executive Function (Cognition) and Cognitive Intervention, sponsored by The Hospital for Sick Children. Not yet recruiting. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Treatment
Psychological interventions have been shown to be effective for managing cognitive and mental health challenges in different patient populations. The investigators are testing whether such a problem-solving skills program is effective and beneficial for children and teens with NF1 when implemented in a real-world setting. Unstuck and On Target! (UOT) is a comprehensive manualized intervention program that targets executive functioning (EF), self-determination, autonomy, quality of life, and mental health, as well as impact on parental stress. It has demonstrated effectiveness at improving EF in youth with autism. The investigators are assessing the effectiveness of the program in youth with NF1 and adapting the program for NF1, as needed, based on participant feedback.
221 studies on the registry are indexed under Neurofibromatosis 1; 44 are open to participants now.
This study's planned enrollment of 60 is above the median of 30 across 145 interventional studies indexed under Neurofibromatosis 1.
Browse Neurofibromatosis 1 studies →The Hospital for Sick Children is the lead sponsor of 577 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Virtual or in-person weekly group sessions (\~50 minutes each) over a 13-week period.
Behavioral: Unstuck and On Target!
Waitlist control group. The same intervention program will be administered for this group once they are off the waitlist.
Behavioral: Unstuck and On Target!
Unstuck and On Target! (UOT) is an evidence-based executive functioning (EF) intervention that places an emphasis on "real world" application of acquired skills. Participants can participate in-person or online, and either an in-person or online group format will then be offered. As such, those who are not able to participate in the current iteration of the group will be placed on a waitlist. Screened participants who are willing to participate in the current format will be randomized into those receiving treatment immediately or in 6 months (waitlist control group). Both parent and youth sessions will be 50- to 60-minutes long and will be administered in-person or over Zoom. Sessions will also assess participant engagement in the program and learning of program content using "Unstuck Vocabulary" tasks. These measure participant knowledge and use of words used in the program to describe specific principles or concepts. Fidelity will also be measured.
Developing and assessing preliminary feasibility and acceptability of an intervention tailored to support NF1 patients
Protocol feasibility will be assessed by consent/recruitment, attendance, and completion rates. Intervention group participants will rate their satisfaction with aspects of the program on a brief survey using 5-point Likert scales (ranging from "dissatisfied" to "extremely satisfied"). Semi-structured interviews administered to participants post-intervention will assess program feasibility and acceptability.
Time frame: From enrollment to the end of treatment at 13 weeks
Assessing the intervention's impact on parent stress
Parental stress will be assessed using a 5-point Likert scale, via the Parenting Stress Index (PSI-4), ranging from "Strongly Agree" to "Strongly Disagree", to measure the magnitude of stress in parent-child relationships.
Time frame: From enrollment to the end of treatment at 13 weeks
Assessing the intervention's impact on children's executive functioning
Executive Functioning will be assessed using a 3-point Likert scale ("Never", "Sometimes", "Often"), via the Behavior Rating Inventory of Executive Function (BRIEF-2), to measure everyday executive functioning in children and adolescents.
Time frame: From enrollment to the end of treatment at 13 weeks
Assessing the intervention's impact on children's self-determination
Child's self-determination will be assessed using a 5-point Likert scale (ranging from "Never" to "Always"), via the AIR Self-Determination questionnaire.
Time frame: From enrollment to the end of treatment at 13 weeks
Assessing the intervention's impact on children's autonomy
Child autonomy will be assessed using a 4-point Likert scale (ranging from "Never" to "Almost Always"), via the Adaptive Behavior Assessment System (ABAS-3) questionnaire, which measures everyday functional skills and adaptive behavior.
Time frame: From enrollment to the end of treatment at 13 weeks
Assessing the intervention's impact on children's quality of life
Quality of life will be assessed using a 5-point Likert scale via the World Health Organization - Brief (WHOQOL-BREF) questionnaire.
Time frame: From enrollment to the end of treatment at 13 weeks
Assessing the intervention's impact on children's mental health
Child's mental health will be assessed using a 5-point Likert scale (ranging from "Never" to "Almost Always"), via the PROMIS (Patient-Reported Outcomes Measurement Information System) depression and anxiety questionnaires.
Time frame: From enrollment to the end of treatment at 13 weeks
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Start is estimated for Sep 2026; primary completion for Dec 2028, 27 months later.
Of 28 interventional studies with no phase under Neurofibromatosis 1, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 27 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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