[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659866":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":40,"interventions":51,"overallOfficials":57,"centralContacts":61,"locations":32,"responsibleParty":68,"collaborators":32,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":32,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":32,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":108,"whyStopped":32,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":32},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Developing and assessing preliminary feasibility and acceptability of an intervention tailored to support NF1 patients","Protocol feasibility will be assessed by consent\u002Frecruitment, 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.","From enrollment to the end of treatment at 13 weeks",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"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.",{"measure":27,"description":28,"timeFrame":12},"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.",{"measure":30,"description":31,"timeFrame":12},"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.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"RANDOMIZED","SINGLE_GROUP","* The intervention will be administered, virtually or in-person, by a trained graduate student or postdoctoral fellow in Clinical (Neuro)Psychology, under the supervision of a Clinical Neuropsychologist, to a group of 6-8 NF1 patients at a time (ages 8-17) and their parents.\n* Participants will complete pre- and post-treatment questionnaires, follow-up questionnaires (6 months post-intervention), as well as a post-treatment interview (shortly after the end of the intervention) to assess social communication skills and parent executive functioning skills, as well as intervention impact on parent stress and children's EF, self-determination, autonomy, quality of life, and mental health.\n* This will be a waitlist control design study. Participants in the waitlist control group will have an additional data collection time point, 6 months before they begin the intervention. At post-treatment, participants will rate their satisfaction with the program.","TREATMENT",{"masking":39,"maskingDescription":32,"whoMasked":32},"NONE",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"UOT program","EXPERIMENTAL","Virtual or in-person weekly group sessions (\\~50 minutes each) over a 13-week period.",[46],"Behavioral: Unstuck and On Target!",{"label":48,"type":43,"description":49,"interventionNames":50},"UOT waitlist control group","Waitlist control group. The same intervention program will be administered for this group once they are off the waitlist.",[46],[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":32},"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.\n\nParticipants 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).\n\nBoth parent and youth sessions will be 50- to 60-minutes long and will be administered in-person or over Zoom.\n\nSessions 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.",[42,48],[58],{"name":59,"affiliation":5,"role":60},"Busi Zapparoli, Ph.D., C.Psych.","PRINCIPAL_INVESTIGATOR",[62],{"name":63,"role":64,"phone":65,"phoneExt":66,"email":67},"Tima Al-Rubeye, B.Sc.","CONTACT","416-813-7654","415468","tima.al-rubeye@sickkids.ca",{"type":60,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Busi Zapparoli","Clinical Neuropsychologist, Associate Scientist-Track Investigator","100659866","cognitive-intervention-for-children-and-adolescents-with-nf1-100659866",false,"NCT07869914","Cognitive Intervention for Children and Adolescents With NF1","Feasibility Pilot of a Cognitive Intervention for Children and Adolescents With Neurofibromatosis, Type 1","Inclusion Criteria:\n\n* Receive subject-informed consent;\n* Youth with a diagnosis of NF1 and their parents;\n* Youth aged 8-17 years old (inclusive) and their parents\n\nExclusion Criteria:\n\n* Conditions that significantly affect cognition (e.g., intellectual disability diagnosis, active psychosis), hearing loss or vision problems precluding participation in group\n* Non-English speaking","ALL","8 Years","17 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"NA","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.",[89,90,91],"Neurofibromatosis 1 (NF1)","Executive Function (Cognition)","Cognitive Intervention",[93,94,95,96,97,98,99,100,101,102,103,104,105,106,107],"NF1","cognitive intervention","psychological intervention","executive functioning","quality of life","children and adolescents with NF1","youth with NF1","parental stress","problem-solving skills","mental health","unstuck and on target","UOT","EF","self-determination","autonomy","NOT_YET_RECRUITING","2026-10-05",{"date":111,"type":112},"2026-10-13","ACTUAL",{"date":114,"type":83},"2026-09-28",{"date":116,"type":83},"2029-06",{"name":5,"class":6}]