Cognitive Intervention for Children and Adolescents With NF1
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorThe Hospital for Sick Children
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Receive subject-informed consent;
Youth with a diagnosis of NF1 and their parents;
Youth aged 8-17 years old (inclusive) and their parents
Disqualifiers
Conditions that significantly affect cognition (e.g., intellectual disability diagnosis, active psychosis), hearing loss or vision problems precluding participation in group
Non-English speaking
Trial design
Design model
Single group
Treatments tested in this trial
Unstuck and On Target!
BehavioralUnstuck 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: UOT programExperimental treatment 1 intervention
Group B: UOT waitlist control groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: