Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152913
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-11-15
Brief Title:
HANDS-ON a Personalized Brief and Intensive Exposure-based Intervention for Youth With Persistent Anxiety or OCD
Sponsor:
Accare
Organization:
Accare
Study Overview
Official Title:
All Hands on Deck Youth Therapists Parents and School Professionals Joining Forces in a Personalized Brief and Intensive Exposure-based Intervention for Youth With Persistent Anxiety or Obsessive Compulsive Disorder
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A substantial part of childrenadolescents with anxiety or obsessive-compulsive disorder ADOCD do not profit substantially from first-choice treatment ie cognitive behavioral therapy CBT For them no evidence-based treatment is available The aim of this project is to evaluate and optimize a newly-developed personalized short and intensive exposure-based intervention HANDS-ON for treatment non-responders Collaboration with children parents and teachers guided exposure in a childs natural environment personalized treatment goals and meaningmotivation are central principles
Methods A multiple baseline single-case experimental design is used qualitative and quantitative Participants are childrenadolescents 10-18 years N12 with an ADOCD diagnosis for whom standard CBT did not lead to sufficient improvement Children and parents are asked to complete questionnaires before during and after the treatment Children parents and school professionals will be asked to participate in qualitative interviews to evaluate their experiences with the HANDS-ON treatment program
Methods A multiple baseline single-case experimental design is used qualitative and quantitative Participants are childrenadolescents 10-18 years N12 with an ADOCD diagnosis for whom standard CBT did not lead to sufficient improvement Children and parents are asked to complete questionnaires before during and after the treatment Children parents and school professionals will be asked to participate in qualitative interviews to evaluate their experiences with the HANDS-ON treatment program
Detailed Description:
BACKGROUND Nearly half of children and adolescents with anxiety or obsessive-compulsive disorders do not reach remission after first-choice treatment cognitive behavioral therapy CBT and 10-25 discontinue treatment prematurely For them no evidence-based treatment is available They may have severe symptoms with a huge impact on daily functioning quality of life family life and society These youth are at risk of developmental delays among others due to school refusal They often receive time-consuming expensive treatment without evidence of effectiveness
OBJECTIVES The aim of this project is to evaluate and optimize a newly-developed treatment for this group This treatment HANDS-ON is innovative short and intensive based on scientific research and insights from clinical practice Collaboration with children parents and teachers guided exposure in a childs natural environment personalized treatment goals and meaningmotivation are central principles
Our research questions are
1 Quantitative What are within-subjects effects of HANDS-ON on personalized goal attainment anxietyOCD severity and functioning in youth with persistent ADOCD
2 Qualitative What are the experiences facilitators and barriers of HANDS-ON from a child parent school professional and therapist perspective
The results of this study will be used to improve HANDS-ON with the aim to further investigate its effectiveness in a randomised controlled trial as a next step
METHOD Participants are 12 childrenadolescents with persistent anxiety- or obsessive-compulsive symptoms treatment non-responders Inclusion criteria a age 10-18 years b diagnosis of anxiety disorder or obsessive-compulsive disorder DSM-5 c non-response to previous CBT CBT with insufficient effect Co-morbid diagnoses are allowed except for those interfering with safety or warranting immediate treatment eg acute suicidality or psychosis
Design multiple baseline single-case experimental design Participants will be randomised to one of four baseline periods 25-4 weeks followed by HANDS-ON 9 weeks and follow-up 4 weeks Progress on personalized treatment goals primary outcome and on symptoms impairment and avoidance secondary outcome will be measured daily Other outcomes will be measured at baseline T0 start HANDS-ON T1 subset after HANDS-ON T2 and at follow-up T3 Semi-structured interviews qualitative evaluation will be conducted with the youth their parents school professionals and therapists post-treatment
Analyses The primary outcome will be analysed using randomisation tests and combined using meta-analytic analyses Descriptive analyses and tests for repeated measures will be used to analyse secondary outcomes Qualitative interviews will be recorded and analysed using thematic text analysis
OBJECTIVES The aim of this project is to evaluate and optimize a newly-developed treatment for this group This treatment HANDS-ON is innovative short and intensive based on scientific research and insights from clinical practice Collaboration with children parents and teachers guided exposure in a childs natural environment personalized treatment goals and meaningmotivation are central principles
Our research questions are
1 Quantitative What are within-subjects effects of HANDS-ON on personalized goal attainment anxietyOCD severity and functioning in youth with persistent ADOCD
2 Qualitative What are the experiences facilitators and barriers of HANDS-ON from a child parent school professional and therapist perspective
The results of this study will be used to improve HANDS-ON with the aim to further investigate its effectiveness in a randomised controlled trial as a next step
METHOD Participants are 12 childrenadolescents with persistent anxiety- or obsessive-compulsive symptoms treatment non-responders Inclusion criteria a age 10-18 years b diagnosis of anxiety disorder or obsessive-compulsive disorder DSM-5 c non-response to previous CBT CBT with insufficient effect Co-morbid diagnoses are allowed except for those interfering with safety or warranting immediate treatment eg acute suicidality or psychosis
Design multiple baseline single-case experimental design Participants will be randomised to one of four baseline periods 25-4 weeks followed by HANDS-ON 9 weeks and follow-up 4 weeks Progress on personalized treatment goals primary outcome and on symptoms impairment and avoidance secondary outcome will be measured daily Other outcomes will be measured at baseline T0 start HANDS-ON T1 subset after HANDS-ON T2 and at follow-up T3 Semi-structured interviews qualitative evaluation will be conducted with the youth their parents school professionals and therapists post-treatment
Analyses The primary outcome will be analysed using randomisation tests and combined using meta-analytic analyses Descriptive analyses and tests for repeated measures will be used to analyse secondary outcomes Qualitative interviews will be recorded and analysed using thematic text analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None