- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06703242
Pilot Study on a Health Promotion Intervention for Ultra-Orthodox Mothers of Children With ADHD
Non-randomized Controlled Pilot Study of a Health Promotion Program for Mothers of Children in the Ultra-orthodox Community: Examining Feasibility
The goal of this study is to evaluate the feasibility and effectiveness of a health promotion intervention for Ultra-Orthodox Jewish mothers of children with ADHD.
This study will examine the impact of a culturally tailored group-based intervention aimed at reducing stress, enhancing health, and improving the well-being of mothers.
The main questions this study aims to answer are:
- Is the intervention feasible for mothers to participate?
- Does the intervention improve maternal knowledge about ADHD and reduce stigma?
- Does it help reduce maternal stress and enhance self-care practices?
Participants include:
Mothers: Ultra-Orthodox Jewish mothers with a child (ages 6-12) diagnosed with ADHD and no other major health conditions in the family (other than ADHD).
Educators: School educators with at least 5 years of experience teaching children with ADHD in the Ultra-Orthodox community.
What participation involves:
Mothers will attend six weekly teletherapy group sessions, with 6-8 mothers per group. They will complete questionnaires before and after the intervention (approximately 30 minutes each) and participate in a 90-minute remote focus group to provide feedback on the program.
Educators will attend a single teletherapy group session (90 minutes) during the program (session 5) and participate in a 90-minute remote interview to provide feedback on the program.
Study Overview
Status
Intervention / Treatment
Detailed Description
After providing informed consent, mothers will complete questionnaires which will take approximately 30 minutes before beginning the program. Mothers will then be assigned non-randomly to the intervention or control group. Mothers assigned to the control group will receive the intervention after the completion of the first intervention group (delayed).
The six sessions of the intervention will be teletherapy and each session will be one and a half hours in length. Each group will consist of 6-8 mothers per group.
Inclusion criteria included mothers who identify as ultra-orthodox Jewish, have a child between the ages of 6-12 years old who have been diagnosed with ADHD by a licensed medical professional, and who do not have any other medical diagnosis.
The topics discussed in the intervention will include: Awareness/knowledge regarding ADHD and its biological origins, Identifying resources and optimal treatment for ADHD for the child and the mother, Strategies for child ADHD management in the school, and the legitimacy and importance of maternal self-care.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer Budman, PhD
- Phone Number: 972 503422600
- Email: jennifer.budman@mail.huji.ac.il
Study Locations
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-
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Jerusalem, Israel, 9190501
- Recruiting
- Hebrew University
-
Contact:
- Jennifer Budman, PhD
- Phone Number: 972503422600
- Email: jennifer.budman@mail.huji.ac.il
-
Contact:
- Adina Maeir, Professor
- Phone Number: 972503422600
- Email: adina.maeir@mail.huji.ac.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- mothers of children with ADHD aged 6- 12 years old
- Mothers who identify as ultra-orthodox Jews
- Child diagnosis was by a licensed medical professional
Exclusion Criteria:
- Child medical diagnosis other than ADHD
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Health promotion intervention group
A one time six-session weekly intervention group for mothers of children with ADHD in the ultra-orthodox community.
|
The intervention will consist of 3 modules with six sessions.
Mothers will gain knowledge in topics related to understanding the ADHD health condition and its biological origins, optimal and recommended treatment options, school management techniques, and the importance of taking care of their own health.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in maternal ADHD Knowledge as measured by the ADHD Knowledge Questionnaire (Bussing, 2014)
Time Frame: from enrollment until the end of the six week sessions of the intervention
|
The summary knowledge score is composed of the sum of 5 variables:
Knowledge scores can range from 0 to 5 ('0' indicating the least amount of knowledge), and were normally distributed (mean =2.6, SD =1.6, median =3) |
from enrollment until the end of the six week sessions of the intervention
|
|
Change in maternal ADHD stigma as measured by the ADHD Stigma Scale
Time Frame: from enrollment until the end of the six week sessions of the intervention
|
The questions ask about some of the experiences, feelings, and opinions people with ADHD might have and how they are treated. Each item is rated on a 4-point Likert scale (1=strongly disagree; 2=disagree; 3-agree; 4=strongly agree), with higher scores indicating higher stigma perceptions. The overall stigma score is composed of the sum of all 26 items |
from enrollment until the end of the six week sessions of the intervention
|
|
Change in maternal stress as measured by the Parental Stress Items
Time Frame: from enrollment until the end of the six week sessions of the intervention
|
Parenting Stress Items measures parental stress, by asking parents to consider how "tense" or "frustrated" they feel about parenting their children.
Includes 11 items scored on a four-point scale (1¼not at all to 4¼very much so), yielding scores ranging from 11-44, with higher scores indicating greater levels of parenting stress.
|
from enrollment until the end of the six week sessions of the intervention
|
|
Change in maternal participation in health promoting activities as measured by the Health Promoting Activities Scale
Time Frame: from enrollment until the end of the six week sessions of the intervention
|
Health Promoting Activities Scale (HPAS) is an eight-item measure that assesses frequency of participation in social, emotional, physical, and spiritual leisure activities on a seven-point scale (1=never to 7=once or more every day).
Scores range from 8 to 56, with higher scores indicating more frequent participation
|
from enrollment until the end of the six week sessions of the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Adina Maeir, PhD, Hebrew University
Publications and helpful links
General Publications
- Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.
- Budman JR, Maeir A. Development of a psychological health promotion intervention for ultra-orthodox Jewish mothers of children with ADHD using the intervention mapping protocol. BMC Public Health. 2024 Feb 29;24(1):645. doi: 10.1186/s12889-024-18126-4.
- Budman JR, Fogel-Grinvald H, Maeir A. Psychological Health and Quality of Life among Ultra-orthodox Mothers of Children with Attention Deficit Hyperactivity Disorder: Impact of Occupational Experiences. Phys Occup Ther Pediatr. 2023;43(6):697-712. doi: 10.1080/01942638.2023.2188077. Epub 2023 Mar 15.
- Budman J, Maeir A. Mothering a Child with ADHD in the Ultra-Orthodox Community. Int J Environ Res Public Health. 2022 Nov 4;19(21):14483. doi: 10.3390/ijerph192114483.
- Bourke-Taylor H, Lalor A, Farnworth L, Pallant JF. Further validation of the Health Promoting Activities Scale with mothers of typically developing children. Aust Occup Ther J. 2014 Oct;61(5):308-15. doi: 10.1111/1440-1630.12137. Epub 2014 Sep 9.
- Bussing R, Zima BT, Mason DM, Meyer JM, White K, Garvan CW. ADHD knowledge, perceptions, and information sources: perspectives from a community sample of adolescents and their parents. J Adolesc Health. 2012 Dec;51(6):593-600. doi: 10.1016/j.jadohealth.2012.03.004. Epub 2012 Apr 17.
- Kellison I, Bussing R, Bell L, Garvan C. Assessment of stigma associated with attention-deficit hyperactivity disorder: psychometric evaluation of the ADHD stigma questionnaire. Psychiatry Res. 2010 Jul 30;178(2):363-9. doi: 10.1016/j.psychres.2009.04.022. Epub 2010 May 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30012024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
De-identified individual participant data (IPD), including questionnaire and statistical analysis results, will be shared upon reasonable request for research purposes. Access will be granted to qualified researchers affiliated with academic, healthcare, or research institutions for analyses advancing knowledge of ADHD interventions, maternal health, or culturally tailored health promotion programs.
Requests must be submitted in writing to the principal investigator (PI) and include:
A summary of the request's purpose. Institutional affiliation and researcher qualifications. A data use agreement ensuring confidentiality and ethical compliance. The PI and a review panel will evaluate requests based on scientific validity and alignment with study goals. Approved data will be shared via secure methods, such as encrypted file-sharing platforms, in compliance with privacy regulations. Data will be available 6 months after publication and remain accessible for 2 years.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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