NCT06703242

Brief Summary

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:

  1. 1.Is the intervention feasible for mothers to participate?
  2. 2.Does the intervention improve maternal knowledge about ADHD and reduce stigma?
  3. 3.Does it help reduce maternal stress and enhance self-care practices?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

November 24, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

November 21, 2024

Last Update Submit

November 24, 2024

Conditions

Keywords

Mothering a child with ADHDMaternal psychological healthUltra-orthodox

Outcome Measures

Primary Outcomes (4)

  • Change in maternal ADHD Knowledge as measured by the ADHD Knowledge Questionnaire (Bussing, 2014)

    The summary knowledge score is composed of the sum of 5 variables: 1. Ever heard of ADHD (no =0; yes= 1) 2. Recency of information (0= heard months to years ago or never; 1= heard days to weeks ago) 3. Self-rated knowledge amount (0= knows little to nothing; 1 =knows some or a lot) 4. Number of information sources used (0= none or one; 1 = two or more sources cited) 5. Attribution of ADHD to sugar in the diet (0= probably or definitely true; 1 =probably or definitely false). 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

    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

    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

    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

Study Arms (1)

Health promotion intervention group

OTHER

A one time six-session weekly intervention group for mothers of children with ADHD in the ultra-orthodox community.

Other: Health promotion for mothers of children with ADHD in the ultra-orthodox community

Interventions

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.

Health promotion intervention group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Child medical diagnosis other than ADHD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebrew University

Jerusalem, 9190501, Israel

RECRUITING

Related Publications (7)

  • 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.

    PMID: 38424536BACKGROUND
  • 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.

    PMID: 36922732BACKGROUND
  • 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.

    PMID: 36361375BACKGROUND
  • 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.

    PMID: 25201148BACKGROUND
  • 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.

    PMID: 23174470BACKGROUND
  • 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.

    PMID: 20580842BACKGROUND
  • Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.

    PMID: 649936BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Adina Maeir, PhD

    Hebrew University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Mothers in the control group will receive the intervention right after the completion of the intervention group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 21, 2024

First Posted

November 25, 2024

Study Start

November 24, 2024

Primary Completion

January 1, 2025

Study Completion

May 1, 2025

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Study protocol Statistical analysis plan Informed consent form All IPD that are part of the results section in a publication

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The study protocol and informed consent form are already available. The statistical analysis plan will be available within 6 months of publication.
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.

Locations