Pilot Study on a Health Promotion Intervention for Ultra-Orthodox Mothers of Children With ADHD

November 24, 2024 updated by: Adina Maeir

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:

  1. Is the intervention feasible for mothers to participate?
  2. Does the intervention improve maternal knowledge about ADHD and reduce stigma?
  3. 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

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

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  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
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

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Adina Maeir, PhD, Hebrew University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Actual)

November 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 24, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

The study protocol and informed consent form are already available. The statistical analysis plan will be available within 6 months of publication.

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

No

Studies a U.S. FDA-regulated device product

No

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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