Attention Deficit Disorder With Hyperactivity (ADHD)NCT06703242
Pilot Study on a Health Promotion Intervention for Ultra-Orthodox Mothers of Children With ADHD
A study testing Health promotion for mothers of children with ADHD in the ultra-orthodox community in people with Attention Deficit Disorder With Hyperactivity (ADHD), run by Adina Maeir at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity (ADHD)
- What is being tested?
- Health promotion for mothers of children with ADHD in the ultra-orthodox community
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Nov 2024to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Child medical diagnosis other than ADHD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hebrew University
Jerusalem, 9190501
Jennifer Budman, PhD, 972503422600, jennifer.budman@mail.huji.ac.il
Adina Maeir, Professor, 972503422600, adina.maeir@mail.huji.ac.il
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Health promotion for mothers of children with ADHD in the ultra-orthodox community
- Keywords
- Mothering a child with ADHD, Maternal psychological health, Ultra-orthodox
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health promotion for mothers of children with ADHD in the ultra-orthodox communityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Health promotion intervention group | Other | A one time six-session weekly intervention group for mothers of children with ADHD in the ultra-orthodox community. Receives: Other: Health promotion for mothers of children with ADHD in the ultra-orthodox community |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Ever heard of ADHD (no =0; yes= 1)
- Recency of information (0= heard months to years ago or never; 1= heard days to weeks ago)
- Self-rated knowledge amount (0= knows little to nothing; 1 =knows some or a lot)
- Number of information sources used (0= none or one; 1 = two or more sources cited)
- 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: from enrollment until the end of the six week sessions of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start24 Nov 2024
- Primary completionJan 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With Hyperactivity (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mothers in the control group will receive the intervention right after the completion of the intervention group.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adina Maeir
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Sponsor-investigator, Adina Maeir, Hebrew University of Jerusalem
- Investigators
- Adina Maeir, PhD, Principal investigator, Hebrew University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703242
- Sponsor's protocol ID
- 30012024
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol Statistical analysis plan Informed consent form All IPD that are part of the results section in a publication
Publications
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.
PubMed 38424536Budman 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.
PubMed 36922732Budman 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.
PubMed 36361375Bourke-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.
PubMed 25201148Bussing 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.
PubMed 23174470Kellison 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.
PubMed 20580842Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.
PubMed 649936
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-randomized Controlled Pilot Study of a Health Promotion Program for Mothers of Children in the Ultra-orthodox Community: Examining Feasibility
- ClinicalTrials.gov ID
- NCT06703242
- Acronym / sponsor ID
- 30012024
- Keywords
- Mothering a child with ADHD, Maternal psychological health, Ultra-orthodox
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Adina MaeirUniversity, hospital or other
- Collaborators
- Monash University
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mothers in the control group will receive the intervention right after the completion of the intervention group.
| Arm | Type | Receives |
|---|---|---|
| Health promotion intervention group | Other | Other: Health promotion for mothers of children with ADHD in the ultra-orthodox communityA one time six-session weekly intervention group for mothers of children with ADHD in the ultra-orthodox community. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Child medical diagnosis other than ADHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health promotion for mothers of children with ADHD in the ultra-orthodox communityThe 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. | Other | Health promotion intervention group |
Primary outcome
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)
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
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background: PubMed 38424536Budman 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.
- Background: PubMed 36922732Budman 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.
- Background: PubMed 36361375Budman 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.
- Background: PubMed 25201148Bourke-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.
- Background: PubMed 23174470Bussing 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.
- Background: PubMed 20580842Kellison 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.
- Background: PubMed 649936Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.
- Individual participant dataSharing planned: Yes. Study protocol Statistical analysis plan Informed consent form All IPD that are part of the results section in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adina Maeir, PhD principal investigator
Hebrew University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health promotion for mothers of children with ADHD in the ultra-orthodox community in people with Attention Deficit Disorder With Hyperactivity (ADHD), run by Adina Maeir at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Budman, PhD (972 503422600, jennifer.budman@mail.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06703242, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.