Attention Deficit Disorder With HyperactivityADHDNCT04010851
The Effects of a Peer Co-led Educational Programme for Parents of Children With ADHD
A study testing Peer co-led educational group and Comparator treatment as usual in people with Attention Deficit Disorder With Hyperactivity, run by Norwegian University of Science and Technology.
Trial summary
ADHD is associated with a substantial burden on families, and systems pertaining to health, social care, and criminal justice, and there is a need for more knowledge of the effects of non-pharmacological interventions. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Peer co-led educational group and Comparator treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents of children aged 6 - 12 with a formal diagnosis of ADHD, following a standardised assessment.
Who cannot join
- Participants already taking part in research on a parenting intervention will also be ineligible to participate.
- Families attending other parenting groups
About this study
Official title: The Effects of a Peer Co-led Educational Programme for Parents of Children With ADHD: A Feasibility Randomized Controlled Trial
ADHD is associated with a substantial burden on families, and systems pertaining to health, social care, and criminal justice, and there is a need for more knowledge of the effects of non-pharmacological interventions. Educational and parental activation interventions may improve ADHD symptoms, and may enhance parent activation. Although the results of these studies are promising, few interventions have been carried out in collaboration with user representatives, which is required by Norwegian legislation. As such, there is a need for clinical studies that document the effects of educational group interventions based on user involvement that seeks to improve parental activation. Furthermore, it is not clear which type of educational intervention that should be offered, and which aspects of parenting behaviour to focus on. There is a lack of studies investigating whether adding an intervention designed specifically for families of children with ADHD will be more effective than treatment as usual (TAU). The purpose of the present study is to determine the feasibility and expected size of a substantive randomized controlled trial comparing an ADHD peer co-led educational programme added to TAU.
Read the detailed description
The primary objective of this trial is to evaluate the acceptability and feasibility of the intervention, to assure that procedures are adequate for a subsequent full size randomized controlled trial (RCT), and to determine the likely size of the trial comparing an ADHD specific parenting peer co-led intervention for parents of children with ADHD symptoms.
Specific objectives are:
(I) investigate whether parents of children recently diagnosed with ADHD are willing to be randomized to the intervention, (II) whether sufficient numbers of families can be recruited and retained such that a full-scale RCT is likely to be feasible, (III) whether research procedures and efficacy measures are feasible and acceptable to participating families and the outpatient clinics, and (IV) whether families participating in the intervention are satisfied with the intervention.
This feasibility study is not designed to detect a treatment effect, therefore a maximum of 50 parents will be recruited. The measurements will be taken in the children (at baseline and 3 months) and parents (at baseline, two weeks, pre-post intervention and 3 months follow-up) to determine the feasibility and acceptability. These measures are chosen because they address key components of the intervention (activation, quality of life and psychological well-being). Multiple measures of similar constructs will be administered where possible (e.g., psychological well-being and quality of life) to determine which measure to include in the definitive trial according to feasibility, acceptability, and sensitivity.
Feasibility assessments:
- Feasibility of recruitment.
- Acceptability of randomization and procedures will be determined by measuring loss to follow-up (post-test and 3-month follow-up), and reasons for withdrawal will be used collected.
- Acceptability of the intervention will be determined based on the number of sessions attended by participants in the peer co-led education. We will also reported on satisfaction with the program.
- Feasibility of quantitative measures will be deemed acceptable if no questionnaires are missing in full in more than 25% of the participants and if reliability was higher than 0.70.
- Follow-up response rates (post-intervention and 3 months follow-ups).
- Being tested
- Peer co-led educational group, Comparator treatment as usual
- Keywords
- Parental activation, Peer co-led education
- 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.
Peer co-led educational groupBehavioural
The intervention is delivered in a group format, which takes the form of a full day's training, focusing on ADHD diagnosis, its treatment, how to cope with the challenges related to living with ADHD, as well as coping with challenges of parenting a child with chronic health conditions. After this one day-intervention, the participants can continue in self-help groups, which meet once a week for a 2-hour evening session. User representatives lead these weekly self-help groups, which do not require user-fees and aim to offer practical tools, support and information to increase the parent's skills, knowledge and confidence. Participants are encouraged to adopt an active role in order to achieve a positive parent/provider partnership.
Comparator treatment as usualBehavioural
Control group will receive treatment as usual, including different treatment options that can help alleviate the symptoms of ADHD and arm families with the tools needed to better handle problem behaviors when they arise. These interventions include: medication, psychotherapy, or a combination of these two approaches.
| Study group | Role | What they receive |
|---|---|---|
| Peer co-led educational group | Experimental | The intervention delivered in a group format is added to treatment as usual. After the parents participate in the one day-intervention, they can continue in self-help groups, which meet once a week for a 2-hour evening session. User representatives lead these weekly self-help groups, which do not require user-fees and aim to offer practical tools, support and information to increase the parent's skills, knowledge and confidence. Receives: Behavioral: Peer co-led educational group |
| Control group | Other | The control goup will receive treatment as usual. Receives: Behavioral: Comparator treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Feasibility of recruitment will be assessed by determining the recruitment rate, by monitoring patient screening and subsequent agreement to participate.
Measured: Over a two year study period
Satisfaction with the intervention
Parent satisfaction will be measured by means of the client satisfaction Questionnaire, CSQ-3 as it applies to the group-based educational programme. The scale comprises three items measured on a scale from 1 (not satisfied) to 4 (very satisfied).
Measured: From baseline to 12- and 52-weeks follow-up
Parental activation
Parental activation will be measure with the P-PAM-13. The 13-items P-PAM has four possible response options ranging from (1) strongly disagree, to (4) strongly agree, and an additional 'not applicable' option.
Measured: From baseline to 12- and 52-weeks follow-up
Secondary outcomes (8)
Parental well-being
Parental well-being will be measured by the WHO-5 Well-being Index. The questionnaire has five items rated on a six-point scale from 0 (all the time) to 5 (at no time); this items are transformed into 0-100 scales (high scores indicate a better well-being).
Measured: From baseline to 12- and 52-weeks follow-up
Parental quality of life
Parental quality of life will be measured by the 10- items Multicultural Quality of Life Index (MQLI) which cover key aspects of the concept, from physical well-being to spiritual fulfilment. The MQLI questionnaire has ten items.
Measured: From baseline to 12- and 52-weeks follow-up
Shared decision making
It will be assessed using a modified version of the Control Preferences Scale to provide information about the parent's preferred role in involvement.
Measured: From baseline to 12- and 52-weeks follow-up
Parental involvement in treatment decision
Parent involvement will be assessed using a modified version of the CollaboRATE scale
Measured: From baseline to 12- and 52-weeks follow-up
Beliefs about medicines
To investigate the beliefs about medicines we will use the Beliefs about Medicines Questionnaire (BMQ).
Measured: From baseline to 12- and 52-weeks follow-up
Adherence
To investigate medication adherence using the Medication Adherence Rating Scale 5 items.
Measured: From baseline to 12- and 52-weeks follow-up
ADHD Scale Parent Version
The SNAP-IV 18-Item will be use to evaluate ADHD, the SNAP-IV 18-Item Scale Parent Version is an abbreviated version of the Swanson, Nolan, and Pelham (SNAP). The questionnaire includes items for the two subsets of symptoms, inattention (items 1-9) and hyperactivity/impulsivity (items 10-18), from the DSM-IV criteria for ADHD. The scores in each of the two subsets are added together. SNAP-IV is used to measure ADHD symptoms and behavioral problems in school-aged children. Symptom severity is rated on a 4-point scale.
Measured: From baseline to 12- and 52-weeks follow-up
Level of functioning of children in Child
The C-GAS will be used to assess the overall level of functioning of children. The C-GAS is a numeric scale ranging from 1 to 100 used to assess the overall level of functioning of children in Child and Adolescent Mental Health Services, with high scores indicating better functioning.
Measured: From baseline to 12- and 52-weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study startMar 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Why it stopped: to much uncertainty about possibilities for recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention is delivered in a group format, which takes the form of a full day's training, focusing on ADHD diagnosis, its treatment, how to cope with the challenges related to living with ADHD, as well as coping with challenges of parenting a child with chronic health conditions. After this one day-intervention, the participants can continue in self-help groups, which meet once a week for a 2-hour evening session. User representatives lead these weekly self-help groups, which do not require user-fees and aim to offer practical tools, support and information to increase the parent's skills, knowledge and confidence. Participants are encouraged to adopt an active role in order to achieve a positive parent/provider partnership.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Molde University College
- Responsible party
- Sponsor
- Investigators
- Ingunn P. Mundal, PhD, Principal investigator, Molde University CollegeMariela Loreto Lara Cabrera, PhD, Principal investigator, St Olavs Hospital, Department of research and development AFFU, and NTNURolf W. Gråwe, Phd prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010851
- Sponsor's protocol ID
- 2018/1196/REK Mid Norway
- Acronym
- ADHD
- Status last verified
- Jan 2022
- First submitted
- 28 Jun 2019
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We anticipate that anonymised trial data may be shared with other researchers to enable international prospective meta-analyses.
Publications
Mundal I, Grawe RW, Hafstad H, De Las Cuevas C, Lara-Cabrera ML. Effects of a peer co-facilitated educational programme for parents of children with ADHD: a feasibility randomised controlled trial protocol. BMJ Open. 2020 Dec 2;10(12):e039852. doi: 10.1136/bmjopen-2020-039852.
PubMed 33268416
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Peer Co-led Educational Programme for Parents of Children With ADHD: A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04010851
- Acronym / sponsor ID
- ADHD / 2018/1196/REK Mid Norway
- Keywords
- Parental activation, Peer co-led education
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: to much uncertainty about possibilities for recruiting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Molde University College
- Study start
- Mar 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 8 Jul 2019 (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.
ADHD is associated with a substantial burden on families, and systems pertaining to health, social care, and criminal justice, and there is a need for more knowledge of the effects of non-pharmacological interventions. Educational and parental activation interventions may improve ADHD symptoms, and may enhance parent activation. Although the results of these studies are promising, few interventions have been carried out in collaboration with user representatives, which is required by Norwegian legislation. As such, there is a need for clinical studies that document the effects of educational group interventions based on user involvement that seeks to improve parental activation. Furthermore, it is not clear which type of educational intervention that should be offered, and which aspects of parenting behaviour to focus on. There is a lack of studies investigating whether adding an intervention designed specifically for families of children with ADHD will be more effective than treatment as usual (TAU). The purpose of the present study is to determine the feasibility and expected size of a substantive randomized controlled trial comparing an ADHD peer co-led educational programme added to TAU.
Detailed description
The primary objective of this trial is to evaluate the acceptability and feasibility of the intervention, to assure that procedures are adequate for a subsequent full size randomized controlled trial (RCT), and to determine the likely size of the trial comparing an ADHD specific parenting peer co-led intervention for parents of children with ADHD symptoms.
Specific objectives are:
(I) investigate whether parents of children recently diagnosed with ADHD are willing to be randomized to the intervention, (II) whether sufficient numbers of families can be recruited and retained such that a full-scale RCT is likely to be feasible, (III) whether research procedures and efficacy measures are feasible and acceptable to participating families and the outpatient clinics, and (IV) whether families participating in the intervention are satisfied with the intervention.
This feasibility study is not designed to detect a treatment effect, therefore a maximum of 50 parents will be recruited. The measurements will be taken in the children (at baseline and 3 months) and parents (at baseline, two weeks, pre-post intervention and 3 months follow-up) to determine the feasibility and acceptability. These measures are chosen because they address key components of the intervention (activation, quality of life and psychological well-being). Multiple measures of similar constructs will be administered where possible (e.g., psychological well-being and quality of life) to determine which measure to include in the definitive trial according to feasibility, acceptability, and sensitivity.
Feasibility assessments:
- Feasibility of recruitment.
- Acceptability of randomization and procedures will be determined by measuring loss to follow-up (post-test and 3-month follow-up), and reasons for withdrawal will be used collected.
- Acceptability of the intervention will be determined based on the number of sessions attended by participants in the peer co-led education. We will also reported on satisfaction with the program.
- Feasibility of quantitative measures will be deemed acceptable if no questionnaires are missing in full in more than 25% of the participants and if reliability was higher than 0.70.
- Follow-up response rates (post-intervention and 3 months follow-ups).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention is delivered in a group format, which takes the form of a full day's training, focusing on ADHD diagnosis, its treatment, how to cope with the challenges related to living with ADHD, as well as coping with challenges of parenting a child with chronic health conditions. After this one day-intervention, the participants can continue in self-help groups, which meet once a week for a 2-hour evening session. User representatives lead these weekly self-help groups, which do not require user-fees and aim to offer practical tools, support and information to increase the parent's skills, knowledge and confidence. Participants are encouraged to adopt an active role in order to achieve a positive parent/provider partnership.
| Arm | Type | Receives |
|---|---|---|
| Peer co-led educational group | Experimental | Behavioral: Peer co-led educational groupThe intervention delivered in a group format is added to treatment as usual. After the parents participate in the one day-intervention, they can continue in self-help groups, which meet once a week for a 2-hour evening session. User representatives lead these weekly self-help groups, which do not require user-fees and aim to offer practical tools, support and information to increase the parent's skills, knowledge and confidence. |
| Control group | Other | Behavioral: Comparator treatment as usualThe control goup will receive treatment as usual. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parents of children aged 6 - 12 with a formal diagnosis of ADHD, following a standardised assessment.
Key exclusion criteria (2 listed)
- Participants already taking part in research on a parenting intervention will also be ineligible to participate.
- Families attending other parenting groups
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 |
|---|---|---|
| Peer co-led educational groupThe intervention is delivered in a group format, which takes the form of a full day's training, focusing on ADHD diagnosis, its treatment, how to cope with the challenges related to living with ADHD, as well as coping with challenges of parenting a child with chronic health conditions. After this one day-intervention, the participants can continue in self-help groups, which meet once a week for a 2-hour evening session. User representatives lead these weekly self-help groups, which do not require user-fees and aim to offer practical tools, support and information to increase the parent's skills, knowledge and confidence. Participants are encouraged to adopt an active role in order to achieve a positive parent/provider partnership. | Behavioural | Peer co-led educational group |
| Comparator treatment as usualControl group will receive treatment as usual, including different treatment options that can help alleviate the symptoms of ADHD and arm families with the tools needed to better handle problem behaviors when they arise. These interventions include: medication, psychotherapy, or a combination of these two approaches. | Behavioural | Control group |
Primary outcome
Feasibility of recruitment
Time frame: Over a two year study period
Feasibility of recruitment will be assessed by determining the recruitment rate, by monitoring patient screening and subsequent agreement to participate.
Satisfaction with the intervention
Time frame: From baseline to 12- and 52-weeks follow-up
Parent satisfaction will be measured by means of the client satisfaction Questionnaire, CSQ-3 as it applies to the group-based educational programme. The scale comprises three items measured on a scale from 1 (not satisfied) to 4 (very satisfied).
Parental activation
Time frame: From baseline to 12- and 52-weeks follow-up
Parental activation will be measure with the P-PAM-13. The 13-items P-PAM has four possible response options ranging from (1) strongly disagree, to (4) strongly agree, and an additional 'not applicable' option.
8 secondary outcomes
Parental well-being
Time frame: From baseline to 12- and 52-weeks follow-up
Parental quality of life
Time frame: From baseline to 12- and 52-weeks follow-up
Shared decision making
Time frame: From baseline to 12- and 52-weeks follow-up
Parental involvement in treatment decision
Time frame: From baseline to 12- and 52-weeks follow-up
Beliefs about medicines
Time frame: From baseline to 12- and 52-weeks follow-up
Adherence
Time frame: From baseline to 12- and 52-weeks follow-up
ADHD Scale Parent Version
Time frame: From baseline to 12- and 52-weeks follow-up
Level of functioning of children in Child
Time frame: From baseline to 12- and 52-weeks follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Derived from this study: PubMed 33268416Mundal I, Grawe RW, Hafstad H, De Las Cuevas C, Lara-Cabrera ML. Effects of a peer co-facilitated educational programme for parents of children with ADHD: a feasibility randomised controlled trial protocol. BMJ Open. 2020 Dec 2;10(12):e039852. doi: 10.1136/bmjopen-2020-039852.
- Individual participant dataSharing planned: No. We anticipate that anonymised trial data may be shared with other researchers to enable international prospective meta-analyses.
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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. This study is not recruiting at the moment.
Ingunn P. Mundal, PhD principal investigator
Molde University College
Mariela Loreto Lara Cabrera, PhD principal investigator
St Olavs Hospital, Department of research and development AFFU, and NTNU
Rolf W. Gråwe, Phd prof study director
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Peer co-led educational group and Comparator treatment as usual in people with Attention Deficit Disorder With Hyperactivity, run by Norwegian University of Science and Technology.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: Over a two year study period). The study lists 3 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 NCT04010851, which also lists 1 linked publication.
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 14 Feb 2022.