The Effects of a Peer Co-led Educational Programme for Parents of Children With ADHD

NCT ID: NCT04010851

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2023-07-01

Brief 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. 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).

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peer co-led educational group

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.

Group Type: EXPERIMENTAL

Peer co-led educational group

Intervention Type: BEHAVIORAL

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.

Control group

The control goup will receive treatment as usual.

Group Type: OTHER

Comparator treatment as usual

Intervention Type: BEHAVIORAL

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.

Interventions

Peer co-led educational group

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.

Intervention Type: BEHAVIORAL

Comparator treatment as usual

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Parents of children aged 6 - 12 with a formal diagnosis of ADHD, following a standardised assessment.

Exclusion Criteria

• Participants already taking part in research on a parenting intervention will also be ineligible to participate.
• Families attending other parenting groups

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Molde University College

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingunn P. Mundal, PhD

Role: PRINCIPAL_INVESTIGATOR

Molde University College

Mariela Loreto Lara Cabrera, PhD

Role: PRINCIPAL_INVESTIGATOR

St Olavs Hospital, Department of research and development AFFU, and NTNU

Rolf W. Gråwe, Phd prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

References

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.

Reference Type: DERIVED

PMID: 33268416 (View on PubMed)

Other Identifiers

2018/1196/REK Mid Norway

Identifier Type: -

Identifier Source: org_study_id