Clinical trial NCT04010851: The Effects of a Peer Co-led Educational Programme for Parents of Children With ADHD
Official title: The Effects of a Peer Co-led Educational Programme for Parents of Children With ADHD: A Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Parental activation
Peer co-led education
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Molde University College
First posted: 2019-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Over a two year study period
measure: Satisfaction with the intervention
timeFrame: From baseline to 12- and 52-weeks follow-up
measure: Parental activation
timeFrame: From baseline to 12- and 52-weeks follow-up
Secondary outcomes:
measure: Parental well-being
timeFrame: From baseline to 12- and 52-weeks follow-up
measure: Parental quality of life
timeFrame: From baseline to 12- and 52-weeks follow-up
measure: Shared decision making
timeFrame: From baseline to 12- and 52-weeks follow-up
measure: Parental involvement in treatment decision
timeFrame: From baseline to 12- and 52-weeks follow-up
measure: Beliefs about medicines
timeFrame: From baseline to 12- and 52-weeks follow-up
measure: Adherence
timeFrame: From baseline to 12- and 52-weeks follow-up
measure: ADHD Scale Parent Version
timeFrame: From baseline to 12- and 52-weeks follow-up
measure: Level of functioning of children in Child
timeFrame: From baseline to 12- and 52-weeks follow-up
Other outcomes:
measure: Participation in treatment
timeFrame: From baseline to 12- and 54-weeks follow-up.
Locations:
Study officials:
affiliation: Molde University College
name: Ingunn P. Mundal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Olavs Hospital, Department of research and development AFFU, and NTNU
name: Mariela Loreto Lara Cabrera, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology
name: Rolf W. Gråwe, Phd prof
role: STUDY_DIRECTOR
References:
citation: 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.