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

Norwegian University of Science and Technology

Status: Withdrawn

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Behavioral: Comparator treatment as usual; Behavioral: Peer co-led educational group

Study type: Interventional

Funder types: Other

Identifiers

NCT04010851

2018/1196/REK Mid Norway

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Peer co-led educational group

Experimental group

Description:

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.

Treatment:

Behavioral: Peer co-led educational group

Control group

Other group

Description:

The control goup will receive treatment as usual.

Treatment:

Behavioral: Comparator treatment as usual