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

NCT04010851 | Withdrawn

• 1 other identifier: 2018/1196/REK Mid Norway
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Parental activation; Peer co-led education

Outcome Measures

Primary Outcomes (3)

• Feasibility of recruitment

  Feasibility of recruitment will be assessed by determining the recruitment rate, by monitoring patient screening and subsequent agreement to participate.

  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).

  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.

  From baseline to 12- and 52-weeks follow-up

Secondary Outcomes (8)

• Parental well-being

  From baseline to 12- and 52-weeks follow-up

• Parental quality of life

  From baseline to 12- and 52-weeks follow-up

• Shared decision making

  From baseline to 12- and 52-weeks follow-up

• Parental involvement in treatment decision

  From baseline to 12- and 52-weeks follow-up

• Beliefs about medicines

  From baseline to 12- and 52-weeks follow-up

Other Outcomes (1)

• Participation in treatment

  From baseline to 12- and 54-weeks follow-up.

Study Arms (2)

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.

Behavioral: Peer co-led educational group

Control group

OTHER

The control goup will receive treatment as usual.

Behavioral: Comparator treatment as usual

Interventions

Peer co-led educational group 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.

Peer co-led educational group

Comparator treatment as usual 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.

Control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• Molde University College: collaborator

Related Publications (1)

• 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.

  PMID: 33268416 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ingunn P. Mundal, PhD

  Molde University College

  PRINCIPAL INVESTIGATOR

• Mariela Loreto Lara Cabrera, PhD

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

  PRINCIPAL INVESTIGATOR

• Rolf W. Gråwe, Phd prof

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 8, 2019
• Study Start: March 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share