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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06339333
Other study ID # RRECB0523EC
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date May 12, 2024
Est. completion date April 1, 2025

Study information

Verified date May 2024
Source University College Dublin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this Randomised Control Trial is to evaluate a Psychologist Guided Self Help Video Parenting Programme based on principles of Acceptance and Commitment Therapy (ACT) The main questions it aims to answer are: Primary Objectives 1. Is ACT Now GAIN Later: a Psychologist Guided Self Help Video Parenting Programme based on principles of ACT effective in increasing parental psychological flexibility (measured by Psy-Flex, tool which measures psychological flexibility)? Please find attached. 2. Is ACT Now GAIN Later: a Psychologist Guided Self Help Video Parenting Programme based on principles of ACT effective in decreasing child challenging behaviour (measured by the Eyberg Child Behavior Inventory)? Please find attached. Secondary Objectives 1. Is ACT Now GAIN Later: an ACT based Parenting Programme, effective in improving parent-child relationships (measured by the Child-Parent Relationship Scale)? Please find attached. 2. Does ACT Now GAIN Later increase parental well-being as measured by (Depression Anxiety Stress Scale, Parenting Stress Index and Goal Based Outcome Tool)? Please find attached. 3. Does ACT Now GAIN Later increase parental self-efficacy (TOPSE and Parental Sense of Competence scale)? Please find attached. Participants will complete a 7 week psychologist guided parenting intervention. Researchers will compare waitlist groups to see if there are differences in psychological flexibility, child behaviour, parent-child relationships, parental well-being or parental self-efficacy.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 150
Est. completion date April 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 12 Years
Eligibility Inclusion Criteria: - Parents of children from the ages of 3-12 will be included in this study. - Parents of children with challenging behavior. Exclusion Criteria: - Parents of children outside of the age range 3-12 years old - Parents of children who do not have challenging behavior

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
ACT Now GAIN Later
ACT Now GAIN Later is a Psychologist Guided Self Help Parenting Programme. This has been developed by HSE Senior psychologist,. Dr. Michelle Howard to help parents manage challenging behaviors in their children. Parents of children who are referred to HSE Psychology Services with behavioural difficulties are invited to participate in this 7 week programme.
Other:
Control Group
Waitlist Group

Locations

Country Name City State
Ireland Longford Primary Care Centre Longford

Sponsors (1)

Lead Sponsor Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parental Psychological Flexibility Psy-Flex: The scale ranges from a minimum score of 6 to a maximum score of 30. Higher scores indicate higher levels of psychological flexibility. Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
Primary Child Behaviour Eyberg Child Behaviour Inventory: The scale ranges from 0 - 36. Higher scores indicate more problematic behaviours at greater frequency. Norms also exist for clinical cut off's. Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
Secondary Parent-Child Relationships Child-Parent Relationship Scale: There are two sub scales; closeness and conflict. On the closeness sub scale, higher scores indicate better/ more positive parent-child relationships. On the conflict sub scale, lower scores indicate less conflict and higher scores indicate more conflict in the relationship. Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
Secondary Parental Well-Being Depression Anxiety Stress Scale: Scale range is 0 - 42. Higher scores indicate more distress. Subscales for anxiety, depression and stress. Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
Secondary Parental Self-Efficacy Parental Sense of Competence Scale: Lower scores indicate lower parental sense of competence and high scores indicate high parental sense of competence. Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
Secondary Parental Self-Efficacy Parenting Stress Index: Scores range from 18-90. Lower scores indicate lower levels of parenting stress. Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
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