NCT06339333

Brief 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. 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. 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.
  3. 3.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.
  4. 4.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.
  5. 5.Does ACT Now GAIN Later increase parental self-efficacy (TOPSE and Parental Sense of Competence scale)? Please find attached.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 29, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

May 12, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

February 29, 2024

Last Update Submit

May 13, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (4)

  • Parent-Child Relationships

    Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.

  • Parental Well-Being

    Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.

  • Parental Self-Efficacy

    Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.

  • Parental Self-Efficacy

    Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.

Study Arms (2)

ACT Now GAIN Later

EXPERIMENTAL

This group will receive a 7-week psychologist guided parenting intervention.

Behavioral: ACT Now GAIN Later

Waitlist Group

ACTIVE COMPARATOR

This group will receive pre and post measures but will not receive an intervention until after the final measures have been administered.

Other: Control Group

Interventions

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.

ACT Now GAIN Later

Waitlist Group

Waitlist Group

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parents of children from the ages of 3-12 will be included in this study.
  • Parents of children with challenging behavior.

You may not qualify if:

  • Parents of children outside of the age range 3-12 years old
  • Parents of children who do not have challenging behavior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longford Primary Care Centre

Longford, Ireland

Location

MeSH Terms

Conditions

Child BehaviorPsychological Well-Being

Interventions

Control Groups

Condition Hierarchy (Ancestors)

BehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: This quantitative study will be a two arm randomised control trial with an intervention group and waitlist group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2024

First Posted

April 1, 2024

Study Start

May 12, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations