Evaluation of ACT Now GAIN Later

May 13, 2024 updated by: University College Dublin

Evaluation of ACT Now GAIN Later: a Psychologist Guided Self Help Video Parenting Programme Based on Principles of Acceptance and Commitment Therapy (ACT)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Ireland
      • Longford, Ireland
        • Longford Primary Care Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACT Now GAIN Later
This group will receive a 7-week psychologist guided parenting 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.
Active Comparator: Waitlist Group
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
Waitlist Group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parental Psychological Flexibility
Time Frame: Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
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
Time Frame: Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parent-Child Relationships
Time Frame: Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
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.
Parental Well-Being
Time Frame: Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
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.
Parental Self-Efficacy
Time Frame: Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
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.
Parental Self-Efficacy
Time Frame: Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College Dublin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RRECB0523EC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Child Behavior

Clinical Trials on ACT Now GAIN Later

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings