- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06339333
Evaluation of ACT Now GAIN Later
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
- 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.
- 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
- 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.
- 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.
- 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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Longford, Ireland
- Longford Primary Care Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ACT Now GAIN Later
This group will receive a 7-week psychologist guided parenting intervention.
|
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.
|
Waitlist Group
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RRECB0523EC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
Marmara UniversityCompleted
-
University of New MexicoActive, not recruitingChild Abuse | Parenting | Child Behavior | Child Development | Delinquency | Criminal Behavior | Child NeglectUnited States
-
Boston Medical CenterValhalla Foundation; Centering Healthcare Institute; Overdeck Family foundationRecruitingParent-Child Relations | Parenting | Child Behavior | Child DevelopmentUnited States
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingParent-Child Relations | Parenting | Child Behavior | Child MaltreatmentUnited States
-
University of OregonCompleted
-
Children's Hospital of PhiladelphiaPNC FoundationTerminatedChild Behavior | Child Development | Child Behavior ProblemUnited States
-
Washington University School of MedicineNational Institute of Mental Health (NIMH)Active, not recruiting
-
Rutgers, The State University of New JerseyEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedParenting | Language Development | Behavior, Child | LiteracyUnited States
-
University of MinnesotaNational Institute of Mental Health (NIMH)CompletedParent-Child Relations | Parents | Behavior Problem | Behavior, ChildUnited States
-
University of Southern CaliforniaSafe Water and AIDS Project; Early Childhood Development Network for Kenya...Active, not recruitingChild Behavior | Child Development | Language, ChildKenya
Clinical Trials on ACT Now GAIN Later
-
Stanford UniversityNational Institute on Drug Abuse (NIDA)CompletedBehavior | Binge Eating | Smoking, TobaccoUnited States