Psychological FlexibilityNCT06339333
Evaluation of ACT Now GAIN Later
A study testing ACT Now GAIN Later in people with Psychological Flexibility and Child Behavior, run by University College Dublin at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Flexibility, Child Behavior, Relationship, Parent Child
- What is being tested?
- ACT Now GAIN Later
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIreland
- Study dates
- 12 May 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents of children from the ages of 3-12 will be included in this study.
- Parents of children with challenging behavior.
Who cannot join
- Parents of children outside of the age range 3-12 years old
- Parents of children who do not have challenging behavior
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
- Conditions
- Psychological Flexibility, Child Behavior, Relationship, Parent Child, Well-Being, Psychological, Self-efficacy
- Being tested
- ACT Now GAIN Later, Control Group
- Medical subject headings
- Child Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT Now GAIN LaterBehavioural
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.
Control GroupOther
Waitlist Group
| Study group | Role | What they receive |
|---|---|---|
| ACT Now GAIN Later | Experimental | This group will receive a 7-week psychologist guided parenting intervention. Receives: 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
Parental Well-Being
Depression Anxiety Stress Scale: Scale range is 0 - 42. Higher scores indicate more distress. Subscales for anxiety, depression and stress.
Measured: Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
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.
Measured: Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
Parental Self-Efficacy
Parenting Stress Index: Scores range from 18-90. Lower scores indicate lower levels of parenting stress.
Measured: Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start12 May 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological FlexibilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This quantitative study will be a two arm randomised control trial with an intervention group and waitlist group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339333
- Sponsor's protocol ID
- RRECB0523EC
- Status last verified
- May 2024
- First submitted
- 29 Feb 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ACT Now GAIN Later: a Psychologist Guided Self Help Video Parenting Programme Based on Principles of Acceptance and Commitment Therapy (ACT)
- ClinicalTrials.gov ID
- NCT06339333
- Acronym / sponsor ID
- RRECB0523EC
- Conditions
- Psychological Flexibility, Child Behavior, Relationship, Parent Child, Well-Being, Psychological, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 12 May 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This quantitative study will be a two arm randomised control trial with an intervention group and waitlist group.
| Arm | Type | Receives |
|---|---|---|
| ACT Now GAIN Later | Experimental | Behavioral: ACT Now GAIN LaterThis group will receive a 7-week psychologist guided parenting intervention. |
| Waitlist Group | Active comparator | Other: Control GroupThis group will receive pre and post measures but will not receive an intervention until after the final measures have been administered. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parents of children from the ages of 3-12 will be included in this study.
- Parents of children with challenging behavior.
Key exclusion criteria (2 listed)
- Parents of children outside of the age range 3-12 years old
- Parents of children who do not have challenging behavior
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT Now GAIN LaterACT 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. | Behavioural | ACT Now GAIN Later |
| Control GroupWaitlist Group | Other | Waitlist Group |
Primary outcome
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.
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.
4 secondary outcomes
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.
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.
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 Self-Efficacy
Time frame: Pre and Post Intervention (week 1 and week 7 - end of the intervention). Also 3 and 6 months post intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT Now GAIN Later in people with Psychological Flexibility and Child Behavior, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.