Back to resultsSowing the Seeds of Confidence: Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds (StS)
Primary Purpose
Anxiety, Parenting
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Parenting programme (cognitive behavioural) aimed at reducing generational transmission of anxiety
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- current or recent (within 2 years) primary diagnosis of anxiety disorder or self-report of clinically impairing anxiety problem within last 2 years,
- parent of child aged 12-47 months at time of intervention,
- access to an internet connection and smart phone/computer will be required to take part,
- male or female,
- resident in England,
- and over the age of 18
Exclusion Criteria:
- current severe co-morbid diagnoses, e.g. psychosis or acute suicidal risk (as the nature of the intervention is brief and in a group, the level of support needed to keep those with severe mental health disorders safe will not be available),
- current alcohol or drugs misuse
Sites / Locations
- South London and Maudsley NHS Trust
Outcomes
Primary Outcome Measures
Number of participants who consented to take part as percentage of those who expressed initial interest.
Percentage of count (people consent to take part / people expressing interest in response to advertising). To indicate feasibility of larger trial.
Actual attendance at each session as percentage of expected attendance
Percentage of count (people scheduled to attend each session / people who actually attended). To indicate feasibility of larger trial.
Number of participants who provided completed questionnaire measures
Percentage of recruited participants who completed questionnaire measures at each of the three collection timepoints.
Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017)
Validated measure of acceptability of an intervention - Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017)
Open text questions about participants' views on the acceptability
Open text questions to gather qualitative information about participants' perspectives on usefulness, accessibility and unintended negative consequences
Secondary Outcome Measures
Change in score on Brief Infant Toddler Social and Emotional Assessment (Briggs-Gowan, Carter et al. 2002)
Parent report measure of child social, emotional and behavioural difficulties. This is a 42-item parent-report screening tool validated with parents of children aged 12 to 47 months. Maximum score is 84 and minimum score is 0. The higher the score the worse the outcome.
Change in score on Depression Anxiety Stress Scale (Henry and Crawford 2005)
Parent report questionnaire measure of stress, anxiety and depression in parents. This is a 21-item scale. The minimum score is 0 and the maximum score is 63, higher score is a worse outcome.
Bespoke questionnaire about self-reported use and confidence in behaviours specifically targeted in intervention.
Bespoke questionnaire about 8 specific parenting behaviours targeted in the intervention, each rated on a 5-point Likert scale (4 are reverse scored). Minimum score is 0 and maximum score is 40. The higher the score the 'worse' the outcome.
Full Information
NCT ID
NCT04556331
First Posted
September 7, 2020
Last Updated
February 17, 2021
Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04556331
Brief Title
Sowing the Seeds of Confidence: Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds
Acronym
StS
Official Title
Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds With the Aim of Reducing Transmission of Anxiety Through Generations: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To pilot a brief group early intervention aimed at reducing or preventing the intergenerational transmission of anxiety, with parents whose child is between 12 and 47 months. To explore feasibility and acceptability of such an intervention with this population.
Detailed Description
All participants will attend two group sessions of 'psychoeducation' (psychologically informed information about the topic of transmitting anxiety) and cognitive-behavioural strategies aimed at reducing the transmission of anxiety from parent to young child. The two sessions will be delivered online via Microsoft Teams, last 2 hours each and will run one week apart. Outcome and acceptability measures will be collected before, immediately after, and 6 weeks after the intervention. Feasibility data (e.g. drop-out rate) will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Parenting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Parenting programme (cognitive behavioural) aimed at reducing generational transmission of anxiety
Intervention Description
'Psychoeducation' (psychologically informed information about the topic of transmitting anxiety) and cognitive-behavioural strategies aimed at reducing the transmission of anxiety from parent to young child. These will be shared with a group of maximum 8 remotely delivered, in a didactic format.
Primary Outcome Measure Information:
Title
Number of participants who consented to take part as percentage of those who expressed initial interest.
Description
Percentage of count (people consent to take part / people expressing interest in response to advertising). To indicate feasibility of larger trial.
Time Frame
Total across recruitment period (up to 11 weeks, October 2020 to mid December 2020)
Title
Actual attendance at each session as percentage of expected attendance
Description
Percentage of count (people scheduled to attend each session / people who actually attended). To indicate feasibility of larger trial.
Time Frame
Total across intervention period (up to 9 weeks, mid October 2020 to mid December 2020)
Title
Number of participants who provided completed questionnaire measures
Description
Percentage of recruited participants who completed questionnaire measures at each of the three collection timepoints.
Time Frame
Total across intervention and 6 week follow-up period (up to 15 weeks, mid October 2020 to January 2021)
Title
Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017)
Description
Validated measure of acceptability of an intervention - Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017)
Time Frame
Collected twice: immediately after intervention attendance (same day) and after 6 weeks.
Title
Open text questions about participants' views on the acceptability
Description
Open text questions to gather qualitative information about participants' perspectives on usefulness, accessibility and unintended negative consequences
Time Frame
Collected twice: immediately after intervention attendance (same day) and after 6 weeks.
Secondary Outcome Measure Information:
Title
Change in score on Brief Infant Toddler Social and Emotional Assessment (Briggs-Gowan, Carter et al. 2002)
Description
Parent report measure of child social, emotional and behavioural difficulties. This is a 42-item parent-report screening tool validated with parents of children aged 12 to 47 months. Maximum score is 84 and minimum score is 0. The higher the score the worse the outcome.
Time Frame
Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.
Title
Change in score on Depression Anxiety Stress Scale (Henry and Crawford 2005)
Description
Parent report questionnaire measure of stress, anxiety and depression in parents. This is a 21-item scale. The minimum score is 0 and the maximum score is 63, higher score is a worse outcome.
Time Frame
Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.
Title
Bespoke questionnaire about self-reported use and confidence in behaviours specifically targeted in intervention.
Description
Bespoke questionnaire about 8 specific parenting behaviours targeted in the intervention, each rated on a 5-point Likert scale (4 are reverse scored). Minimum score is 0 and maximum score is 40. The higher the score the 'worse' the outcome.
Time Frame
Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
current or recent (within 2 years) primary diagnosis of anxiety disorder or self-report of clinically impairing anxiety problem within last 2 years,
parent of child aged 12-47 months at time of intervention,
access to an internet connection and smart phone/computer will be required to take part,
male or female,
resident in England,
and over the age of 18
Exclusion Criteria:
current severe co-morbid diagnoses, e.g. psychosis or acute suicidal risk (as the nature of the intervention is brief and in a group, the level of support needed to keep those with severe mental health disorders safe will not be available),
current alcohol or drugs misuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fiona Challacombe, PhD DClinPsy
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
South London and Maudsley NHS Trust
City
London
ZIP/Postal Code
SE8
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sowing the Seeds of Confidence: Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds
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