Clinical trial NCT04556331: Sowing the Seeds of Confidence: Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds
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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Parenting
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2020-09-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of participants who consented to take part as percentage of those who expressed initial interest.
timeFrame: Total across recruitment period (up to 11 weeks, October 2020 to mid December 2020)
measure: Actual attendance at each session as percentage of expected attendance
timeFrame: Total across intervention period (up to 9 weeks, mid October 2020 to mid December 2020)
measure: Number of participants who provided completed questionnaire measures
timeFrame: Total across intervention and 6 week follow-up period (up to 15 weeks, mid October 2020 to January 2021)
measure: Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017)
timeFrame: Collected twice: immediately after intervention attendance (same day) and after 6 weeks.
measure: Open text questions about participants' views on the acceptability
timeFrame: Collected twice: immediately after intervention attendance (same day) and after 6 weeks.
Secondary outcomes:
measure: Change in score on Brief Infant Toddler Social and Emotional Assessment (Briggs-Gowan, Carter et al. 2002)
timeFrame: Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.
measure: Change in score on Depression Anxiety Stress Scale (Henry and Crawford 2005)
timeFrame: Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.
measure: Bespoke questionnaire about self-reported use and confidence in behaviours specifically targeted in intervention.
timeFrame: Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: South London and Maudsley NHS Trust
Study officials:
affiliation: King's College London
name: Fiona Challacombe, PhD DClinPsy
role: PRINCIPAL_INVESTIGATOR
References: