Clinical trial NCT03916172: Evaluation of Psychological Intervention for Parents of Adolescents
Official title: Randomised Evaluation of Brief Psychological Intervention for Parents of Adolescents: The Open Door Approach to Parenting Teenagers (APT), in London, England
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parent-Child Relations
Keywords: Adolescence
Stress
Parent-adolescent relationship
Lead sponsor: Open Door Young People's Service
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adolescence is a challenging period for young people and their parents. Changes during adolescence bring increases in social, psychological and behavioural problems (such as gang membership and drug abuse), and most long-lasting mental health problems start during this period. One of the strongest predictors of adolescent outcomes is the quality of parenting they receive at this stage. Parents often struggle with parenting adolescents, leading to feelings of stress and incompetence which, when reaching clinical levels, result in physical and mental health difficulties for parents and their children. This puts significant strain on community, social and mental health services. While the effectiveness of programmes to support parents of adolescents is certain, most are group-based and struggle to retain participants, especially amongst those who need help most: clinically stressed, and single parents. There are no standard care pathways for these parents, which leads to chronic problems and high long-term cost. The present study aims to measure the effectiveness of the Open Door's Approach to Parenting Teenagers (APT) - a manualised, six-session individual parenting intervention focusing on the relationship between parent and adolescent. This brief intervention, developed with awareness of the organisational realities and overarching aims of the National Health Service (NHS), has shown good results amongst clinically stressed parents in a pilot trial. The next phase in evaluating this approach is ruling out spontaneous recovery, by randomly assigning participants to APT or a waiting list control and comparing their results after the intervention, and again after 3 months. If successful, this study will have a major impact on communities around the United Kingdom (UK) - offering an evidence-based, non-proprietary intervention that can be easily disseminated.

Detailed description: This study is the next step in the evaluation trajectory of the Open Door Approach to Parenting Teenagers (APT), and is a randomised controlled trial investigating whether receiving APT is more effective than being on a Waiting List (WL) in a sample of 60 parents of adolescents. We hypothesise that in comparison to those on the WL, those receiving APT will show significant improvements in:

* parental stress;
* parent-adolescent relationship;
* adolescent and parent wellbeing and mental health outcomes;

Secondary aims of the study will include:

* Ascertaining treatment fidelity
* Disseminating outcomes to inform policymakers, commissioners and providers, to facilitate evidence-based decisions about community services.

Procedure This trial will be carried out at two clinical sites in North London over 12months.

Method:

Parents and adolescents in the APT condition will be measured 3 times: at baseline, end-of-treatment, and follow-ups at three after the end-of-treatment. Those in WL will be measured three times from pre-treatment to three months follow-up. Then they will be offered APT. Measures are grouped into four batteries: for the parent, the adolescent, the therapist and an observer, and they will measure changes in parental stress, perceptions of the parent about their adolescent's psychopathology and relational problems, aspects of parenting relevant to aetiology and treatment of adolescent issues. The batteries also include variables mediating recovery, therapeutic alliance, health services utilisation and therapists' adherence to the ATP model.

Analysis plan:

The primary outcome will be analysed using within- and between-groups mean differences to estimate treatment effects. Results will be disseminated through scientific papers, academic conferences, the Open Door (OD) website, and reports will be distributed among educational and health institutions in our local network. If results have merit, the intervention manual will be published, and training will be offered to professionals outside OD. If successful, we anticipate this study to have a major impact on communities around the UK. It is a non-proprietary intervention that can be easily disseminated.

Eligibility criteria: Inclusion Criteria:

* Being a parent of an adolescent aged 11-18 years
* Adolescent currently lives with parent for a minimum of 2 days/week
* Parent demonstrates clinically significant levels of concern on primary measure (Stress Index for Parents of Adolescents)
* Parent must be proficient in English so they may fully understand the material presented to them during the research study

Exclusion Criteria:

* Parent currently receiving treatment for psychotic illness
* Parent previously received APT intervention
* Adolescent has severe developmental disorder (e.g. Autism Spectrum Disorder) or serious life threatening health impairment
* Adolescent currently receiving individual psychotherapeutic treatment

Primary outcomes:
measure: Stress Index for Parents of Adolescents (SIPA)
timeFrame: 5 months
Secondary outcomes:
measure: Strengths And Difficulties Questionnaire Parent Version (SDQ-P)
timeFrame: 5 months
measure: Strengths and Difficulties Questionnaire Young Person Version (SDQ-YP)
timeFrame: 5 Months
measure: Alabama Parenting Questionnaire - Short Form (APQ-SF)
timeFrame: 5 months
measure: Patient Health Questionnaire Module 9 (PHQ-9)
timeFrame: 5 months
measure: Generalised Anxiety Disorder Screener (GAD-7)
timeFrame: 5 months
measure: Alabama Parenting Questionnaire Young Person version (APQ-YP)
timeFrame: 5 months
measure: EQ-5D-5L
timeFrame: 5 months
measure: Reflective Function Questionnaire (RFQ)
timeFrame: 5 months
measure: Conflict Behaviour Questionnaire (CBQ)
timeFrame: 5 months
measure: Parenting Scale (PS)
timeFrame: 5 months
measure: Goal Based Measure
timeFrame: 5 months
measure: Working Alliance Inventory-Short Form-Client (WAI-SF-C)
timeFrame: 5 months
measure: Working Alliance Inventory-Short Form-Therapist (WAI-SF-T)
timeFrame: 5 months
measure: Working Alliance Inventory-Observer (WAI-O)
timeFrame: 5 months
measure: Experience of Services Questionnaire
timeFrame: 5 months
measure: Adherence to the APT Model
timeFrame: 5 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Open Door Young People's Consultation Service
Study officials:
affiliation: Open Door Young People's Consultation Service
name: Alex Desiatnikov
role: PRINCIPAL_INVESTIGATOR
References: