NCT03916172

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

12 months

First QC Date

April 12, 2019

Last Update Submit

April 12, 2019

Conditions

Keywords

AdolescenceStressParent-adolescent relationship

Outcome Measures

Primary Outcomes (1)

  • Stress Index for Parents of Adolescents (SIPA)

    This is a 112-item, self report that is structured into three main domain scores: Adolescent Domain (AD), Parent Domain (PD), and Adolescent-Parent Relationship Domain (APRD). The AD has 4 subscale scores: Moodiness/Emotional Lability (MEL), Social Isolation/Withdrawal (ISO), Delinquency/Antisocial (DEL), and Failure to Achieve or Persevere (ACH). The PD also has 4 subscale: Life Restrictions (LFR), Relationship with Spouse/Partner (REL), Social Alienation (SOC) and Incompetence/Guilt (INC). The APRD has no subscales. The Index of Total Parenting Stress (TPS) is a composite score computed from all items. Scores are then classified into broad ranges: normal, borderline, clinically significant and clinically severe.

    5 months

Secondary Outcomes (16)

  • Strengths And Difficulties Questionnaire Parent Version (SDQ-P)

    5 months

  • Strengths and Difficulties Questionnaire Young Person Version (SDQ-YP)

    5 Months

  • Alabama Parenting Questionnaire - Short Form (APQ-SF)

    5 months

  • Patient Health Questionnaire Module 9 (PHQ-9)

    5 months

  • Generalised Anxiety Disorder Screener (GAD-7)

    5 months

  • +11 more secondary outcomes

Study Arms (2)

APT Treatment

EXPERIMENTAL

Participants in this arm will receive the Open Door Approach to Parenting Teenagers (APT). It offers 6 weekly 50-minute appointments with an optional 7th review session.

Behavioral: The Open Door Approach to Parenting Teenagers (APT)

Waiting List

NO INTERVENTION

Participants in this group will be placed on a waiting list and will receive APT treatment after no longer than 25 weeks.

Interventions

APT works on a one-to-one or couple basis. It offers 6 weekly 50-minute appointments with an optional 7th review session. The practitioners delivering the intervention have qualifications in psychology, or significant experience of working with adolescent populations, and have undertaken training and supervision in the model. Its aim is to help the parent manage the parenting of their teenager more effectively and establish a more balanced relationship by eliciting their views, feelings, and understanding of their teenager and their relationship, discussing their parental identity and role, carefully examining communication, responses, and information giving, and supporting appropriate boundary making. This is achieved through a collaborative development of strategies, psychoeducation and behavioural experiments.

APT Treatment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Open Door Young People's Consultation Service

London, N8 8PL, United Kingdom

RECRUITING

Study Officials

  • Alex Desiatnikov

    Open Door Young People's Consultation Service

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Alex Desiatnikov

Study Record Dates

First Submitted

April 12, 2019

First Posted

April 16, 2019

Study Start

December 12, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations